Senator aims to cut biosimilar 'red tape' with proposal to eliminate interchangeable status

In August, when the FDA approved Coherus’ Cimerli, a biosimilar version of Roche’s eye disease medicine Lucentis, the agency also took the unusual step of granting the copycat “interchangeable” status without requiring a switching study.  

While that move was unexpected at the time, it could become standard practice for biosimilars if one senator gets his way.

Last week, Sen. Mike Lee (R-Utah) introduced a proposal in Congress that would put an end switching studies and, in effect, make all approved biosimilars interchangeable. The goal of the Biosimilar Elimination Red Tape Act is to speed access to biosimilars, the senator said in a statement.

“Our regulatory environment is making it too difficult and expensive for biosimilars to make it to the market,” Lee said in a release. “It’s the patients who suffer from a lack of competition and high drug prices.”

The Pharmaceutical Research and Manufacturers of America (PhRMA) supports the way biosimilar approvals are conducted, according to a spokesperson. 

"Current law provides sufficient discretion, allowing the Secretary to waive particular requirements it deems unnecessary in determining the evidence necessary for interchangeability, including whether a switching study or studies will be useful in assessing the risk, in terms of safety and diminished efficacy, of switching between a reference product and a proposed interchangeable product," the spokesperson wrote in an email. "As such, PhRMA supports the current science-based approach that allows for sufficient FDA flexibility while ensuring patients’ access to safe and effective medicines."

Eliminating the interchangeable designation would also eliminate confusion about biosimilar approvals, the senator argues. The agency has granted the status to only four of the 39 biosimilars it has approved. It tacks on an additional—some say redundant—stamp of approval and allows pharmacists to switch to the copycat product without the consultation of a doctor.

Securing the designation requires a switching study that shows patients can alternate between the copycat and the reference product without any loss of safety, potency or purity. But some say this is a frivolous exercise.

Biosimilar expert Sarfaraz Niazi, an entrepreneur, author and former professor at the University of Chicago, points to the standards the FDA sets for approval of biosimilars as reason enough to eliminate interchangeability.

“Biosimilars have no clinically meaningful difference with their reference product, so if there is no difference, they should be interchangeable without extensive and expensive switching and alternating studies,” Niazi said in the release. “Creating two classes of biosimilars has weakened the trust in biosimilars.”

Eliminating the status is not a revolutionary idea. Regulators in Europe and the rest of the world don't distinguish some biosimilars as interchangeable. All are considered as such.

The U.S. Biologics Price Competition and Innovation Act of 2009 created the interchangeability status even though it also specified that all biosimilars were to have “no clinically meaningful difference” with their reference product.

Editor's Note: A statement from the Pharmaceutical Research and Manufacturers of America (PhRMA) was added after this story was initially published.