FDA panel backs Celltrion biosimilar of Remicade

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Advisors to the US Food and Drug Administration have given their blessing to Celltrion and partner Pfizer’s biosimilar of Johnson & Johnson’s blockbuster Remicade.

The agency’s Arthritis Advisory Committee recommended approval of all indications of Celltrion’s version of Remicade (infliximab) by a vote of 21-3. The drug, which will be marketed as Inflectra by Pfizer, is the first biosimilar monoclonal antibody (mAb) to be considered by the FDA (approval is expected in April) and will be available for a variety of serious autoimmune diseases, including Crohn’s disease, ulcerative colitis and rheumatoid arthritis.

The Committee concluded that the Celltrion version is “highly similar” to Remicade, “notwithstanding minor differences in clinically inactive components”. It also noted that there were “no clinically meaningful differences…in terms of the safety, purity, and potency of the product” in the studied indications of RA and ankylosing spondylitis.

HyoungKi Kim, Celltrion’s chief executive, said “we have experienced the benefits of biosimilars outside of the USA, including Europe, and are looking forward to advancing our development programme with the FDA”. He added that we are in “an age where biosimilar mAbs are globally recognised as innovative, high quality biologics that are highly similar in both efficacy and safety to their originator products, but are more affordable”.

Sumant Ramachandra, head of R&D at Pfizer’s Global Established Pharma unit, said “biosimilars represent an exciting opportunity to expand patient access to important treatments, and we are proud to be at the forefront of helping shape and prepare the US market for these therapies”.