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.

Related articles

Celltrion applies for Korean approval of biosimilar trastuzumab

US$67 billion worth of biosimilar patents expiring before 2020

Reference

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2013 Pro Pharma Communications International. All Rights Reserved.