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(LEAD) Samsung Bioepis biosimilar wins positive response from EU drug agency

All News 10:11 June 24, 2017

(ATTN: DELETES 7th para to clarify the product will "not" be the first autoimmune disease-related biosimilar product to be approved in Europe)

SEOUL, June 24 (Yonhap) -- Samsung Bioepis Co. said Saturday its biosimilar to treat rheumatoid arthritis won a 'positive opinion' from the European Medicines Agency, paving the way for the product's official release in the region.

The joint venture between Samsung Biologics Co. and Biogen Inc. said the biosimilar, dubbed Imraldi or SB5, received the response from the Committee for Medicinal Products for Human Use (CHMP) under the European body. The update came a year after Samsung first applied for official sales in June 2016.

The company said the committee's opinion plays a crucial role in winning the final approval to sell pharmaceutical goods in Europe.

The product will be ready for commercialization when the European Commission makes the decision.

The SB5 is a biosimilar of Humira released by U.S.-based AbbVie Inc., used for the treatment of various diseases including Crohn's disease and rheumatoid arthritis. A biosimilar is a copy of a medicine developed after the patents for the original drug have expired.

Industry sources said Humira makes up 60 percent of AbbVie's annual sales.

An official from Samsung Bioepis said the company is seeking to release the product in the United States in the near future.

(LEAD) Samsung Bioepis biosimilar wins positive response from EU drug agency - 1


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