REYKJAVIK, Iceland, May 09, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in the BofA Securities Healthcare Conference 2025, which will be held in Las Vegas, Nevada, May 13-15, 2025. Members of the management team will host one-on-one meetings at the conference.... Read More

Total Revenues in the first quarter of 2025 reached $132.8 million, compared to $36.9 million in the same period last year, representing a 260% increase Product Revenues in the first in the first quarter of 2025 reached $109.9 million, compared to $12.4 million in the same period last year, representing a 786% increase Adjusted EBITDA in the first quarter of 2025 was $20.5 million compared to negative $38.4 million in 2023... Read More

REYKJAVIK, Iceland, May 07, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO) (the “Company”) a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today issued a statement on the anticipated impact of potential tariffs on imported pharmaceuticals to the United States. Alvotech expects that potential U.S. tariffs on imported pharmaceuticals should have minimal... Read More

The U.S. FDA has approved SELARSDI™ (ustekinumab-aekn) as interchangeable with the reference biologic Stelara ® (ustekinumab) in all presentations matching the reference product, effective as of April 30, 2025 SELARSDI is approved for all indications matching the reference product SELARSDI is indicated for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and pediatric patients 6... Read More

REYKJAVIK, Iceland, May 02, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will release financial results for the first quarter ended March 31, 2025, after U.S. markets close on Wednesday, May 7, 2025. Alvotech will also conduct a conference call with analysts to present the... Read More

REYKJAVIK, Iceland, March 27, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the appointment of Dr. Balaji V. Prasad as Chief Strategy Officer. A medical doctor by training, Dr. Prasad has 25 years' experience in the pharmaceutical industry, first as a consultant and... Read More

Total Revenues in 2024 reached $492 million, representing a 427% increase over prior year Product Revenues in 2024 reached $273 million, representing a 462% increase over prior year Adjusted EBITDA in 2024 was $108.3 million compared to negative $291 million in 2023 Submissions in major global markets were made in 2024 for three new proposed biosimilars. All applications have been subsequently accepted by the relevant... Read More

REYKJAVIK, Iceland, PISCATAWAY, N.J. and LONDON, March 26, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacturing of biosimilar medicines for patients worldwide, Kashiv Biosciences LLC (“Kashiv”), a fully integrated biopharmaceutical company headquartered in New Jersey, US, and Advanz Pharma, a UK-headquartered global pharmaceutical company with a... Read More

REYKJAVIK, Iceland and STOCKHOLM, March 20, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the acquisition of Xbrane Biopharma AB’s (“Xbrane”) R&D operations and a biosimilar candidate (the “Acquisition”), further expanding Alvotech’s development capabilities, and establishing a... Read More

HYDERABAD, India and REYKJAVIK, Iceland, March 18, 2025 (GLOBE NEWSWIRE) -- Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as “Dr. Reddy’s”) and Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug... Read More

REYKJAVIK, Iceland, March 07, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in Barclays 27th Annual Global Healthcare Conference, which will be held in Miami, Florida on March 11-13, 2025. Robert Wessman, founder, chairman and CEO and members of the management team... Read More

Addition is part of the annual reconstitution of the Nasdaq Biotech Index (NBI) Inclusion criteria include minimum market capitalization and daily trading volumes REYKJAVIK, Iceland, Dec. 23, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that its stock will be added to the Nasdaq... Read More

Total Revenues in the first nine months of 2024 increased by $300 million compared to same period in 2023, to $339 million, with Q3 revenues contributing $103 million Product revenues in the first nine months of 2024 increased over four-fold compared to the same period last year, to $128 million, with Q3 product revenues contributing $62 million License and other revenues for the first nine months of 2024 increased by $203... Read More

REYKJAVIK, Iceland, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in Citi’s 2024 Global Healthcare Conference in Miami, Florida on December 4, 2024, and in Evercore’s HealthCONx Conference in Coral Gables, Florida on December 5, 2024. Members of the management... Read More

