Pfizer Eliminates Roadblock To Remicade Biosimilar Launch
October launch seems more certain after district court rules patent covering the antibody is invalid; litigation continues over cell culture media patent that expires in 2027.
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A look at the status of suits involving Remicade, Neulasta, Epogen and Enbrel proposed biosimilars; Humira patents are being challenged in inter partes review proceedings rather than district court.
Pfizer and Celltrion agreed not to market Inflectra, their biosimilar to Janssen's blockbuster TNF-inhibitor, before mid-September barring certain circumstances.
Industry reps are glad that Birenbaum, who was the chief cannabis policy advisor to the governors of New York and Rhode Island, was given a prominent role at FDA that could spur regulatory action.