FDA Approves 5th Biosimilar, 2nd for Remicade

Regulatory NewsRegulatory News | 21 April 2017 |  By 

The US Food and Drug Administration (FDA) on Friday announced its fifth biosimilar approval: Samsung Bioepis’ Renflexis (infliximab-abda), an intravenous infusion for multiple indications.

This is the second FDA approval for a biosimilar to Johnson & Johnson’s Remicade (the first was Pfizer and Celltrion’s Inflectra (infliximab-dyyb)), though both Inflectra and Renflexis have been approved as biosimilars but not as interchangeable biosimilars. The shift in the cost of Remicade, with two competitors hitting the market now, could be a bellwether for how biosimilar savings are calculated.

Also on Friday, the European Medicines Agency recommended three biosimilars for approval, including Sandoz's Erelzi (etanercept), and its Rixathon (rituximab) and Riximyo (rituximab).

The most recent prior biosimilar US approval was for Amgen's Amjevita (adalimumab-atto), which was the first biosimilar version of AbbVie's best-selling biologic Humira. The third was Sandoz’s biosimilar to Amgen’s blockbuster Enbrel, known as Erelzi (etanercept-szzs), and the first biosimilar approved was Sandoz’s Zarxio (filgrastim-sndz), biosimilar to Amgen's Neupogen.


© 2022 Regulatory Affairs Professionals Society.

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