FDA cuts testing requirements for biosimilars once again

The FDA has issued updated guidance that aims to make it easier for drugmakers to bring biosimilars of patent-expired biologic drugs to market, in the hope of reducing medicine prices.

In a pair of new documents, the US regulator sets out a plan to reduce the need for biosimilar developers to carry out clinical pharmacokinetic (PK) testing, in a move that it says could cut the cost of running these studies in half. In a statement, it suggested that this would reduce costs by around $20 million per biosimilar programme.

Last October, the FDA also proposed doing away with the need for biosimilar developers to run comparative efficacy studies (CES) to prove their drugs work as well as the reference product, in another initiative that aims to accelerate the rollout of cheaper biosimilar medicines. According to the agency, CES can take one to three years to complete and cost around $24 million.

The two measures are both designed to correct a disparity with other countries around the world and the US, where the rollout of biosimilars has been much slower, with 82 products on the market, which is roughly half as many as are on the market in Europe.

Biologic drugs made up only 5% of prescriptions in the US last year, but accounted for 51% of total drug spending, with many products costing hundreds of thousands of dollars per year. Moreover, only about 10% of biologic drugs expected to lose patent protection in the next decade currently have a biosimilar in clinical development.

The new recommendations "describe scenarios in which a biosimilar applicant may use clinical data from outside the US without additional data from a three-way PK study" involving the proposed biosimilar, the US reference product, and the product licensed outside the US.

It also does away with an earlier recommendation for at least one clinical PK study that directly compares the biosimilar with the US-licensed reference product, suggesting that a comparator product approved outside the US can be used instead "if scientifically justified."

FDA Commissioner Marty Makary said that "using common sense, we are embracing more precise analytical testing approaches than have been used in the past."

Makary set out his thinking on biosimilars in a recent editorial published in the Journal of the American Medical Association (JAMA), in which he said that the CES and PK reforms "address some of the primary barriers that have limited biosimilar competition: high development costs and complex market entry pathways."

Other aspects of US regulation of biosimilars are also being tweaked, including a plan to make it easier for developers to show interchangeability with the reference drug, meaning that the biosimilar can be substituted for the brand by a dispenser without the need for prescriber intervention.

Photo by Crystal Kwok on Unsplash.