EC approves first monoclonal antibody biosimilar

Biosimilars/News | Posted 13/09/2013 post-comment0 Post your comment

Hospira announced on 10 September 2013 that it had received European Commission (EC) approval for its biosimilar monoclonal antibody infliximab (Inflectra), a first in Europe.

Approved V13G05

The news follows the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) positive recommendation on 28 June 2013 [1].

Inflectra has been shown to be similar to Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab). Inflectra has been approved for use in the same indications as Remicade, i.e. for the treatment of inflammatory conditions including rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis.

The biosimilar was developed by South Korean biotechnology company Celltrion, and will also be marketed by Celltrion as Remsima. Hospira’s agreement with Celltrion back in 2009 gives Hospira the rights to market Inflectra in Europe, as well as in Australia, Canada, New Zealand and the US.

Dr Stan Bukofzer, Corporate Vice President and Chief Medical Officer at Hospira, confirmed that ‘the rigorous scientific review and approval process by EMA and EC confirms that Inflectra has demonstrated similar quality, efficacy and safety to Remicade’, making it a more affordable therapeutic alternative to the originator biological Remsima.

Remicade recorded European sales of over US$2 billion in 2012, making it a lucrative target for biosimilars manufacturers. The introduction of biosimilar monoclonal antibodies in Europe is expected to deliver savings of up to Euros 20.4 billion by 2020, with the biggest savings predicted in France, Germany and the UK.

The European Generic medicines Association (EGA) welcomed the approval, stating that the news ‘reinforce[s] Europe’s leading role in biosimilar medicines’. Adding that the robust regulatory testing required by EMA, which meant that the biosimilar underwent ‘extensive testing, including phase III trials, before marketing authorization could be granted’ should ‘help to remove potential clinical obstacles to market entry’.

Hospira stated in its press release that it intends to launch Inflectra throughout Europe at the earliest opportunity taking into account any relevant patent protection. The patent on Remicade was due to expire in Europe in August 2014, but Johnson & Johnson recently gained a paediatric extension, staving off competition from biosimilars until February 2015.

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1.  GaBI Online - Generics and Biosimilars Initiative. EMA approves first monoclonal antibody biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Sep 13]. Available from:

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Source: EGA, Hospira

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