FDA Says it Can Approve Follow-On Biologics

KEYWORDS ClincalsTrials / FDA

The FDA released a white paper saying it has the ability to approve follow-on biologics without extensive clinical trials, although some trials would be necessary for the follow-ons to replace original products.

The paper came out as Congress is considering bills to create an approval pathway for follow-on biologics and while industry leaders are debating the importance of clinical testing for the products.

The FDA has a "scientifically based, case-by-case approach" to approve follow-on biologics and other similar products, according to the paper. The agency has been evaluating related protein products for more than 20 years, it added.

Not all products require preclinical and clinical testing, the FDA said, but the agency needs flexibility to select the appropriate tests to examine similarity to original products. In general, fewer tests will be necessary because the original products are already well known and characterized.

The agency's case-by-case approach allows it to set standards and select trials based on an evaluation of each product and its manufacturing alternations, the paper said. Additionally, the FDA expects to be able to approve more similar products over time. "As analytical technology continues to improve, the evaluation of structural similarity will become feasible for a wide range of products," the FDA said.

The white paper was published in the April 13 online issue of Nature Reviews Drug Discovery.