Medicines for Europe has offered several suggestions to re-evaluate the EU’s pharmaceutical legislation, including moves to allow off-patent competition from day one of exclusivity expiry as well as to ensure a competitive and balanced single market for multi-source medicines. The European off-patent industry body also discussed access issues, unmet medical needs and incentives in its feedback.
Medicines for Europe has made a series of suggestions for improvements to EU pharmaceutical legislation in a response to the European Commission’s public consultation as it reviews its Pharmaceutical Strategy for Europe.
The off-patent industry body has recommended increased digitalization of the regulatory framework, policies that incentivize manufacturing investments, moves to allow off-patent competition from day one of exclusivity expiry and measures
As the US biosimilars market moves into its second decade, urgent changes are needed at the FDA if biosimilars are to meet their full potential, according to Biosimilars Forum chief executive Julie Reed.
With a lineup of five high-value biosimilars in the wings, Biocon Biologics may be more selective going forward and plans to take a one product per year approach.
The Belgian value-added medicines specialist company struck two commercialization deals over its novel valacyclovir oral suspension that span three continents, marking a further milestone in the product’s development.
