EMA prepares to publish draft guideline on biosimilar MAbs
This article was originally published in Scrip
The long-awaited draft guideline on developing biosimilar monoclonal antibodies is due to be published this week after it was adopted by the European Medicines Agency's scientific committee, the CHMP, at its 15-18 November meeting.
You may also be interested in...
New guidance from the UK regulator covers distribution and deployment of Pfizer/BioNTech's COVID-19 vaccine, which will be complex because of the temperature storage requirements and the large packs in which the vaccine doses will be delivered.
The UK’s rapid authorization of the Pfizer/BioNTech COVID-19 vaccine has sparked a public debate over regulatory processes at some of the world’s key regulatory bodies.
The Pink Sheet explains the procedures underpinning the UK’s emergency use authorization of the Pfizer/BioNTech COVID-19 vaccine.