Markets & Regulations

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.

Dendreon's European Provenge CMO to add capacity with plant acqusition

Provenge CMO PharmaCell contracted for 2nd product

By Gareth Macdonald

PharmaCell, the CMO that makes Provenge for Dendreon in Europe, has agreed to buy a facility from TiGenix to add capacity and a manufacturing contract for a second commercial product.

US biopharma regulatorst to get 2014 budget they wanted

update

US biopharma regulators to get 2014 budget they wanted

By Gareth Macdonald

The US regulatory scientists who oversee biopharmaceuticals appear to be getting the funding they asked for after politicians pass a $1.2tr (€882bn) Government spending plan for fiscal 2014.

(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...