Dosage Forms

Articles

The European Commission (EC) has approved Celltrion Healthcare's Vegzelma (CT-P16), a biosimilar to bevacizumab referencing Avastin.

European Commission Approves Bevacizumab Biosimilar from Celltrion Healthcare

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Biosimilar data analysis must demonstrate a correlation between structure and function.

Developing Methods for Analyzing Biosimilars

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.

Biocon Biologics to Acquire Biosimilars Assets from Viatris in $3.3 Billion Deal

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.

Samsung Biologics to Acquire Full Ownership of Samsung Bioepis in $2.3 Billion Deal 

Jill Wechsler is Pharmaceutical Technology's 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.

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.

Biosimilars and Biobetters