REYKJAVIK, Iceland and LONDON, Nov. 04, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency (EMA) has... Read More

REYKJAVIK, Iceland, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, will release financial results for first nine months of the year ended September 30, 2024, after U.S. markets close on Wednesday, November 13, 2024, and will conduct a conference call with analysts to present the financial... Read More

REYKJAVIK, Iceland, Oct. 25, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in the Jefferies London Healthcare Conference, November 19-20, 2024. Members of the management team will host one-on-one meetings on both days. Alvotech will be presenting at the conference on... Read More

REYKJAVIK, Iceland, Oct. 10, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT03, a proposed biosimilar candidate to Prolia ® and Xgeva ® (denosumab). “EMA acceptance marks an important step... Read More

Alvotech is one of two companies known to have initiated a global or multi-country confirmatory patient study for a biosimilar candidate to Entyvio ® Sales of Entyvio (vedolizumab) were about $5.4 billion globally in the last 12 months up to June 30, 2024 Entyvio is indicated for the treatment of Ulcerative Colitis and Crohn’s disease REYKJAVIK, Iceland, Sept. 25, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global... Read More

REYKJAVIK, Iceland, Aug. 26, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announces its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference in New York. Members of the management team will hold an in-person fireside chat on September 5, 2024, starting at 5:35 pm EDT (21:35... Read More

Record Total Revenues of $236 million for the first six months of 2024, an over ten-fold increase compared to same period in 2023 Product revenues for the first six months were $66 million, a 190% increase from the same period last year, with Q2 product revenues contributing $53 million License and other revenues for the first six months increased to $170 million, with Q2 license and other revenues contributing $145 million... Read More

The approvals process is anticipated to be completed in the third quarter of 2025 REYKJAVIK, Iceland and LONDON, Aug. 15, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease... Read More

REYKJAVIK, Iceland, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, will release financial results for first half of the year ended June 30, 2024, after U.S. markets close on Thursday, August 15, 2024, and will conduct a conference call with analysts to present the financial results and recent... Read More

Launch of European-made Uzpruvo in Europe comes immediately upon expiry of exclusivity rights for the molecule used to treat certain conditions in gastroenterology 1 , dermatology and rheumatology Creates competition at earliest opportunity, enabling straightforward switching to broaden patient access and control costs in a growing market, with accessible indications currently estimated at approximately €2.4 billion... Read More

REYKJAVIK, Iceland, July 11, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the closing of its previously announced senior secured first lien term loan facility (the “Facility”). The closing has allowed Alvotech to refinance outstanding debt obligations, reduce the cost of capital and... Read More

Positive topline results demonstrate clinical similarity between AVT03 and the reference biologic, Prolia ® (denosumab) Two additional studies comparing the pharmacokinetics, safety, and tolerability of AVT03 to Prolia and Xgeva, respectively, have also met their primary endpoint Alvotech expects to file marketing applications for AVT03 later this year for major global markets REYKJAVIK, Iceland, July 02, 2024 (GLOBE... Read More

REYKJAVIK, Iceland, July 01, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today issued new shares to holders of subordinated convertible bonds, originally issued by Alvotech on November 16, 2022, and December 20, 2022, with maturity on December 20, 2025 (the “Convertible Bonds”). Today, Alvotech... Read More

REYKJAVIK, Iceland, July 01, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced certain preliminary, unaudited key financial information for the second quarter and six months ended June 30, 2024, as follows: Strong preliminary revenue growth with total revenues for the second quarter between... Read More

REYKJAVIK, Iceland , June 26, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that holders of the majority of subordinated convertible bonds, originally issued by Alvotech on November 16, 2022, and December 20, 2022, respectively, with maturity on December 20, 2025 (the “Convertible... Read More

Advanz Pharma secures rights to commercialize Alvotech’s biosimilar candidate for Eylea ® in Europe Advanz Pharma will leverage its existing specialty and hospital capabilities in Europe to ensure successful market registration, commercialization, and patient access REYKJAVIK, Iceland and LONDON, June 18, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and... Read More

