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June 05, 2024
Biosimilar analytical assessments focus on demonstrating biosimilarity and interchangeability with the reference biologic.
May 29, 2024
Bkemv (eculizumab-aeeb) is the first interchangeable biosimilar to Soliris (eculizumab) to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.
March 02, 2024
Despite a growing number of biosimilar approvals, market uptake remains a challenge.
September 28, 2023
The European Commission has granted approval for Tyruko (natalizumab), a biosimilar developed by Polpharma Biologics for treating multiple sclerosis.
September 18, 2023
The EMA’s Committee for Medicinal Products for Human Use has given a positive opinion on Sandoz’ biosimilar trastuzumab for breast and gastric cancer.
July 27, 2023
Teva Pharmaceuticals and Alvotech will expand their partnership for the development and commercialization of biosimilar candidates.
June 08, 2023
The collaboration between Samsung Biologics and Pfizer will focus on long-term biosimilars manufacturing.
June 01, 2023
Analytical characterization of biosimilars plays a crucial role in a successful path to regulatory approval.
May 31, 2023
Sandoz’s marketing authorization applications for a proposed biosimilar to denosumab are supported by a comprehensive analytical and clinical data package.
May 12, 2023
The new partnership between Sandoz, a Novartis division, and Just – Evotec Biologics will aim to develop and manufacture multiple biosimilars.