According to the Pink Sheet, European Health Commissioner John Dalli has announced that the EU would be prepared to accept applications for biosimilar products with data from original biologic medicines that are not sourced from within the Union. The move, while expected, will breathe new life into a stagnant industry sector with few EU authorizations each year and is likely to send pharmaceutical manufacturers the surest signal yet that this is time to jump quickly onto the bandwagon.
Speaking at the European Generic medicines Association (EGA) annual meeting, Dalli acknowledged that while Europe had lit the touch paper of biosimilars development by coming up with the first regulatory framework, the explosion of biosimilars across the globe was gathering pace at an impressive rate. “I believe that this is a natural and positive trend, but I realize that the application of the EU rules on biosimilars do not fully match this trend,” he said. He added that the EU was ready to rectify this situation.
While Dalli’s announcement represents a significant boost for biosimilars manufacturers, the real icing on the cake is that EU acceptance of third-country comparability data could happen very quickly. This is because the commission now says that such a move only requires a re-interpreting the law, rather than a full-fledged legislative process, which could take up to five years. This would be accompanied by an update of the overarching guideline.The global development concept is also gathering pace in the U.S., where draft guidance suggests that “under certain circumstances” a sponsor might use data from studies comparing a proposed product with a non-U.S.-licensed product. FDA has confirmed in writing that an EU-referenced product could be used in comparative trials for application in the U.S. (Please note the use of the conditional “could.”)
The complete Pink Sheet story can be found here.