Celltrion/Hospira take lead in biosimilar MAbs as EMA OKs Remicade competitor
This article was originally published in Scrip
The European Medicines Agency has recommended approval of the first biosimilar monoclonal antibody products in the EU: Celltrion/Hospira's Remsima and Inflectra, which are versions of Johnson & Johnson/Merck & Co's Remicade (infliximab).
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.