The European Commission has launched the process for reshaping and addressing the long-standing weakness in the EU’s pharmaceutical legislation. It has listed in a roadmap the issues it wants to address as it considers policy options for reforms.

As Warwick Smith steps down after 25 years as leader of the British Generic Manufacturers Association, he talks about how far the country’s off-patent industry has come over the last quarter-century – including the acceptance of generics, the advent of biosimilars, and how freedom of pricing has helped to keep costs low while maintaining sustainable pricing – in the first part of an exclusive interview with Generics Bulletin.

Off-patent industry association Medicines for Europe has released a Biosimilar Market Review report that examines availability, pricing systems, retail markets, hospital tendering, reimbursement systems, healthcare practitioner-related policies, information and education around biosimilars in 26 European countries, concluding that “while progress has been made, it is clear much more can be done.”