EU efforts to incentivize value added medicines – products that innovate around existing known molecules – are welcome, but do not go far enough. That was the message that came through at Medicines for Europe’s 30th annual conference in Dublin last month, where delegates heard that Europe could risk missing out on the benefits of reformulated medicines by focusing solely on incentivizing repurposing drugs with new indications.
Europe Must Not Squander Potential Of Reformulation
Pharmanovia And Medicines For Europe Executive Makes Case For Inclusion In Legislation
At a panel on value added medicines at Medicines for Europe’s 30th annual conference in Dublin, Pharmanovia CEO and value added medicines sector chair James Burt set out the case for expanding the scope of current EU pharma legislation proposals to reward reformulation alongside repurposing.

More from Europe
Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.
The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.
Health technology assessment body NICE said it has taken on feedback about the implications of allowing higher cost-effectiveness thresholds for some medicines after senior health economists offered diverging views on its methods.
The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
More from Generics Bulletin
Gedeon Richter has filed its Mochida-partnered tocilizumab biosimilar rival to RoActemra with the European Medicines Agency. But with several biosimilars already having won approval, the market could be competitive.
Accord received positive opinions for its Prolia and Xgeva biosimilars at the latest meeting of the EMA’s CHMP. Meanwhile, Celltrion picked up a nod for another Stelara biosimilar, while Rechon Life Science withdrew an application for human insulin.
Echoing wider sentiments in the biosimilar and generic drug industry, the IGBA has warned of the potential consequences of mercantilist tariffs on the global drug supply and their impact on industry and patients.