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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
October 01, 2021
Establishing bioassay studies for biosimilar development is important for supporting regulatory filings.
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 01, 2021
Will FDA’s approval of Semglee create a surge in the development of interchangeable biosimilars?
August 01, 2021
Correct organization and appropriate methods for demonstrating biosimilar comparability are important for supporting regulatory filings.
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.
May 01, 2021
Updates to user fee programs that fund FDA operations are being finalized by industry stakeholders for approval by Congress.
February 17, 2021
The EC has granted marketing authorization to Celltrion Healthcare for its adalimumab biosimilar, Yuflyma (CT-P17).
December 11, 2020
Celltrion Healthcare has announced that EMA's CHMP has issued a positive opinion for the marketing authorization of CT-P17—an adalimumab biosimilar.