Australian approval for infliximab biosimilar

Biosimilars/General | Posted 21/08/2015 post-comment0 Post your comment

South Korean biotechnology company Celltrion announced on 10 August 2015 that its partner Hospira had gained approval from Australia’s drug regulator, the Therapeutic Goods Administration (TGA), for the infliximab biosimilar Inflectra.

Approved V13G05

Inflectra has been approved by the TGA for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, adult and paediatric Crohn’s disease, refractory fistulising Crohn's disease, adult and paediatric ulcerative colitis and plaque psoriasis.

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 in September 2013 [1]. Celltrion has also gained approval to sell Remsima in Canada, Japan and Korea, as well as in 13 out of the 22 countries in South America [2]. In fact, Celltrion has already obtained approval for Remsima from over 50 countries worldwide.

In Europe, as well as in Japan and Korea, the biosimilar was approved for all indications of the originator product Remicade. However, in Canada extrapolation from autoimmune arthritis to inflammatory bowel disease (IBD) was not granted [3].

In August 2014, Celltrion announced that it had completed the filing procedure to obtain US Food and Drug Administration approval for its infliximab biosimilar [4].

Hospira will take charge of the drug’s marketing, distribution and sales in Australia. The biosimilar is expected to gain a strong market share in the country, due to the price sensitivity of the Australian pharmaceutical market. With a number of originator biologicals (primarily monoclonal antibody therapies) set to come off patent, the Federal Government in Australia estimates that increased use of biosimilars will deliver AU$880 million in PBS savings over the next five years.

Editor’s comment
It should be noted that similar biotherapeutic products approved in South America 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.

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1. GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 21]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Venezuelan approval for Celltrion’s Remsima []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 21]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. Subsequent entry biologics approved in Canada []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 21]. Available from:
4. GaBI Online - Generics and Biosimilars Initiative. FDA receives application for monoclonal antibody biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 21]. Available from:

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Source: Hospira, Korea Herald

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