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FDA Classifies Insulin as Biologic; Biosimilar Insulin Applications Accepted Beginning March 23, 2020

On February 21, the FDA published a final rule in the Federal Register that implemented a requirement of the BPCIA, transitioning insulin, and some other products such as human growth hormone (somatropin), pancrelipase, chorionic gonadotropin, follitropinalfa, and menotropins, from regulation as small molecule drugs to biologics.  With respect to insulin,…

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FDA Issues Final Definition for “Biological Product”

The FDA recently issued a final rule regarding the definition of “biological product,” amending its previous definition.  The statutory definition of “biological product” included “protein (except any chemically synthesized polypeptide),” but this past December Congress removed the parenthetical excluding “any chemically synthesized polypeptide.”  Now, the FDA has announced that it…

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Litigation Update: Genentech’s Motion to Dismiss Amgen’s Counterclaims Denied in Avastin Biosimilar Litigation

On February 11, 2020, in the Biogen v. Amgen BPCIA litigation regarding MVASI (bevacizumab-awwb), Amgen’s biosimilar of AVASTIN, Judge Colm Connolly of the Delaware District Court denied most of Genentech’s motion to dismiss Amgen’s affirmative defenses and counterclaims.  Amgen had pled counterclaims seeking declaratory judgments that the asserted patents are…

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Amgen Sues Pfizer Over Proposed Neulasta Biosimilar

On February 11, 2020, Amgen sued Pfizer and its affiliate Hospira for patent infringement based on their proposed biosimilar of NEULASTA (pegfilgrastim).  Pegfilgrastim is indicated for decreasing the incidence of infection in patients receiving myelosuppressive chemotherapy.  In the complaint, Amgen alleges that Hospira’s aBLA infringes U.S. Patent No. 8,273,707 (“the…

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Merck Transfers Biosimilars and Other Products to Spinoff Company

Last week, Merck announced its intention to spin-off products from its Women’s Health, legacy brands, and biosimilars businesses into a new, yet-to-be-named, independent, publicly traded company.  According to Merck, “NewCo will pursue global leadership and focused, sustainable growth in Women’s Health led by the growing and patent-protected NEXPLANON (etonogestrel implant)…

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