Article Summary:
The FDA is launching an initiative to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs. The agency has published a draft guidance that would potentially make it faster and less costly for companies to develop and bring these biosimilars to market, leading to increased competition and lower drug costs for patients.
The key aspects of the FDA’s initiative include:
- Allowing developers to rely more on analytical testing rather than human studies to demonstrate that a biosimilar product is sufficiently similar to an existing FDA-approved biologic.
- Reducing the time frame to bring a biosimilar to market from 5-8 years to around 2-4 years, and saving companies around $100 million in development costs.
- Making it easier for biosimilars to be considered “interchangeable” with their brand-name counterparts, enabling pharmacists to substitute them without additional studies.
This move aims to increase competition in the biologics market, which has seen limited penetration of biosimilars so far due to the high costs and complexities involved. The FDA believes these changes will expand patient access to more affordable biosimilar options and generate significant healthcare cost savings.
While the FDA is taking these actions, the final guidance will still require congressional action to be binding. The agency is, however, actively promoting the increased use of interchangeable biosimilars as part of its broader mission to make healthcare more accessible and affordable.