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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
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.
May 07, 2021
Sandoz will soon begin enrolling patients with neovascular age-related macular degeneration in a Phase III study with its proposed biosimilar to aflibercept.
February 17, 2021
The EC has granted marketing authorization to Celltrion Healthcare for its adalimumab biosimilar, Yuflyma (CT-P17).
August 13, 2020
The company has launched its biosimilar rituximab, Ritucad, for the Indian market.
The companies received approval from the EC for Zercepac (HLX02), a biosimilar referencing Roche’s originator biologic, Herceptin (trastuzumab).