医療従事者の為の最新医療ニュースや様々な情報・ツールを提供する医療総合サイト

Samsung Bioepis’ Marketing Authorization Application for SB3 Trastuzumab Biosimilar Candidate Accepted for Review by the European Medicines Agency

2016年10月04日 AM11:00
このエントリーをはてなブックマークに追加


 

INCHEON, Korea

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.

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20161003006644/en/

Samsung Bioepis headquarters in Incheon, Korea. (Photo: Business Wire)

Samsung Bioepis headquarters in Incheon, Korea. (Photo: Business Wire)

“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.

About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of 13 biosimilar candidates that include six first-wave candidates that cover the therapeutic areas of immunology, oncology and diabetes. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com.

# # #

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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20161003006644/en/

CONTACT

MEDIA CONTACT:
Samsung Bioepis Co., Ltd.
Mingi Hyun,
+82-32-455-6128
mingi.hyun@samsung.com

Related Posts Plugin for WordPress, Blogger...
 

同じカテゴリーの記事 

  • Murata Invests in MEMS Sensor Manufacturing in Finland
  • Evaluate Ltd: Small Drug Developers Continue to Hold All the Cards, While Young Device Makers Suffer from a Shrinking Pool of Buyers
  • ABLIC Inc. Launches the S-85M0A Series of Ultra-High Efficiency Step-Down Switching Regulators in the Industry’s Most Compact(*) Size
  • Vertex Receives a Positive PBAC Recommendation for Reimbursement of ORKAMBI® (lumacaftor/ivacaftor) to Treat Australians Ages Six and Over with Cystic Fibrosis and Two Copies of the F508del Mutation
  • 和铂医药与科伦博泰就PD-L1抗体A167开展全球战略合作