Sandoz Enbrel Copycat Next Biosimilar To Get Panel Treatment
The FDA has elected to take Sandoz Inc.'s 351(k) application for its etanercept biosimilar, which is referenced on Amgen Inc.'s tumor necrosis factor blocker Enbrel, to an advisory committee to get its advice on whether to license the product. It's only the third biosimilar to get the expert panel treatment.
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Move over Zarxio. There's a new kid in town: Inflectra (infliximab-dyyb), which won the FDA's nod on April 5 as the first monoclonal antibody biosimilar licensed in the US, although it's going to be a while before patients have access to the new drug, since Celltrion Inc. and Pfizer Inc. said they won't put it on the market until after June 29.
For the second time, Novartis AG unit Sandoz Inc. is trying to "reap the commercial benefits" provided to biosimilar manufacturers under the Biologics Price Competition and Innovation Act (BPCIA), while seeking to avoid the obligations Congress established under the 2010 law "to protect innovators," Amgen Inc. and Roche AG charged in new court documents.
With the favorable backing by an FDA advisory panel on Feb. 9, which followed a positive review by regulators, Celltrion Inc. and its partner Hospira Inc., a unit of Pfizer Inc., are well on their way of putting the first biosimilar of a monoclonal antibody on the US market.