STADA assumes marketing license for Alvotech’s proposed biosimilar referencing Prolia ® /Xgeva ® (denosumab) in Europe, including Switzerland and the UK, as well as rights in selected markets in Central Asia and the Middle East This partnership for the osteoporosis and cancer-related molecule builds on the two company’s existing strategic alliance in Europe. The first product launched through the alliance was Hukyndra ® , a... Read More

REYKJAVIK, Iceland, June 07, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the successful arrangement of a strategic refinancing transaction. The financing, led by GoldenTree Asset Management, with participation from other institutional investors (collectively, the “Lenders”), will... Read More

REYKJAVIK, Iceland, May 29, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in the Jefferies Healthcare Conference in New York on June 5-6, 2024. Alvotech will present and host investor and business meetings at the conference. Anil Okay, Chief Business Officer, is... Read More

Total revenues in Q1 2024 increased to $37 million compared to $16 million in the same period last year. Gross margin in Q1 2024 increased to $17 million, by $40 million compared to the same period last year. Alvotech signed new commercialization agreements for its high concentration interchangeable biosimilar to Humira ® in the U.S. and for its proposed biosimilar to Prolia ® and Xgeva ® in the U.S. and Europe. Alvotech... Read More

Dr. Reddy’s gets exclusive commercialization rights in the United States (U.S.) as well as semi-exclusive rights in Europe and United Kingdom (UK) Alvotech will be responsible for development and manufacture of the product HYDERABAD, India and REYKJAVIK, Iceland, May 21, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for... Read More

REYKJAVIK, Iceland, May 13, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will release financial results for the first quarter ended March 31, 2024, after U.S. markets close on Tuesday, May 21, 2024. Alvotech will also conduct a conference call with analysts to present the first... Read More

REYKJAVIK, Iceland, May 02, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that members of management would be participating in the upcoming BofA Securities Healthcare Conference 2024, which will be held on May 14-15, 2024 in Las Vegas, NV. Members of Alvotech’s management team will be... Read More

Alvotech will manufacture its high-concentration interchangeable biosimilar to Humira ® (adalimumab) for Quallent Pharmaceuticals The strategic agreement is in alignment with Alvotech’s U.S. commercialization agreement with Teva Pharmaceuticals The high-concentration interchangeable biosimilar to Humira ® manufactured by Alvotech will be distributed under Quallent’s private-label REYKJAVIK, Iceland and PARSIPPANY, N.J. and... Read More

The confirmatory clinical safety and efficacy study for AVT05, biosimilar candidate to Simponi ® and Simponi Aria ® (golimumab), met its primary endpoint in patients with moderate to severe rheumatoid arthritis Alvotech is the first company to publicly announce positive topline results from a patient study evaluating a biosimilar candidate to Simponi or Simponi Aria REYKJAVIK, Iceland, April 24, 2024 (GLOBE NEWSWIRE) --... Read More

Alvotech, in agreement with Teva Pharmaceuticals, has signed an agreement with a strategic partner to bring to the U.S. market the newly FDA approved high-concentration interchangeable biosimilar to Humira ® The agreement broadens patient access and further commitment to availability of vital biologics in the U.S. and globally REYKJAVIK, Iceland, April 19, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech... Read More

SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva SELARSDI is expected to be marketed in the U.S. on or after February 21, 2025, following a settlement agreement with Johnson & Johnson, the manufacturer of Stelara SELARSDI was developed and is manufactured by Alvotech using murine cell (Sp2/0) and a continuous... Read More

REYKJAVIK, Iceland, April 03, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will host an audio call with a market update at 12:15 pm GMT / 08:15 am EDT on April 3, 2024. Anil Okay, Chief Commercial Officer, will be providing the update. Information on how to access the webcast... Read More

