Posted by Michael Wonder on 16 Dec 2019
EMA closes out the year with 66 positive opinions for new medicines
17 December 2019 - This figure is grossly overstated.
The EMA claims that it issued 66 positive opinions for new medicines in 2019.
This tally includes opinions for:
- New medicines
- New vaccines
- New combination products
- New gene therapies
- New biosimilar medicines
- New hybrid medicines
- New generic medicines
A new generic medicine (or new biosimilar medicine) is NOT a new medicine. The tally for true new medicines for 2019 is much lower than 66. The EMA needs to be called out for this. Our estimate for 2019 is just 35. How does this compare with 2018? Further analysis in tomorrow's issue of MAESTrO Daily.
