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Home Industry News Amgen receives European approval for new biosimilar Amgevita

Amgen receives European approval for new biosimilar Amgevita

24th March 2017

Amgen has announced that its new biosimilar product Amgevita has been approved by the European Commission.

The biosimilar is based on the existing anti-inflammatory therapy adalimumab and has been approved across all indications for which adalimumab is currently authorised for use, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, hidradenitis suppurativa, Crohn's disease and ulcerative colitis.

It has also been approved for the treatment of certain paediatric inflammatory diseases, including Crohn's disease, plaque psoriasis, enthesitis-related arthritis and polyarticular juvenile idiopathic arthritis.

This decision was based on clinical data showing Amgevita's biosimilarity to adalimumab, including results from two phase III studies conducted in moderate to severe plaque psoriasis and rheumatoid arthritis patients.

Dr Sean Harper, executive vice-president of research and development at Amgen, said: "The approval of our first biosimilar by the European Commission is a major milestone, not just for Amgen as a company, but for the millions of patients with chronic inflammatory diseases who need alternative treatment options."

The drug was approved in the US in September 2016, where it is marketed under the brand name Amjevita.

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