REYKJAVIK, Iceland, March 22, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO) (the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, has increased the Company´s share capital by an amount of one hundred and thirty thousand (USD 130,000) by issuing thirteen million (13,000,000) ordinary shares. The Company’s subsidiary, Alvotech Manco ehf.... Read More

Total Revenues in 2023 were $93.4 million, up 10% from previous year Product Revenues in 2023 were $48.7 million, compared to $24.8 million in 2022, with Q4 2023 product revenues of $18.9 million, up by 37% from the same period last year Alvotech’s Simlandi™ biosimilar to Humira ® (adalimumab) was approved in the U.S. as the first high-concentration biosimilar with interchangeable status Sales of Alvotech’s Jamteki™... Read More

REYKJAVIK, Iceland, March 05, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will release financial results for the full year 2023, after U.S. markets close on Wednesday, March 20, 2024. Following the release, Alvotech will conduct a conference call for analysts on Thursday, March... Read More

REYKJAVIK, Iceland, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that Christina Siniscalchi will join its corporate leadership team as interim Chief Quality Officer. Christina succeeds Sandra Casaca, who is leaving the company as a part of other organizational changes.... Read More

REYKJAVIK, Iceland, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it has accepted an offer from investors (the “Investors”) for the sale of 10,127,132 of its ordinary shares, for an approximate value of USD 166 million, par value USD 0.01 per share (the “Shares”), at a... Read More

SIMLANDI is the first citrate-free, high-concentration biosimilar to be designated interchangeable to Humira in the U.S. SIMLANDI is the first biosimilar approval under the strategic partnership between Alvotech and Teva in the U.S. market SIMLANDI will qualify for interchangeable exclusivity in the U.S. for some concentration strengths REYKJAVIK, Iceland and PARSIPPANY, N.J., Feb. 24, 2024 (GLOBE NEWSWIRE) - - Alvotech... Read More

REYKJAVIK, Iceland, Feb. 15, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it has reached settlement agreements with Johnson & Johnson in Japan, Canada and in the European Economic Area (EEA) for AVT04, a biosimilar to Stelara ® (ustekinumab). Regulatory approval for AVT04 in these... Read More

The study, which assessed the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia ® in healthy adult subjects, met its primary endpoints Prolia ® and Xgeva ® (denosumab) are indicated for the treatment of bone disease REYKJAVIK, Iceland, Jan. 29, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients... Read More

REYKJAVIK, Iceland, Jan. 19, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the reinspection of Alvotech’s facility in Iceland by the U.S. Food and Drug Administration (FDA) which started on January 10, 2024, has been concluded. Following the FDA inspection, Alvotech received a form... Read More

Marketing authorization issued in European Economic Area for Uzpruvo ® , the first biosimilar to Stelara ® , a biologic therapy within gastroenterology, dermatology, and rheumatology Authorization paves way for biosimilar competition in the approximately €2.5 billion (US$2.7 billion) EU ustekinumab market as soon as possible after expiry of intellectual-property rights in July 2024 Approval for the Uzpruvo biosimilar is... Read More

The confirmatory clinical, safety and efficacy study for AVT06, biosimilar candidate to Eylea ® (aflibercept) met its primary endpoint in patients with neovascular (wet) Age-related Macular Degeneration (AMD) REYKJAVIK, Iceland, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced... Read More

REYKJAVIK, Iceland, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive top-line results from a pharmacokinetic study for AVT05, a biosimilar candidate to Simponi ® and Simponi Aria ® (golimumab). The study, which assessed the pharmacokinetics, safety, and tolerability of... Read More

Product revenue for the nine months of 2023 increased to $29.8 million, compared to $11.1 million for the same period in 2022 Marketing authorization was received for AVT04 in Canada and Japan, the first for a biosimilar to Stelara ® (ustekinumab) The European Medicines Agency proposed market authorization for AVT04 in the 30 member states of the European Economic Area, pending a final decision by the European Commission... Read More

