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Celltrion/Pfizer Inflectra Second US Biosimilar; Many Firsts

 
• By Donna Young

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.

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.

The companies have remained mum on Inflectra's pricing – with Pfizer telling Scrip in a statement it "cannot comment on our future development and commercialization strategies" for the product, which...

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