FDA advisers recommend approval of Celltrion’s infliximab biosimilar

Biosimilars/News | Posted 19/02/2016 post-comment0 Post your comment

US Food and Drug Administration’s (FDA) advisers have voted to recommend the approval of Celltrion’s biosimilar version of Johnson & Johnson and Merck’s arthritis treatment Remicade (infliximab).

Review committee V15a16

Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases, such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis.

At their meeting on 9 February 2016, advisers from FDA’s Arthritis Advisory Committee voted 21–3 in favour of the recommendation to approve Celltrion’s infliximab biosimilar (CT-P13) in all indications of the originator product (Remicade).

Celltrion presented evidence that the product was ‘highly similar’ and that there were ‘no clinically meaningful differences’ between CT-P13 and Remicade in rheumatoid arthritis and ankylosing spondylitis. In addition, after considering extensive data provided by Celltrion, the advisers also recommended approving the biosimilar in the extrapolated indications of psoriatic arthritis, Crohn’s disease, ulcerative colitis and psoriasis.

Although FDA is not obliged to follow the recommendations of its advisers, it commonly does, and the agency’s decision is anticipated in April 2016. If approved by FDA the biosimilar would be the first monoclonal antibody biosimilar to be approved in the US, and Pfizer would assume commercialization rights for the biosimilar in the US under the proposed brand name, Inflectra. Hospira, now a Pfizer company, entered into a business cooperation agreement with Celltrion in 2009 for several biosimilar products including a potential biosimilar to Remicade (infliximab).

Remicade had worldwide sales of US$9.3 billion in 2014, making it the world’s best-selling medicine and a lucrative target for biosimilars developers. Although the patents on Remicade expired in Europe in February 2015, they are only set to expire in the US in September 2018 [1].

South Korean biotechnology company Celltrion submitted its biosimilar application for CT-P13 to FDA back in August 2014 [2]. The company has already obtained approval for its infliximab biosimilar from over 50 countries worldwide, including most of the advanced regulatory agencies including Canada, Europe and Japan.

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1.  GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 19]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries
2.  GaBI Online - Generics and Biosimilars Initiative. FDA receives application for monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 19]. Available from: www.gabionline.net/Biosimilars/News/FDA-receives-application-for-monoclonal-antibody-biosimilar

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Source: Celltrion,USFDA

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