REYKJAVIK, ICELAND, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will release financial results for the first nine months of 2023, after U.S. markets close on Tuesday, November 28, 2023. Following the release, Alvotech will conduct a business update conference call for... Read More

Pr Jamteki TM is the second biosimilar developed under this partnership that receives marketing authorization in Canada. REYKJAVIK, Iceland and BOUCHERVILLE, Quebec, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and JAMP Pharma Group (“ JAMP Pharma ”), a Canadian owned pharmaceutical... Read More

CHMP positive opinion in the European Economic Area for first biosimilar to Stelara, a biologic therapy within gastroenterology, dermatology and rheumatology Positive CHMP opinion for Uzpruvo biosimilar is based on comprehensive package comprising analytical, non-clinical and clinical similarity data, including AVT04-GL-301 study for pharmacokinetic similarity in healthy subjects and confirmatory comparative efficacy and... Read More

REYKJAVIK, Iceland, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in the Jefferies London Healthcare Conference taking place in London on November 14-16, 2023. Alvotech’s presentation is scheduled on Wednesday, November 15, 2023 at 1:00 pm GMT. A webcast of... Read More

REYKJAVIK, Iceland, Oct. 12, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT04, a biosimilar candidate to Stelara ® (ustekinumab). As... Read More

PISCATAWAY, N.J. & REYKJAVIK, Iceland / Oct 03, 2023 / Business Wire / Kashiv Biosciences LLC (“Kashiv”), a fully integrated biopharmaceutical company, and Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that they have entered into an exclusive licensing agreement for ADL018 (also called AVT23), a proposed... Read More

REYKJAVIK, Iceland and PISCATAWAY, N.J., Oct. 03, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Kashiv Biosciences LLC (“Kashiv”), a fully integrated biopharmaceutical company, today announced that they have entered into an exclusive licensing agreement for AVT23 (also called ADL018), a proposed... Read More

REYKJAVIK, Iceland, Sept. 25, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that its commercialization partner in Japan, Fuji Pharma Co., Ltd. (“Fuji”), has received marketing approval for AVT04 (ustekinumab), a biosimilar to Stelara ® , from the Japanese Ministry of Health, Labor and... Read More

REYKJAVIK, Iceland, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has accepted Alvotech’s resubmitted Biologics License Application (BLA) for AVT02, a high-concentration, interchangeable biosimilar candidate to... Read More

REYKJAVIK, Iceland, Sept. 05, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO, the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that Faysal Kalmoua has been appointed Alvotech’s Chief Operating Officer and Hafrun Fridriksdottir is stepping down following resubmission of the Biologics License Application (BLA) for AVT02,... Read More

Product revenue for the first six months of 2023 increased to $22.7 million, compared to $3.9 million for the same period in 2022 Investors, including Teva Pharmaceuticals, subscribed to Alvotech’s subordinated convertible bonds for an aggregate amount of $140 million in July 2023 Expanded its existing commercialization partnerships with Teva Pharmaceuticals for the US and with Advanz Pharma for Europe Settlement reached... Read More

REYKJAVIK, Iceland and DUBAI, United Arab Emirates, Aug. 29, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO) and Bioventure, a wholly owned subsidiary of GlobalOne Healthcare Holding LLC, today announced that the Egyptian Drug Authority (EDA) has approved the manufacturing and distribution of AVT02 (adalimumab) a biosimilar for Humira ® , which is commonly indicated for the treatment of rheumatoid arthritis and several... Read More

REYKJAVIK, Iceland, Aug. 22, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will release financial results for the first six months of 2023, after U.S. markets close on Wednesday, August 30, 2023. Following the release, Alvotech will conduct a business update conference call for... Read More

REYKJAVIK, Iceland, July 31, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the completion of a private placement, in an overseas directed offering directed solely into Iceland to professional clients or eligible counterparties, of subordinated convertible bonds denominated in Icelandic... Read More

