Biogen Idec, Samsung Bioepis Target Anti-TNF Biosimilars in Europe
Biogen and Samsung Bioepis, a joint venture between Samsung Biologics and Biogen Idec, advance plans for anti-TNF biosimilar product candidates.
Biogen Idec and Samsung Bioepis, a joint venture between Samsung Biologics and Biogen Idec, has exercised its right to enter into an agreement to commercialize anti-TNF biosimilar product candidates in Europe, including biosimilars for widely used therapies to treat conditions such as rheumatoid arthritis and Crohn’s disease. Under the agreement, Biogen Idec will be responsible for commercialization of these product candidates across Europe, where there already exists a strong market for biosimilars and a defined regulatory pathway. The agreement with Samsung Bioepis aligns with Biogen Idec’s broader corporate objectives of remaining focused on its core business while applying expertise in manufacturing and specialty markets to meet the need for biosimilar therapies.
In February 2013, Samsung Bioepis and Merck & Co (known as MDS outside the United States) formed an agreement to develop and commercialize multiple prespecified and undisclosed biosimilar candidates. Under that agreement, Samsung Bioepis is responsible for preclinical and clinical development, process development and manufacturing, clinical trials and registration. Merck will be responsible for commercialization. Samsung Bioepis will receive an upfront payment from Merck, product supply income, and will be eligible for additional payments associated with prespecified clinical and regulatory milestones. Further financial terms were not disclosed.
Source: Biogen Idec
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.
