The US Food and Drug Administration (FDA) announced on 5 April 2016 that it had approved the country’s second biosimilar Inflectra (infliximab).
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.
Inflectra is produced by South Korean biologicals specialist Celltrion and is a biosimilar of Johnson & Johnson and Merck’s Remicade (infliximab). The patents on Remicade expired in Europe in February 2015 and will expire in the US in September 2018 [1].
FDA has approved Inflectra for the same indications as Remicade, i.e. ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis. Inflectra is the first biosimilar monoclonal antibody medication to receive approval in the US.
FDA approval was based on the totality of evidence presented at the Arthritis Advisory Committee meeting on 9 February 2016, demonstrating no clinically meaningful differences between Inflectra and US-licensed Remicade in terms of the safety, purity and potency of the product. Advisers from the 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) [2].
FDA has also designated a placeholder non-proprietary name for Inflectra – infliximab- dyyb, as it did for the first biosimilar approved in the US, Zarxio – filgrastim-sndz. The agency has, however, made it clear that it has not yet made a final decision on whether biosimilars will receive the same International Non-proprietary Name (INN) as their reference biologicals or unique names.
Celltrion gained European approval for the world’s first monoclonal antibody biosimilar Remsima/Inflectra (infliximab) as part of its collaboration with US-based generics major Hospira [3]. Since then, Celltrion has also gained approval for Remsima in South Korea [4], Colombia [5], Japan [6] and Canada [7]. Brazil also approved Remsima, as its first follow-on biological medicine, through its pathway for follow-on biological products, in April 2015 [8].
Inflectra is currently approved in 71 countries across the globe and will be commercialized by Pfizer in the US.
Editor’s comment
It should be noted that ‘follow-on biologicals’ approved in Brazil might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the EU. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.
Related articles
Non-originator infliximab approved in Russia
Infliximab SEB launched in Canada
Biosimilars of infliximab
References
1. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 8]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-etanercept-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. FDA advisers recommend approval of Celltrion’s infliximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 8]. Available from: www.gabionline.net/Biosimilars/News/FDA-advisers-recommend-approval-of-Celltrion-s-infliximab-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 8]. Available from: www.gabionline.net/Biosimilars/News/EC-approves-first-monoclonal-antibody-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilar monoclonal antibody approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 8]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-monoclonal-antibody-approved-in-Korea
5. GaBI Online - Generics and Biosimilars Initiative. Remsima approved in Colombia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 8]. Available from: www.gabionline.net/Biosimilars/News/Remsima-approved-in-Colombia
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilar infliximab launched in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 8]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-infliximab-launched-in-Japan
7. GaBI Online - Generics and Biosimilars Initiative. Infliximab SEB launched in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 8]. Available from: www.gabionline.net/Biosimilars/News/Infliximab-SEB-launched-in-Canada
8. GaBI Online - Generics and Biosimilars Initiative. Brazil approves first monoclonal antibody follow-on biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 8]. Available from: www.gabionline.net/Biosimilars/News/Brazil-approves-first-monoclonal-antibody-follow-on-biological
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Source: Celltrion, US FDA
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