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.
Agency's final rule defines protein based on size of amino acid sequence, irrespective of method of manufacture, saying this 'bright-line rule' provides regulatory certainty.