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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 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.

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

Feliza Mirasol is the science editor for 

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 and Biobetters