Remicade copy clears FDA, becomes second biosim to win approval in U.S.
- The FDA on Tuesday approved a biosimilar version of Johnson and Johnson's blockbuster inflammatory disease drug Remicade (infliximab), marking only the second time a biosimilar has been approved in the U.S.
- Developed by the Korean company Celltrion and co-marketed by Pfizer, Inflectra will carry indications for a range of inflammatory diseases including moderate-to-severe rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, and chronic severe plaque psoriasis.
- Although prevalent in Europe, biosimilars have not fully hit the U.S. market. Prior to Tuesday's approval, only Sandoz's Zarxio had been okayed in the U.S.
Importantly, Inflectra was approved as a biosimilar and not as an interchangeable product. A biosimilar designation means the drug is highly similar to Remicade, with no clinically meaningful differences in safety and efficacy. However, because the FDA did not deem it an interchangeable, Inflectra cannot be substituted for Remicade by a pharmacist without the okay of the prescribing physician.
Janssen, the J&J unit responsible for Remicade, noted this fact in a statement: "Celltrion’s infliximab-dyyb is a biosimilar but not identical to Remicade,” said Jay Siegel, head of scientific strategy and policy at Johnson & Johnson. The company also said it would defend is intellectual property rights in the event Inflectra is launched commercially before September 2018, when its patents fully expire.
Although Remicade was originally licensed nearly two decades ago, the drug still pulled in over $6 billion in global sales last year. It is one of a number of blockbuster drugs, including AbbVie's Humira and Amgen's Enbrel, facing increasing competition from biosimilar manufacturers.
Just last week, Samsung Bioepis won approval from the European Medicines Agency for its biosimilar of Remicade. However, Celltrion had already beat its Korean rival to the E.U. market by a wide margin, with its Remicade copy approved in the E.U. since 2013.
But Samsung is moving fast to develop other biosimilars. It scored the first major-market approval for an Enbrel biosimilar in January of this year when the EMA gave Benepali a green light. It is also developing a copy of Humira.
In the U.S., Inflectra will carry a boxed warning for an increased risk of serious infections, including tuberculosis, bacterial sepsis, and invasive fungal infections and others. Other adverse events, including lymphoma, have been reported with infliximab products.
Note: This post has been updated to reflect a statement from Janssen, who reached out after publication.
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