Though flawed, the pathway for follow-on biologics establishes a new dialogue between the FDA and manufacturers, according to Steve Grossman of FDA Matters. It encourages different strategies for best-possible routes to market for follow-on, or biosimilar, products.
The new law “protects” the reference product from competitors, by denying competitors the benefits of the new approval pathway for 12 years. This isn't market exclusivity, because there are other ways to get a biosimilar approved. Also, this isn't data exclusivity, because the competitive product can have its own data and still not be able to use the new abbreviated pathway for approval. What, in fact, the new law has granted to the reference product is 12 years of “pathway exclusivity”...
For drugs approved more than 12 years ago, companies that wish to market biosimilars will choose between the abbreviated pathway and filing a full Biologic License Application ("BLA"). For drugs approved less than 12 years ago, companies will either wait, or go the full BLA route.
Many companies — even those with the opportunity to take the abbreviated pathway — will decide that the full BLA exceeds the cost of collecting additional data. Some will take the data from their biosimilars already approved in Europe, and discuss with the FDA which pathway is likely to work best.
Other companies will work towards approval of BLAs for so-called “bio-betters” — new products that are similar to an existing product, but which are safer, more effective or easier to use.
What comes next depends in part on the FDA. The new law clearly empowers the FDA to find ways to get more biosimilar products on the market. Since this can only be partially achieved through the abbreviated pathway, we believe the agency will be looking for ways to make the BLA process friendlier for biosimilar and bio-better products.
Any change in the ability of manufacturers to approach the FDA — or any change, for that matter, in the FDA's confidence in approving biosimilars — could unleash powerful market forces, and upset innovators, such as Amgen (AMGN), Genzyme (GENZ) and Genentech (DNA), longstanding balance and legal maneuvering.
Although overly restrictive patent law hamstrings the pathway itself, Grossman's argument suggests that investors can still expect manufacturers to pursue biosimilar products, even if via a traditional BLA process.
As the pathway stands now, for example, applicants must hand over the full application dossier to the reference product manufacturer 20 days after filing, in effect risking, upfront, privileged information on patents and corporate strategy.
Expect basic economics to dominate the drug supply chain over the coming months and years. Payers such as health plans and employers will demand a more competitive marketplace to drive down prices, and manufacturers will supply a larger number of competitive products.
A new dialogue with the FDA — or just regulatory confidence in biosimilars — provides a valuable opportunity for competitors to help payers improve affordability and access.
Disclosure: No positions