Benepali gains approval for extra indications

Biosimilars/News | Posted 13/01/2017 post-comment0 Post your comment

Samsung Bioepis, which is a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen, announced on 16 December 2016 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion for the extension of indications for its etanercept biosimilar Benepali

Clinician indications V17A13

The positive CHMP opinion has been given for the Type II variation application for the indication extension of Benepali (SB4) for the treatment of juvenile idiopathic arthritis and paediatric plaque psoriasis in patients weighing more than 62.5 kg.

Benepali was approved by the European Commission (EC) in January 2016 [1], and remains the only etanercept biosimilar approved for marketing in all 28 European Union (EU) Member States and the European Economic Area (EEA) Member States of Norway, Iceland and Liechtenstein. Benepali is being commercialized by Biogen in these markets. The indications approved in January 2016 were rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) and plaque psoriasis.

The etanercept biosimilar (SB4) from Samsung Bioepis has also been approved in Korea, Australia and Canada, where the biosimilar is being marketed by Merck, which is known as MSD outside of Canada and the US, as Brenzys. SB4 is also under review at Swissmedic and the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA).

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 13]. Available from:

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Source: Samsung Bioepis

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