Pfizer Hones Biosimilars Approach For Individual Countries
The company has biosimilars of Rituxan, Herceptin and Remicade in clinical trials and a biosimilar to Humira is about to enter Phase I; Pfizer is pursuing the biosimilar pathway for all of its candidates.
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Korea’s Celltrion said it is on path to a new Phase III trial design of a biosimilar of Roche’s Rituxan after presenting positive Phase I trial data in San Diego in late October.
If approved in Europe this year, as expected, Celltrion/Hospira’s biosimilar infliximab will provide a compelling test of whether and how quickly budgetary pressures can override physician caution. It will also set the stage for the $70 billion worth of copycat antibodies in development.
IMS Health official says the biologic and biosimilar markets are looming growth areas as small-molecule opportunities decline, but questions about the abbreviated biosimilar pathway linger.