FDA Accepts Samsung Bioepis’ BLA for a Biosimilar of Remicade

Samsung Bioepis Co., Ltd. reports the US Food and Drug Administration (FDA) has accepted for review the company's biologics license application (BLA) for SB2, a biosimilar candidate referencing Remicade (infliximab), for the treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.

SB2 is the first Samsung Bioepis biosimilar candidate submitted for review in the US. If approved, the marketing and distribution of SB2 in the US will be handled by Merck & Co., in accordance with a commercialization agreement signed in 2013. Remicade is marketed by Johnson & Johnson’s Janssen Biotech, Inc., based in Horsham, Pennsylvania. Remicade was one of Johnson & Johnson’s top-selling pharmaceuticals with global 2015 sales of $6.56 billion.

This BLA is the first application filed in the United States by Samsung Bioepis as part of its partnership with Merck to offer biosimilar alternatives to existing biologic medicines. The application seeks approval for use in all therapeutic indications currently approved for Remicade for which marketing exclusivity has expired. Merck and Samsung Bioepis announced in February 2013 a development and commercialization agreement under which Merck will commercialize multiple biosimilar candidates in certain partnered territories. Under terms of the agreement, Samsung Bioepis is responsible for preclinical and clinical development, process development and manufacturing, clinical trials and regulatory registration. Merck has full responsibility for commercialization of approved products resulting from the agreement.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) earlier this year issued a positive opinion for the marketing authorization of Flixabi (infliximab), an infliximab biosimilar candidate referencing Remicade. The biosimilar was developed by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen.

Earlier this year, the FDA approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is manufactured by Celltrion, Inc, based in Yeonsu-gu, Incheon, Republic of Korea, for Hospira (now part of Pfizer following Pfizer’s $17 billion acquisition of Hospira in 2015).

Samsung Bioepis continues to advance a broad pipeline of 13 biosimilar candidates, which includes the following six first-wave product candidates that cover the therapeutic areas of immunology, oncology and diabetes: SB4 biosimilar candidate referencing Enbrel (etanercept); SB2 biosimilar candidate referencing Remicade (infliximab); SB5 biosimilar candidate referencing Humira (adalimumab); SB9 (MK-1293) biosimilar candidate referencing Lantus (insulin glargine); SB3 biosimilar candidate referencing Herceptin (trastuzumab); and SB8 biosimilar candidate referencing Avastin (bevacizumab).

Sourece: Samsung Bioepis

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