FDA Advisory Committee Recommends Sandoz’s Biosimilar of Enbrel

The US Food and Drug Administration (FDA) Arthritis Advisory Committee has recommended approval of Sandoz’s proposed biosimilar, etanercept. Etanercept is the reference product or innovator biologic upon which the biosimilar is based is the active ingredient in Enbrel. The committee voted unanimously (20-0), in support of biosimilar etanercept for all five indications of the reference product, including rheumatoid arthritis, plaque psoriasis, psoriatic psoriasis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis. Sandoz is part of Novartis. .

The FDA seeks the advice of its advisory committees as it reviews and decides whether to approve applications although the agency does not always follow their recommendations. In December 2015, the European Medicines Agency accepted Sandoz’s marketing authorization application for its biosimilar to Amgen’s European Union-licensed Enbrel, which seeks approval for the same indications as the reference product.

GP2015, the Sandoz proposed biosimilar of Enbrel, has been studied in a global development program, which included a comparison of GP2015 and Enbrel at the analytical, non-clinical, and clinical levels, including data from four pharmacokinetic studies as well as data from a confirmatory efficacy and safety study of patients with moderate-to-severe chronic plaque psoriasis. The development program also included five non-clinical studies. The proposed indications for GP2015 are identical to the indications for Enbrel in rheumatoid arthritis, plaque psoriasis,psoriatic psoriasis, ankylosing spondylitis, and polyarticular juvenile and idiopathic arthritis.

Sandoz plans to launch five biosimilars of major oncology and immunology biologics across key geographies by 2020 and invest $1 billion as part of a 2010-2020 investment scheme in biomanufacturing facilities in Schaftenau and Kundl, Austria.The five launches will be enabled by a regulatory submissions strategy of 11 filings over a three-year period (2015-2017).

Subject to regulatory requirements and approvals, Sandoz' upcoming launches will include biosimilars of Enbrel (etanercept), Humira (adalimumab), Neulasta (pegfilgrastim), Remicade (infliximab) and Rituxan (rituximab).

Source: Novartis

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