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August 23, 2022
The European Commission (EC) has approved Celltrion Healthcare's Vegzelma (CT-P16), a biosimilar to bevacizumab referencing Avastin.
July 06, 2022
Biosimilar data analysis must demonstrate a correlation between structure and function.
March 02, 2022
Biocon Biologics will acquire Viatris’ global biosimilars business, including the company’s portfolio of in-licensed biosimilar assets, in a transaction valued at over $3.3 billion.
January 28, 2022
Samsung Biologics has signed an agreement with Biogen to acquire Biogen’s 50% stake in Samsung Bioepis, a joint venture formed by the two companies, for up to $2.3 billion.
September 27, 2021
Biosimilar approvals and the advance of biosimilar testing and production may lead to greater access to alternative therapies.
September 21, 2021
The agency approved Byooviz (ranibizumab-nuna), a biosimilar to Lucentis (ranibizumab injection), for the treatment of several eye diseases.
September 02, 2021
Will FDA’s approval of Semglee create a surge in the development of interchangeable biosimilars?
August 31, 2021
It is important to use correct organization and appropriate methods for demonstrating biosimilar comparability to support regulatory filings.
June 03, 2021
Celltrion Healthcare has revealed positive one-year results from a Phase III trial comparing biosimilar adalimumab, Yuflyma, with the reference adalimumab in patients with rheumatoid arthritis.
May 18, 2021
The US Supreme Court has denied a petition by Sandoz, a Novartis company, to review a July 2020 ruling concerning its biosimilar Erelzi (etanercept-szzs), blocking the company from launching the product.