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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

 Washington Editor, jillwechsler7@gmail.com.

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.



Celltrion Healthcare Gains Positive Opinion from CHMP for Biosimilar

The Center for Drug Evaluation and Research is studying factors that influence the development of generic versions of brand-name drugs.

Predicting Generic Drug Marketing Applications

Anurag S. Rathore is a professor in the Department of Chemical Engineering at the Indian Institute of Technology Delhi and a member of 

l's Editorial Advisory Board, Tel. +91.9650770650, asrathore@biotechcmz.com.

Narendra Chirmule, PhD, is CEO at SymphonyTech Biologics.

Himanshu Malani is a graduate student at the Indian Institute of Technology, Delhi.

Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.

Reimagining Affordable Biosimilars

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

Cadila Pharmaceuticals Launches Biosimilar Rituximab 

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

Biosimilars and Biobetters