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Biologics & Biosimilars Blog

Articles: 1-10 of 46

Teva and Alvotech Announce Partnership in the U.S. Biosimilar Market

USA - August 10 2020 Pharmaceutical companies Teva Pharmaceutical Industries Ltd. and Alvotech announced on Wednesday, August 5, 2020, that they will be entering into an…

Litigation on Amgen’s Biosimilar to Avastin Settles on Heels of Amgen Procedural Victory at Federal Circuit

USA - July 13 2020 We have previously covered various aspects of a legal battle between Genentech and Amgen regarding Amgen’s efforts to market Mvasi, a biosimilar to…

FDA Approves Rapid-Acting Insulin

USA - July 2 2020 The FDA approved Eli Lilly’s Lyumjev™ (insulin lispro-aabc injection, 100 units/mL and 200 units/mL) last month, which is a new rapid-acting insulin…

FDA Approves First Biosimilars of 2020

USA - June 24 2020 As previously reported, the FDA had yet to approve any biosimilars in 2020 as of June 9, despite a growing pipeline. Since then, the FDA has approved…

Biosimilar Approvals Stall During COVID-19 Pandemic, But the Pipeline Grows

USA - June 8 2020 As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set to enter the U.S…

The Federal Circuit Dismisses Pfizer’s Appeal for Lack of Standing

USA - May 11 2020 Recently, the Federal Circuit Court of Appeals dismissed Pfizer Inc.’s (“Pfizer”) appeal for lack of Article III standing. Pfizer had filed an inter…

Committee for Medicinal Products for Human Use Provides Biosimilar Updates at March Meeting

European Union - April 21 2020 The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) held its monthly meeting on March 23-26, 2020. During the…

Recent Developments in Government Protection of Biosimilar Competition

USA - April 1 2020 In February, the U.S. Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) published a joint statement regarding…

2019 Ends and 2020 Begins with a Flurry of Biosimilar Activity in East Asian Markets

China - February 24 2020 A white paper released in 2019 by The Biosimilars Forum and Medicines for Europe shows the United States and Europe accounting for more than a…

Hospira Requests En Banc Review of Ruling Regarding Safe Harbor

USA - February 16 2020 On January 15, 2020, Hospira filed a petition for rehearing en banc asking the full Federal Circuit to reconsider a prior panel’s analysis of the…