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Congressional Doctors Press FDA for Biosimilar Labeling Rules

Washington, December 21, 2015 | Greg Brooks (202-225-3164)

 A dozen members of the House Doctors’ Caucus sent a letter to the Food and Drug Administration highlighting physician and patient concerns regarding labeling requirements for new biosimilar products.  Five years after the passage of the Biologics Price Competition and Innovation Act (BPCIA) and nine months after the FDA’s approval of the first biosimilar, patients and physicians still await necessary clarity and guidance on the labeling of biosimilar drugs.

“At a time when many Americans are concerned about the rising cost of prescription drugs, biosimilars show a lot of promise in both increasing access to treatment and reducing health care costs,” Congressman Brad Wenstrup (R-OH) said. “This will only be the case, however, if physicians feel comfortable prescribing them and patients feel safe taking them.”

The letter calls on the FDA to pursue an inclusive and transparent process for the development of BPCIA policies. Wenstrup, a physician of over 25 years, led the letter after hearing repeated concerns about health care providers not being heard in the FDA rulemaking process. The FDA should “get the clear input of patients and physicians alike. Too often, we see final guidance issued without taking into consideration the practical needs of the physicians who prescribe these products on a daily basis or the patients who are trying to actively manage their treatment, explained Wenstrup.

The letter notes that the FDA’s 2012 draft guidance included a number of labeling requirements for biosimilar products, in effort to clearly distinguish them from their biologic reference products; however, the final guidance issued earlier this year dropped these requirements without explanation. This lack of guidance is having a real world impact, exemplified by the approval of the first biosimilar drug. The letter highlights that the label of the first approved biosimilar is “virtually the same” as the innovator product, meaning that it does indicate that it is a biosimilar product, nor that it has not been designated as interchangeable with the reference biologic.

“It can often be challenging and time consuming to find an effective treatment for many of the diseases that are treated by biologics. Unlike generics, biosimilars are not identical to the biologic drug. Therefore, it is essential for providers to be able trust the product descriptions in order to confidently prescribe them for their patients,” said Wenstrup.


Wenstrup Biosimilars Letter to FDA

Office of Representative Brad Wenstrup