Despite the discussion that appeared to indicate a potential for flexibility at FDA, panel members did not give a definitive answer about which way they were leaning.
Dr, Kozlowski’s questions sometimes presented the case for stronger clinical trial requirements. Rasmus Rojkjaer testified on behalf of the Generic Pharmaceutical Association that data from non-U.S. referenced products should be allowed for applications to the FDA and trials should not be more extensive than those required for an innovator product.
Dr. Kozlowski said there had been cases in Europe where clinical trials were shown to be important because they uncovered information that changed the product’s development. He asked about Mr. Rojkjaer’s view of the idea.
Mr. Rojkjaer reiterated that biosimilar applications should not have over-arching rules governing their reviews.
"I think clinical trials has its role to play, but forcing the industry to fit into a one-[size]-fits-all kind of approach I think would seriously keep the development of these biogeneric compounds back," he said.
When Dr. James Roach, chief medical officer of Momenta Pharmaceuticals Inc., argued the trials should be positioned as supportive to existing data, Dr. Jenkins said the agency still has to decide how it will ensure biosimilars are actually similar enough to the reference product.
"We heard a lot of comments yesterday from patient groups and prescribers that they wanted to be very certain that the biosimilar would be highly similar to the clinical effect of the branded product," Dr. Jenkins said. "How do you reconcile those two viewpoints as far as where we should set the bar on determining the role of the clinical trials in establishing that there’s no clinically meaningful difference as the statute requires between the biosimilar and the reference product?"
Dr. Roach said he thought it was possible to provide a limited clinical data set in addition to the existing data package to gain a product approval. ☐
"The Pink Sheet" and this publication are both published by Elsevier.