Dosage Forms

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Articles

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.

It is important to use correct organization and appropriate methods for demonstrating biosimilar comparability to support regulatory filings.

Determining Comparability of Biosimilars Through Statistical Approaches

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.

Celltrion Reveals Positive Clinical Trial Data for Biosimilar Adalimumab

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

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

EC Approves Celltrion Healthcare’s Adalimumab Biosimilar

The company has launched its biosimilar rituximab, Ritucad, for the Indian market.

Cadila Pharmaceuticals Launches Biosimilar Rituximab 

The companies received approval from the EC for Zercepac (HLX02), a biosimilar referencing Roche’s originator biologic, Herceptin (trastuzumab).

Henlius and Accord Healthcare Receive European Approval for Biosimilar Trastuzumab

The committee has given a positive opinion on the biosimilar bevacizumab for several cancer indications.

CHMP Gives Positive Opinion on Centus Biotherapeutics’ Bevacizumab Biosimilar

The use of analytical assays is crucial for determining that biosimilar critical quality attributes remain on point.

Biosimilars and Biobetters