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Feliza Mirasol is the science editor for 

Articles

Establishing bioassay studies for biosimilar development is important for supporting regulatory filings.

Bioanalytical Studies Support Biosimilars Approval Pathway

 Washington Editor, jillwechsler7@gmail.com.

Biosimilar approvals and the advance of biosimilar testing and production may lead to greater access to alternative therapies.

Biosimilars Gain Traction with Regulators and Manufacturers

The agency approved Byooviz (ranibizumab-nuna), a biosimilar to Lucentis (ranibizumab injection), for the treatment of several eye diseases.

FDA Approves Biosimilar for Treatment of Eye Disease

Will FDA’s approval of Semglee create a surge in the development of interchangeable biosimilars?

Biosimilars Move to Center Stage

Thomas A. Little, PhD, is president, Thomas A. Little Consulting and BioAssay Sciences, 12401 North Wildflower Lane, Highland, Utah 84003, USA, drlittle@dr-tom.com.

Correct organization and appropriate methods for demonstrating biosimilar comparability are important for supporting regulatory filings.

Statistical Approaches for Determining Comparability of Biosimilars

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.

US Supreme Court Denies Sandoz Biosimilar Etanercept Petition

Sandoz will soon begin enrolling patients with neovascular age-related macular degeneration in a Phase III study with its proposed biosimilar to aflibercept.

Sandoz Begins Late-Stage Clinical Development for Biosimilar Aflibercept

Updates to user fee programs that fund FDA operations are being finalized by industry stakeholders for approval by Congress.

FDA and Industry Move to Renew New Drug User Fee Programs

The EC has granted marketing authorization to Celltrion Healthcare for its adalimumab biosimilar, Yuflyma (CT-P17).

EC Approves Celltrion Healthcare’s Adalimumab Biosimilar

Celltrion Healthcare has announced that EMA's CHMP has issued a positive opinion for the marketing authorization of CT-P17—an adalimumab biosimilar.



Biosimilars and Biobetters