16/12/2016Samsung Bioepis’ Type II Variation Application for Indication Extension of Benepali® Receives Positive CHMP Opinion
· Samsung Bioepis receives positive CHMP opinion for its Type II variation application for the indication extension of Benepali® (etanercept) to include juvenile idiopathic arthritis and pediatric plaque psoriasis
· Approved by the European Commission in January 2016, Benepali® is the only etanercept biosimilar currently available in Europe.
INCHEON, Korea – December 16, 2016 – Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the Type II variation application for the indication extension of Benepali® – a biosimilar version of Enbrel®i (etanercept), previously known as SB4 – for the treatment of juvenile idiopathic arthritis and pediatric plaque psoriasis in patients weighing more than 62.5kg.
Benepali® received approval from the European Commission (EC) in January 2016, 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. Biogen is responsible for commercializing Benepali® 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.
Samsung Bioepis’ SB4 etanercept biosimilar has also been approved in Korea, Australia and Canada, where the biosimilar is being marketed by Merck, which is known as MSD outside of the United States and Canada, as BRENZYS™. SB4 also remains under review at Swissmedic and the Brazilian Health Regulatory Agency, or Agência Nacional de Vigilância Sanitária (ANVISA).
Samsung Bioepis Biosimilar Pipeline
Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates, which includes six first-wave candidates that cover the therapeutic areas of immunology, oncology and diabetes:
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 of the United States and Canada.
Manufacturing of Samsung Bioepis Biosimilars
Samsung Bioepis and Biogen have a manufacturing agreement for anti-TNF-α biosimilars, 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 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 Enbrel® is a registered trademark of Pfizer Inc.
ii SB4 has received regulatory approval from Korea’s Ministry of Food and Drug Safety (MFDS) as BRENZYS™, the European Commission (EC) as Benepali®, Australia’s Therapeutic Goods Administration (TGA) as BRENZYS™ and Canada’s Health Canada as BRENZYS™.
iii Remicade® is a registered trademark of Janssen Biotech, Inc.
iv SB2 has received regulatory approval from the EC as Flixabi®, the MFDS as RENFLEXIS® and the TGA as RENFLEXIS®.
v Humira® is a registered trademark of AbbVie Inc.
vi Lantus® is a registered trademark of Sanofi-Aventis.
vii SB9 (MK-1293) is being developed by Merck, which is known as MSD outside of the United States and Canada, with Samsung Bioepis partially investing in the biosimilar candidate’s development.
viii Herceptin® is a registered trademark of Genentech Inc.
ix Avastin® is a registered trademark of Genentech Inc.