Ten years on, EMA completes overhaul of biosimilar guidelines
This article was originally published in Scrip
With the publication of a revised version of its guideline on non-clinical and clinical issues, the EMA has completed the updating of its trio of overarching guidelines on biosimilar products, nearly ten years after they were first published in 2005 and 2006.
You may also be interested in...
Health ministers have called for more action on access to medicines, including a new EU work agenda, rebuilding Europe’s manufacturing capabilities, further action on pricing, and greater leeway for member states to mitigate drug shortages by restricting parallel exports.
Products from Novartis, Celgene and Merck could get an EU approval recommendation at this week's CHMP meeting.
The EU’s new health commissioner, Stella Kyriakides, has outlined the commission’s plans for dealing with medicines access issues in the EU member states. They include completing the review of the EU pediatric and orphan legislation and developing a new strategic plan to tackle shortages and affordability problems next year.