Samsung Bioepis’ Marketing Authorization Application for SB3 trastuzumab biosimilar candidate accepted for review by the European Medicines Agency.
Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency (EMA) has accepted for review the company’s Marketing Authorization Application (MAA) for SB3, a biosimilar candidate referencing Herceptin® (trastuzumab). Herceptin® is a monoclonal antibody (mAb) indicated for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer. The MAA for SB3 was submitted in August 2016.
“Trastuzumab remains vital in treating breast cancer, the most prevalent form of cancer affecting women across Europe,” said Christopher Hansung Ko, President & CEO of Samsung Bioepis. “If approved, we hope our affordable, high-quality medicine will help realize the promise of biosimilars for breast cancer patients across Europe by widening patient access to this important, life-enhancing treatment option.”
SB3 is Samsung Bioepis’ fifth biosimilar candidate submitted to the EMA, following SB4 (etanercept), SB2 (infliximab), SB9 (insulin glargine) and SB5 (adalimumab). SB4 and SB2 have since received regulatory approval from the European Commission (EC). i SB3 is also the company’s first oncology biosimilar candidate submitted for regulatory review in Europe. If approved, the marketing and distribution of SB3 in Europe will be handled by Merck, which is known as MSD outside of the United States and Canada.
Samsung Bioepis Biosimilar Pipeline
Samsung Bioepis continues to advance a broad pipeline of 13 biosimilar candidates, which includes the following six first-wave candidates that cover the therapeutic areas of immunology, oncology and diabetes:
- SB4 biosimilar candidate referencing Enbrel® (etanercept)ii
- SB2 biosimilar candidate referencing Remicade® (infliximab)iii
- SB5 biosimilar candidate referencing Humira® (adalimumab)
- SB9 (MK-1293) biosimilar candidate referencing Lantus® (insulin glargine)
- SB3 biosimilar candidate referencing Herceptin® (trastuzumab)
- SB8 biosimilar candidate referencing Avastin® (bevacizumab)
Commercialization of Samsung Bioepis Biosimilars
Samsung Bioepis is responsible for the development and manufacture of all immunology and oncology biosimilar candidates in its pipeline, as well as global clinical trials and regulatory registration in all markets worldwide for these biosimilar candidates. Following approval, Samsung Bioepis biosimilar products are marketed and distributed by its commercialization partners, Biogen and Merck, which is known as MSD outside the United States and Canada.
Manufacturing of Samsung Bioepis Biosimilars
Samsung Bioepis and Biogen have a manufacturing partnership which brings together Samsung Bioepis’ technical leadership in manufacturing process development and Biogen’s rich heritage and expertise in manufacturing biologics. Samsung Bioepis’ biosimilars are manufactured in the same state-of-the-art drug substance facilities that have manufactured Biogen’s biologic medicines.
i SB4 and SB2 have received regulatory approval from the European Commission (EC) as Benepali® and Flixabi®, respectively.
ii In addition to EC approval, SB4 has received regulatory approval from Korea’s Ministry of Food and Drug Safety (MFDS) as BRENZYS™, Australia’s Therapeutic Goods Administration (TGA) as BRENZYS™ and from Health Canada as BRENZYS™.
iii In addition to EC approval, SB2 has received regulatory approval from the MFDS as RENFLEXIS™.
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Filed Under: Drug Discovery