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Second biosimilar anti-TNF nears EU market

SamsungBioepis' version of Enbrel recommended for approval by the CHMP

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The tumour necrosis factor (TNF) inhibitor class includes some of the biggest selling biologic drugs on the market - and could see the entry of additional biosimilars in the coming months.

A few days ago, Samsung Bioepis moved a step closer to the EU market for Benepali (SB4) - a biosimilar version of Amgen's anti-TNF Enbrel (etanercept) - after the drug was given a positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). 

Benepali's recommendation sets up formal approval within 60 days, which would give the EU a second biosimilar in the anti-TNF category after Celltrion and Hospira's Inflectra/Remsima, which were approved last year as the first biosimilar versions of Janssen/MSD's $10bn-a-year Remicade (infliximab).

Samsung Bioepis - a joint venture between Samsung and Biogen - said that approval would give patients in Europe access to the first subcutaneously-administered anti-TNF biosimilar. The company has a partnership with Merck & Co for its biosimilar portfolio, which also includes a Remicade biosimilar.

Benepali has been endorsed by the CHMP for the treatment of moderate to severe rheumatoid arthritis, psoriatic arthritis, non-radiographic axial spondyloarthritis, and plaque psoriasis in the EU. It was approved in South Korea as Brenzys in September.

… as Amgen files ABP 501 in US

The positive opinion for Samsung Bioepis' drug was swiftly followed by the news that Amgen has submitted for US FDA approval of its biosimilar version of AbbVie's Humira (adalimumab) - currently the top-selling drug in the world with sales of more than $13bn last year. 

If all goes according to plan the biosimilar - known as ABP 501 - could be the first anti-TNF biosimilar with a US approval by the third quarter of 2016, unless Celltrion manages to overcome regulatory and potentially patent issues holding up its Remsima application there. 

Amgen will also have some intellectual property hurdles to vault, given that AbbVie maintains it has patent protection in the US until 2022.

Given that Humira, Remicade and Enbrel represent three of the top five-selling drugs worldwide - with collective sales of more than $30bn in 2014 - the entry of the biosimilars will provide a big opportunity for health systems to curb costs.

Initial uptake for Celltrion and Hospira's Remicade biosimilars in Europe - where patents on the drug have already expired - are reported to be buoyant since they reached the market in February.

Article by
Phil Taylor

2nd December 2015

From: Sales, Regulatory

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