Celltrion’s biosimilar for J&J’s arthritis drug gets UF FDA okay

pharmafile | April 6, 2016 | News story | Manufacturing and Production, Research and Development  

Korea-based Celltrion (Kosdaq: 068270) has received US regulatory approval for its biosimilar version of the arthritis drug marketed by Johnson & Johnson (NYSE: JNJ) and Merck & Co (NYSE: MRK).

The biosimilar copy is expected to be priced about 20% to 30% lower than Remicade in the US market, Celltrion has said.

The US Food and Drug Administration (FDA) approved Inflectra (infliximab-dyyb), a biosimilar copy of J&J and Merck’s Remicade (infliximab).

HyoungKi Kim, Chief Executive of, Celltrion says: “As one of the first companies to navigate the biosimilar approval pathway with the FDA, we believe this approval will be an essential step in helping to clarify the application process for these critical medicines. Our experience with biosimilars outside the US suggests that Inflectra provides patients with both therapeutic and financial benefits, and we hope to see the same value provided in the US.”

The biosimilar will be marketed in the US by Pfizer (NYSE: PFE) to treat several indications including rheumatoid arthritis. The approval of Inflectra marks the first authorisation of a biosimilar of Remicade in the US and the second approval of any biosimilar in the country, following the clearance of Novartis’ (VTX: NOVN) Zarxio last year.

Remicade, first approved in 1998, generated sales of $6.56 billion last year for J&J.

Inflectra is currently approved in 71 countries across the world.

Celltrion developed Inflectra under the terms of an agreement forged with Hospira in 2009, with Pfizer obtaining rights to the therapy following its acquisition of the latter drugmaker last year.

Anjali Shukla

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