The Patent Doc blog offers these comments from the recent FDA hearings toward the implementation of the Biologics Price Competition and Innovation Act (BPCIA). Major discussions emerged around the following topics:
- Data exclusivity and "evergreening"
- Product naming issues and pharmacovigilance
- Post-market changes or drift in product
The debate on exclusivity came down to how strictly to interpret the 12-year exclusivity period. The innovators would like strict interpretation so that data exclusivity would be granted to products with any structural differences that lead to any change in potency, purity or safety. Patient groups want more lenient interpretation to allow for minor alterations so a barrier to market entry won't be unduly erected to biosimilars.
Innovators want to see the EMA's preferred International Nonproprietary Name (INN) convention adopted that requires biosimilars to be assigned to a unique name that is globally recognized as different from the reference product, ie. make it harder to substitute. Biosimilar proponents want to see the FDA's National Drug Code and lot numbering system adopted. This can be better used to track adverse events - and presumably show there are fewer than expected with biosimilars. Plus INN numbers make it harder to gain insurer coverage, another reason innovators would be against this covention and for INN.
Post-market changes or product drift become important when looking at the question of interchangeability. Innovators suggest that drift could best be controlled by high interchangeability standards. Biosimilar proponents want [EVERYBODY NOW] lower interchangeability standards. They suggest the FDA use studies similar to what they use to approve process changes for currently marketed reference drugs.
The upshot is there is more work to do. FDA Commissioner, Margaret Hamburg said, "It's a complex challenge. I can't put dates on our timelines for implementation." It may take many months for the FDA to finalize its approval pathway.
Posted by Bruce Lehr November 23rd 2010.