Tag Archives: Samsung Bioepis

September, 2018

27 September
Samsung Bioepis’ BLA for SB5 Adalimumab Biosimilar Candidate Accepted for Review by the FDA

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) under the 351(k) pathway for SB5, a biosimilar candidate referencing HUMIRA® i (adalimumab). The BLA for SB5 was submitted by Samsung Bioepis in July 2018. …
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29 June
Biogen Expands Biosimilars Business by Exercising its Option to Increase Ownership in Samsung Bioepis

CAMBRIDGE, Mass., June 28, 2018 (GLOBE NEWSWIRE) — Biogen (Nasdaq:BIIB) announced today it has exercised its option to purchase additional shares of Samsung Bioepis Co., Ltd., a joint venture established in 2012 by Samsung BioLogics Co., Ltd and Biogen. Under the terms of the 2012 joint venture agreement, Biogen will pay Samsung …
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14 June
Samsung Bioepis and Biogen Announce Pooled Analysis Results of Anti-TNF Biosimilars BENEPALI, FLIXABI and IMRALDI

INCHEON, Korea & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. and Biogen (Nasdaq:BIIB) today announced pooled analysis results of three anti-tumor necrosis factor (anti-TNF) biosimilars – BENEPALI™ (SB4, etanercept biosimilar), FLIXABI™ (SB2, infliximab biosimilar), and IMRALDI™ (SB5, adalimumab biosimilar) – which will be presented at the Annual European Congress of Rheumatology (EULAR 2018) …
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21 December
FDA Accepts for Review Samsung Bioepis’ SB3 Trastuzumab Biosimilar Candidate

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced that the US Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) under the 351(k) pathway for SB3, a biosimilar candidate referencing Herceptin® i (trastuzumab). SB3 is Samsung Bioepis’ first oncology biosimilar candidate submitted for regulatory review …
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25 August
Samsung, Biogen Biosimilar Version of AbbVie’s Humira Approved in the European Union

ZUG, Switzerland–(BUSINESS WIRE)–The European Commission (EC) granted a marketing authorization for IMRALDI® (also known as SB5), an adalimumab biosimilar referencing Humira®.1 IMRALDI has been developed by Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen (NASDAQ, BIIB) and is approved for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis, …
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21 August
Samsung Bioepis and Takeda Collaborate for Development of Multiple Novel Biologic Therapies

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. announced today that it has entered into a strategic collaboration agreement with Takeda Pharmaceutical Company Limited (TSE: 4502) to jointly fund and co-develop multiple novel biologic therapies in unmet disease areas. The two companies will immediately begin working on the program’s first therapeutic candidate, …
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21 July
Merck’s Follow-On Biologic Basal Insulin Granted Tentative Approval from the FDA

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for LUSDUNA™ Nexvue™ (insulin glargine injection) 100 units/mL, a follow-on biologic1 basal insulin in a pre-filled dosing device. LUSDUNA Nexvue is being developed …
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26 April
Samsung Bioepis’ Biosimilar Version of Remicade Receives FDA Approval

INCHEON, Korea – April 24, 2017 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved RENFLEXIS™ (infliximab-abda), a biosimilar referencing Remicade®i (infliximab), across all eligible indications. In the US, RENFLEXIS™ is indicated for reducing signs and symptoms in patients with adult and …
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10 June
Samsung Bioepis Announces New Late-Stage Data on Three Biosimilars

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced new clinical data on its anti-TNF-α portfolio of Benepali® (etanercept), Flixabi® (infliximab) and SB5 (adalimumab) investigational biosimilar candidate. The data will be presented through seven poster presentations and an abstract publication at the Annual European Congress on Rheumatology (EULAR 2016), which is …
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4 April
Samsung Bioepis’ Infliximab Biosimilar Recommended for Approval in the European Union

INCHEON, Korea – April 1, 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 Flixabi® – a biosimilar version of Remicade® (infliximab), also known as SB2 – for the treatment of …
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