Division of Novartis AG
Latest From Sandoz Inc.
A biosimilar version of Amgen’s Neulasta has yet to be approved in the EU but one such product is in the later stages of review at the European Medicines Agency.
US Federal Circuit finds in Amgen v. Sandoz that the BPCIA preempts innovator companies from seeking penalties under state law against a biosimilar sponsor that does not engage in the 'patent dance.'
Ixifi (infliximab-qbtx), which references Janssen's Remicade, marks first US approval of a biosimilar developed entirely by Pfizer; big pharma says it is not currently planning to launch Ixifi because it remains "committed" to marketing Celltrion's Inflectra.
USV has joined the list of firms seeking clearance for biosimilar pegfilgrastim in Europe. Managing director Prashant Tewari says the company is “well geared” to address potential price competition and maintains that biosimilarity of USV’s pegfilgrastim with the innovator product has been established “satisfactorily”.
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Peter Goldschmidt, Pres.
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Anthony Maffia, III, VP, Regulatory Affairs
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