REYKJAVIK, Iceland, June 28, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s second Biologics License Application (BLA) for AVT02, a high-concentration biosimilar candidate for Humira... Read More

According to the settlement agreement, AVT04 (ustekinumab) can be marketed in the US, subject to regulatory approval, no later than February 21, 2025 REYKJAVIK, Iceland and TEL AVIV, Israel and PARSIPPANY, N.J., June 12, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, Inc., a... Read More

REYKJAVIK, Iceland, May 31, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in the Jefferies Healthcare Conference in New York on June 7, 2023. Alvotech will present and host investor and business meetings at the conference. Anil Okay, Chief Commercial Officer is... Read More

Advanz Pharma secures exclusive rights from Alvotech to commercialize five proposed biosimilars in Europe The agreement includes proposed biosimilars to Simponi ® (golimumab), Entyvio ® (vedolizumab) and three additional early-stage undisclosed biosimilar candidates Advanz Pharma will leverage its existing specialty and hospital capabilities in Europe to ensure successful market registration, commercialization, and patient... Read More

Revenue for the first three months of 2023 increased to $15.9 million, compared to $0.8 million for the same period in 2022 Confirmatory patient study for AVT05, a proposed biosimilar for Simponi ® and Simponi Aria ® (golimumab) initiated, marking the fifth internally developed portfolio candidate to be dosed in a patient study Satisfactory outcome of facility reinspection remains the key requirement for U.S. approval of... Read More

REYKJAVIK, Iceland, May 17, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in the Morgan Stanley Annual Sustainable Finance Summit on May 22, 2023. Alvotech is scheduled to hold a fireside chat on May 22, 2023 at 10:15 am ET and will host investor meetings at the... Read More

Alvotech’s global workforce is now evenly split between females and males, and the unexplained gender pay gap has been reduced to 1.6% from 5.2% in December 2020 Alvotech’s Equality Policy, which is based on Icelandic law, has been implemented for the workforce globally REYKJAVIK, Iceland, May 15, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of... Read More

Polifarma will commercialize AVT06, a proposed biosimilar to Eylea ® (aflibercept), in Turkey REYKJAVIK, Iceland, May 10, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it has entered into an exclusive agreement with Polifarma Ilac San. ve tic. A.S. (“Polifarma”) for the... Read More

The clinical study will compare AVT05 and Simponi ® in patients with moderate to severe rheumatoid arthritis REYKJAVIK, Iceland, May 04, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today the initiation of Alvotech’s confirmatory patient study for AVT05, a biosimilar candidate to Simponi ®... Read More

REYKJAVIK, Iceland, May 03, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will release financial results for the first quarter ended March 31, 2023, after U.S. markets close on Thursday, May 18, 2023. Following the release, Alvotech will conduct a business update conference call... Read More

REYKJAVIK, Iceland, April 19, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced changes to the company’s Quality unit. Sandra Casaca has been appointed Chief Quality Officer of Alvotech and Sarah Tanksley will be joining the Board of Directors of Alvotech hf., the operating entity for... Read More

REYKJAVIK, Iceland, April 14, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT02, a high-concentration biosimilar candidate for Humira ®... Read More

REYKJAVIK, Iceland, March 28, 2023 (GLOBE NEWSWIRE) -- Alvotech (Nasdaq: ALVO) (the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced an update to the Company’s Corporate Sustainability framework, including the release of key environmental, social and governance (“ESG”) indicators for 2022. “As part of our commitment to improve... Read More

Alvotech to present two posters related to pharmacokinetics and confirmatory clinical studies for AVT04 (ustekinumab), a proposed biosimilar to Stelara ® Marketing applications for AVT04 have been submitted in major markets including U.S. and Europe REYKJAVIK, Iceland, March 17, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines... Read More

