Biosimilars

INN debate: IFPMA pushes for biosimilar label changes

Dispatches from DIA Euromeeting

INN debate: IFPMA pushes for biosimilar label changes

By Fiona BARRY

IFPMA will advocate for all biologics to have a qualifier added to their names at the WHO’s INN Consultation on April 8, the biologics giant Amgen has told BioPharma-Reporter.com.

Majority of EU member states say ‘no’ to INNs for biosimilars

Majority of EU member states say ‘no’ to INNs for biosimilars

By Zachary Brennan

Most EU member states “strongly supported” the idea that biosimilars should be closely aligned with their reference products, according to a summary of the European Commission’s pharmaceutical committee meeting released Monday.

What’s holding up biosimilars in the US? Researchers investigate

What’s holding up biosimilars in the US? Researchers investigate

By Zachary Brennan

Politics might not be the only obstacle in getting biosimilars approved in the US, though much of the rest of the world seems intent on obtaining approvals as fast as possible, according to a new report from research company Frost & Sullivan.

(Picture credit: Joe Flintham/flickr)

J&J and EGA differ on safety impact of same INNs for biosimilars

By Fiona Barry

Johnson & Johnson (J&J) has called on the US FDA to prevent biosimilars being given the same non-proprietary names as their original biologics, while the European Generics Association maintains the practice is “proven to be safe” and “supported...

Cobra Biologics moves to beef up mAb capacity

Cobra Biologics moves to beef up mAb capacity

By Gareth Macdonald

Corba Biologics has opted for a HyClone bioreactor to boost its antibody production capacity citing customer demand and biosimilars as the drivers for the investment.

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