EMA/CHMP recommends 6 new medicines and 3 generics for approval

22 November 2015
biosimilars_samples_large

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 10 medicines for marketing authorization at its November 2015 meeting.

Among these Benepali (etanercept), a biosimilar of Amgen's Enbrel from Samsung Bioepis, received a positive opinion for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis. The company is a joint venture between Samsung and US biotech firm Biogen Idec (Nasdaq: BIIB).

The CHMP recommended granting a marketing authorisation for Wakix (pitolisant) from Bioprojet Pharma for the treatment of narcolepsy. Narcolepsy is a rare, long-term sleep disorder which affects the brain’s ability to regulate the normal sleep-wake cycle, and may occur with or without cataplexy (sudden severe muscle weakness or loss of muscle control). Wakix, a first-in-class medicine, has an orphan designation. For more information, please see the press release in the grid below.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK



Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Biosimilars