FTC move could slow progress on US biosimilars pathway
This article was originally published in Scrip
The Federal Trade Commission's decision to look into the competition aspects of any future approval pathway for biosimilar medicines in the US is a welcome move to head off possible anti-competitive behaviour in this sector.
You may also be interested in...
A lower first dose boosted the vaccine’s efficacy result, but AstraZeneca has conceded that this has to be proven in a separate trial. In the meantime, the UK government has asked the regulator to assess the vaccine under a special health emergency provision.
Australian patients with phototoxicity due to the rare condition EPP will now have their first treatment option – provided the drug's developer, Clinuvel, secures reimbursement under the Pharmaceutical Benefits Scheme.
European Commission proposals for strengthening intellectual property protections in the EU, particularly the supplementary protection certificate (SPC) system, have been broadly welcomed by the European pharmaceutical industry federation EFPIA. But the medical NGO, MSF, says the SPC proposals run counter to the commission’s own efforts to improve access to medicines.