Full year 2022 total revenue, including other income, increased by 114% to $85.0 million, compared to $39.7 million in 2021, driven by both milestone revenue and product revenue from commercialization of AVT02, a biosimilar to Humira ® , in 17 countries Three biosimilar candidates, AVT03 (Prolia ® /Xgeva ® ), AVT06 (Eylea ® ) and AVT05 (Simponi ® /Simponi Aria ® ), advanced into clinical development in 2022 Marketing... Read More

REYKJAVIK, Iceland, Feb. 28, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will release financial results for full year 2022, after U.S. markets close on Wednesday, March 1, 2023. Following the release, Alvotech will conduct a business update conference call with the investment... Read More

REYKJAVIK, Iceland, Feb. 10, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today the completion of the equity transaction announced on January 23, 2023 (the “Private Share Placement”) with the transfer to the counterparties of a total of 11,834,061 treasury shares previously held by Alvotech’s... Read More

Partners Alvotech and STADA have marketing authorization application (MAA) for ustekinumab accepted for filing by the European Medicines Agency (EMA) EMA opinion on AVT04 could come as soon as the second half of 2023 Reference product Stelara ® (ustekinumab) is prescribed to treat a variety of inflammatory conditions REYKJAVIK, Iceland and BAD VILBEL, Germany, Feb. 09, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a... Read More

Advanz Pharma will commercialize AVT23, a proposed biosimilar to Xolair ® (omalizumab) in the European Economic Area, UK, Switzerland, Canada, Australia, and New Zealand REYKJAVIK, Iceland, Feb. 06, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it has entered into an exclusive... Read More

AVT02 as Simlandi™ is the first biosimilar approved under the strategic partnership between Alvotech and Bioventure REYKJAVIK, Iceland and DUBAI, United Arab Emirates, Jan. 24, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO) and Bioventure , a wholly owned subsidiary of GlobalOne Healthcare Holding LLC (“GHH”), the healthcare division of Yas Holding LLC, today announced that the Saudi Food & Drug Authority (“SFDA”) has... Read More

REYKJAVIK, Iceland, Jan. 23, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the completion of a private placement of approximately $137 million, at current exchange rates, of its ordinary shares, par value $0.01 per share, (the “Shares”) at a purchase price of $11.57 per Share at current... Read More

REYKJAVIK, Iceland and TOKYO, Jan. 13, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Japanese pharmaceutical company Fuji Pharma Co., Ltd. (“Fuji”, Tokyo Stock Exchange: 4554) have decided to expand their existing exclusive commercialization partnership covering Japan, by adding a new undisclosed... Read More

REYKJAVIK, Iceland, Jan. 11, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today the initiation of a pharmacokinetic study for AVT05, a biosimilar candidate to Simponi ® and Simponi Aria ® (golimumab). The study will assess the pharmacokinetics, safety, and tolerability of AVT05 compared to... Read More

The U.S. Food and Drug Administration’s (FDA) regulatory review is anticipated to be completed in the second half of 2023 Stelara ® (ustekinumab) is prescribed to treat a variety of inflammatory conditions REYKJAVIK, Iceland and PARSIPPANY, N.J., Jan. 06, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide,... Read More

U.S. Food and Drug Administration (FDA) has confirmed that the goal date for an approval decision on Alvotech’s license application for AVT02 is April 13, 2023 FDA has completed review of Alvotech’s application of AVT02 as an interchangeable to high-concentration of Humira ® and confirmed that the data provided are sufficient to support a determination of interchangeability; approval requires satisfactory outcome of upcoming... Read More

Reference is made to the announcement issued earlier today about the completion of a private placement of subordinated convertible bonds. The aggregate principal amount is approximately US$70 million, instead of US$59.7 million. Please see correction below. Alvotech Completes $70 Million Private Placement REYKJAVIK, Iceland, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in... Read More

REYKJAVIK, Iceland, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced completion of a private placement of approximately US$59.7 million, at current exchange rates, of subordinated convertible bonds (the “Bonds”), convertible into new fully paid ordinary shares of Alvotech.... Read More