Sponsor of an NDA-approved protein product subject to March 2020 ‘transition provisions’ should be able to seek biosimilar licensure of that same product without surrendering its ‘deemed’ 351(a) approval, company says, also requesting that FDA clarify parameters for ‘branded biosimilars.’

A new bill going through the German legislative process could oblige manufacturers of orphan drugs and certain other products to submit real-world data from registries that would impact pricing.

The BeNeLuxAI initiative was among the many topics covered at the DIA Europe 2019 conference in Austria last week. The cross-country coalition has some new drugs in its sights for joint pricing talks and the conference was given an insight into the workings of the collaboration by a Belgian health department advisor close to the initiative.

Price decisions based on straight calculation of medical costs avoided may overestimate value of a cure, Cassidy warns.

New payment models, registries and the Cross Border Healthcare Directive could help determine new ways to pay for potentially one-off treatments such as gene therapies in Europe.

Janssen’s Japan country president says while the company is committed to pursuing innovation, from a policy angle it would like to see this adequately rewarded, given the broader societal benefits it can bring. Amid increasing competition from the rest of Asia, the executive says Japan also has the chance to take a global research leadership position through appropriate reforms.

There was little on specific legislative proposals and a lot of time discussing broad questions that Congress has been asking for years about drug pricing.