Search Results for: "amgen v apotex"

Biocon and Mylan Team Up for Biosimilar Regulatory Filings

Biocon, a prominent Indian biopharma company, entered into a partnership with Mylan in 2009 for joint research and development of biosimilars. That partnership now appears to be yielding results.  The companies expect to submit regulatory filings in both the U.S. and EU 2016: trastuzumab, pegfilgrastim, adalimumab, and insulin glargine. As Big…

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Big Day for Celltrion’s Infliximab Product

Yesterday, the FDA’s Advisory Committee overwhelmingly supported approval of Celltrion’s infliximab product, which is a biosimilar for Janssen’s Remicade product. At the District Court status conference in Janssen v. Celltrion, which followed the Advisory Committee vote, Celltrion’s counsel said that Celltrion is expecting FDA approval in about four to eight…

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Busy Month Ahead for BPCIA Interpretation Questions

February will be a busy month for pending BPCIA cases, with activity on the horizon in Amgen v. Apotex, Amgen v. Hospira, and Janssen v. Celltrion: Amgen v. Apotex (Fed. Cir.) As we covered previously, Apotex appealed the district court’s order granting Amgen a preliminary injunction in Amgen v. Apotex. Apotex requested an expedited briefing…

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