Tagged as: Biosimilars News

Global Biosimilar Development Updates

Over the past month, several drug developers announced updates regarding their biosimilar programs. Below are some highlights, in addition to the many biosimilar developments on which we have already reported: Today, December 3, 2018, Celltrion announced that the European Medicines Agency (EMA) has accepted Celltrion’s Extension Marketing Authorisation Application for…

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AbbVie and Pfizer Settle Adalimumab Biosimilar Patent Disputes

Today, AbbVie and Pfizer announced that they reached a global resolution of all intellectual property-related litigation concerning Pfizer’s proposed biosimilar adalimumab.  According to the press releases, AbbVie has granted Pfizer a non-exclusive license to AbbVie’s intellectual property relating to adalimumab in the United States and other countries.  All litigation pending between the parties…

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Coherus Plans to Launch UDENYCA (pegfilgrastim-cbqv) in U.S. in January at 33% Discount

On November 8, 2018, on its quarterly earnings call for Q3 2018 (transcript available here), Coherus BioSciences provided updates regarding its commercial launch plans for its recently approved Udenyca™ (pegfilgrastim-cbqv) biosimilar product.  President, CEO and Chairman Denny Lefler told financial analysts on the call that Udenyca™ will be available for…

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Goodwin’s Elaine Blais and Alex Valenti to host a Biosimilars Market Update Webinar

On November 6th, Goodwin’s Elaine Blais and Alex Valenti will be hosting a Biosimilars Market Update webinar, discussing key issues and recent legal and regulatory developments in the biosimilars space. Topics will include recent antitrust claims filed against biologic manufacturers, new strategies in BPCIA litigation, updates on legal developments affecting validity…

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Big Molecule Watch Editor Nick Mitrokostas to Speak at Biosimilars in the Antitrust Spotlight: Patent Litigation and Settlement Webinar

Tomorrow, October 4th, Goodwin’s Nick Mitrokostas will participate as a panelist on the Biosimilars in the Antitrust Spotlight: Patent Litigation and Settlement webinar, discussing the likely shape of settlements in patent litigation between innovator biologic companies and biosimilar aspirants, the future of non-cash forms of compensation and whether “at-risk” entry is…

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European Biosimilar Approval Updates: Adalimumab, Pegfilgrastim

In August, we reported that the Committee for Medicinal Products for Human Use (CHMP) of the  European Medicines Agency (EMA) recommended the granting of marketing authorization for three biosimilar medicines:  (1) Fujifilm Kyowa Kirin Biologics (FKB) and Mylan’s Hulio® (adalimumab), a proposed biosimilar of Humira®; (2) Accord Healthcare’s Pelgraz® (pegfilgrastim),…

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