FDA staff find Novartis' proposed biosimilar comparable to Amgen's Enbrel

In documents posted Monday to the FDA's website ahead of a July 13 advisory panel meeting, agency staff concluded that Novartis' GP2015, the company's proposed biosimilar of Amgen's Enbrel (etanercept), is "highly similar" to the reference product. Novartis' Sandoz unit is seeking to have GP2015 cleared for the five indications that Enbrel is licensed for in the US, including rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis.

Specifically, FDA reviewers noted that there were "no clinically meaningful differences" between GP2015 and Enbrel in the studied condition of plaque psoriasis, adding that the company had submitted sufficient evidence to support its claims of biosimilarity between the drugs in the other conditions for which Enbrel is approved. Amgen filed a lawsuit against Sandoz earlier this year alleging that GP2015 would potentially infringe on multiple patents covering Enbrel, which generated US sales of $5.1 billion last year.

Sandoz unit head Richard Francis last month indicated that GP2015 was among five biologics targeted by Novartis for planned global launches by 2020. In January, Samsung Bioepis announced that the European Commission approved Benepali, also known as SB4, marking the first authorisation of an Enbrel biosimilar in the region. 

Meanwhile, the same FDA advisory panel is also scheduled this week to review Amgen's proposed biosimilar of AbbVie's Humira (adalimumab), dubbed ABP 501, which agency reviewers also recently found to be "highly similar" to the reference product. Amgen is applying to have ABP 501 approved for several indications, including rheumatoid arthritis, psoriatic arthritis, Crohn's disease, ulcerative colitis and plaque psoriasis. Humira, which AbbVie claims is patent-protected in the US until at least 2022, recorded sales of more than $8 billion in the country last year.

For related analysis, see ViewPoints: How the FDA learned to stop worrying and love biosimilars. See also KOL Views: Is it a question of 'when' rather than 'if' there is a biosimilars explosion in the US market?, and to learn more about the biosimilar market, read Biosimilar Index: Tracking the Biosimilar Development Landscape

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