Citing “insufficient” labelling for biosimilars “given their unique scientific and regulatory status,” EuropaBio is calling on the EMA (European Medicines Agency) to amend their labelling requirements.
As Celltrion announced Monday that it filed the first monoclonal antibody for approval with the US FDA, investor groups are crying foul over some of the tactics used by others in industry to discourage the uptake of biosimilars in the US.
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...
European biopharmas trying to avoid “death valley” went to California this week according to industry groups, investors and officials who met in Belgium this week to discuss ways of making it easier for companies to access funding on this side of the...
As biopharma companies look to take advantage of a biosimilar market set to exceed $3.7bn by 2016, experts say the different regulations governing the follow-on biologics may be an issue as the markets become more developed.
Revising the regulations that govern gene and cell therapies - known as advanced therapy medicinal products (ATMPs) - will increase the number of marketing authorisation applications for such products and attract more Big Pharma involvement according...
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.
With in-house production and manufacturing capacity, as well as a deal with Merck Serono, India-based generics giant Dr. Reddy’s is looking to bring as many as four biosimilars to the EU market by 2019.
European drugmakers are seeking between six months and a year to prepare and print updated product information, including the black symbol for drugs that require additional monitoring as part of their approval.
The European Commission continues to be accused by European
industry of pushing 'green policies' that are stifling progress and
global competitiveness - the controversial REACH chemicals
legislation remains a sore point.
EU environment ministers met on Monday to further debate key issues
related to the chemical substances review, which has become one of
the fiercest political battlegrounds ever in the history of EU
A recent study designed to assess biopharmaceutical innovation in
the member states of the Organisation for Economic Cooperation and
Development has found that, in terms of innovation and
biotechnology industry development, Belgium...
The impact on the French chemicals industry of implementing the
European Union's REACH (Registration, Evaluation and Authorisation
of Chemicals) proposals could be as high €800 million in testing
alone and lead to the loss of...