21 August 2018 - The FDA’s recently announced Biosimilars Action Plan will take steps to increase access for patients who need biologic medication to biosimilar drugs that are nearly identical to but potentially much less expensive than the original product.

In announcing the 11 point plan, FDA Commissioner Scott Gottlieb, MD, said the market for biosimilars still isn’t established and their ability to penetrate clinical practice still isn’t firm. “The policy and regulatory decisions that we make today are going to have a lot to do with whether we realise the promise for this new category of products,” he said.

The plan calls for developing and implementing new tools to improve the efficiency of the FDA’s biosimilar review process as well as drug manufacturers’ ability to correlate pharmacokinetic and pharmacodynamic responses with clinical performance. The FDA will also explore new data-sharing agreements with foreign regulators to use products that aren’t licensed in the United States as comparisons in certain studies serving as the basis for biosimilar approval.

Read JAMA article