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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 

 Washington Editor, jillwechsler7@gmail.com.

The Democratic legislative proposal to authorize price negotiations on costly medicines covered by Medicare has drawn opposition from brand pharmaceutical and biotech companies. 

Generic-Drug Makers Also Fight Price Controls

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.

Dr. Srishti Joshi is postdoctoral fellows at Centre of Excellence, Biopharmaceutical Technology, Indian Institute of Technology New Delhi.

Dr. Rozaleen Dash are postdoctoral fellows at Centre of Excellence, Biopharmaceutical Technology, Indian Institute of Technology New Delhi.

Neh Nupur is a research scholar at the Department of Chemical Engineering, Indian Institute of Technology New Delhi.

Shravan Sreenivasan is research scholars at the Department of Chemical Engineering, Indian Institute of Technology New Delhi.

The biopharmaceutical landscape of India is transforming in terms of regulatory policies, product development, and affordability.

Emergence of India as a Global Manufacturing Hub for Biosimilars

Editor of Pharmaceutical Technology Europe

The evolution of regulatory guidelines for biosimilars alongside improvements in knowledge and understanding provide a platform for growth in the European market.  

The Evolving Biosimilar Approach

Feliza Mirasol is the science editor for 

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

Bioanalytical Studies Support Biosimilars Approval Pathway

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.

Biosimilars and Biobetters