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Teva Receives Approval for First Ophthalmology Biosimilar in Europe

Earlier this week, Teva Pharmaceutical Industries Ltd. (Teva) announced that the UK Medicines & Healthcare Regulatory Agency (MHRA) approved ONGAVIA, a ranibizumab biosimilar referencing Genentech’s LUCENTIS.  Ranibizumab inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. The United Kingdom is…

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Viatris and Biocon Biologics Launch Bevacizumab Biosimilar ABEVMY in Canada

On May 19, 2022, Viatris Inc. and Biocon Biologics Ltd. announced that ABEVMY, a bevacizumab biosimilar, is now available in Canada.  According to the press release, Viatris and Biocon Biologics co-developed ABEVMY, which references Roche’s AVASTIN (bevacizumab), a recombinant humanized monoclonal antibody that selectively binds to human vascular endothelial growth…

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Alvotech Announces Positive Results from a Pharmacokinetic Similarity Study for Ustekinumab Biosimilar

On May 16, 2022, Alvotech Holdings S.A. (“Alvotech”) announced positive top-line results from a pharmacokinetic (PK) study for AVT04, Alvotech’s proposed biosimilar to STELARA® (ustekinumab).  Alvotech notes that the study used “a single dose, 3-arm, parallel design to compare pharmacokinetics, safety, tolerability, and immunogenicity of a single 45mg/0.5mL subcutaneous dose…

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Brian Burgess to speak at FDLI Annual Conference

The annual Food & Drug Law (FDLI) conference will be held on June 14-15, bringing together experts from the federal government, industry, the private bar, non-profit, patient and consumer advocates, consulting organizations, and academia to address complex legal, regulatory, compliance, and policy issues facing the FDA-regulated industry.  Goodwin is a…

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Q1 2022 Earnings Roundup: Biologics and Biosimilars Update

Below are some highlights from first quarter 2022 earnings reports recently released by biologics and biosimilars companies: Biogen:  Last week, Biogen reported total quarterly revenues of $2,532 million, and biosimilar revenue of $194 million decreased 5% versus the prior year.  As reflected by the assumption in the Company’s Full Year…

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Formycon AG Acquires Biosimilar Assets Ustekinumab and Ranibuzumab

On May 10, 2022, Formycon AG (“Formycon”) and ATHOS KG (“ATHOS”) announced that they have closed a transaction regarding the biosimilar assets FYB201 (ustekinumab) and FYB202 (ranibuzumab).  According to the press release, Formycon has acquired 100% of the rights in FYB202, a biosimilar candidate for STELARA®, and ATHOS’s 50% stake…

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Pfizer Files Lawsuit in Australia to Halt Sales of BRENZYS (etanercept)

Last week Pfizer filed a lawsuit in a federal court of Australia against respondents Samsung Bioepis, Merck, Sharp & Dohme, Organon, and Arrow, to halt sales of their biosimilar BRENZYS (etanercept).  Pfizer alleges that the respondents infringe Australian Patent No. 2005280034, titled “Production of polypeptides,” with claims directed to cell…

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Henlius and Eurofarma Entered into a License Agreement for Henlius' 3 Products in Latin America

Shanghai Henlius Biotech, Inc. (“Henlius”) announced this week that it has entered into a license and collaboration agreement with Eurofarma Laboratórios SA (“Eurofarma”), a Brazilian multinational biopharmaceutical company, for the development, manufacturing and commercialization of three biosimilar products in 16 Latin American countries. The three products are HANLIKANG® (rituximab), HANQUYOU®…

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