Topic

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

Articles

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).

Henlius and Accord Healthcare Receive European Approval for Biosimilar Trastuzumab

Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.

Analytical Assays Determine Biosimilar Product Quality

FDA/FTC collaborate to end false and misleading statements and discuss the future of biosimilars at March 2020 public workshop on a competitive marketplace for biosimilars.

Commentary: A Competitive Marketplace for Biosimilars

Industry opportunities are increasing for biosimilars, but companies should pay close attention to delivery device design to facilitate success.


The Design Driver for Biosimilar Adoption

Demonstrating interchangeability can ensure biosimilar substitutability at the pharmacy level.

Biosimilars Tackle Interchangeability Standards

Jill Wechsler is BioPharm International's Washington Editor, jillwechsler7@gmail.com.

FDA is encouraging alternative insulins and challenging anticompetitive practices.

Biosimilars Poised for Gains in US Market

As the date for transitioning the approval of biologic drug to a new pathway comes closer, FDA publishes a final rule and answers questions on the pathway changes. 

Biosimilars and Biobetters