Biosimilars

Cipla acquires mAb manufacturer Mabpharm

Cipla acquires mAb manufacturer Mabpharm

By Zachary Brennan

Indian biopharma Cipla is pushing further into the realm of monoclonal antibody manufacturing with its purchase of India-based Mabpharm.

The cost savings of biosimilars is seen as a reason to allow similar INNs for biosimilars and biologics.

GPhA, retirees and pharmacies call for same INNs for biosimilars

By Zachary Brennan

The fight over how biosimilars should be named in the US just got more tense as a group of pharmacists, pension systems and the Generic Pharmaceutical Association are calling for a system similar to what’s used in the EU, with the same INNs (international...

EU green lights first insulin biosimilar from Lilly, BI

EU green lights first insulin biosimilar from Lilly, BI

By Zachary Brennan

The EU’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion and recommended granting a marketing authorisation to Boehringer Ingelheim and Eli Lilly’s biosimilar insulin treatment for Type 1 and Type 2 diabetes patients.

US FDA unveils long-awaited biosimilar guidance

US FDA unveils long-awaited biosimilar guidance

By Zachary Brennan

The FDA has finally released its biosimilar draft guidance for industry, which details how it will evaluate comparative analytical characterization of the biosimilar in relation to the reference product.

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...