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# 4 New Biosimilar Guidances
- URL: https://www.fdaweb.com/4-new-biosimilar-guidances/
- Published: 2018-12-11T12:00:00.000Z
- Updated: 2026-09-15T00:50:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143009

FDA commissioner **Scott Gottlieb** says the agency is taking steps to advance the framework outlined in the July Biosimilars Action Plan by issuing four new guidances, including one that takes on companies that are “using, and sometimes abusing, limited distribution systems, sometimes in connection with Risk Evaluation and Mitigation Strategy (REMS) programs, as a way to delay or derail access to reference product samples that sponsors need for testing to support their applications for a biosimilar product.” In a [statement](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628121.htm?ref=fdaweb.com), Gottlieb says that while limited distribution programs can have a patient safety role, too many branded products “are still misusing these programs as rhetorical smokescreens to hide anti-competitive behavior. We’re not going to be partners to these deceptions.”

One of the new guidances, Gottlieb says, tells how the agency will, upon request, review study protocols submitted by biosimilar applicants to assess whether they contain comparable safety protections to those in the REMS for the reference product. If requested, he says, FDA will issue a letter to the reference product company saying that comparable protections exist and that FDA will not consider it a violation of the branded company’s REMS to provide the biosimilar sponsor with a sufficient quantity of the reference product to perform testing necessary to support its application.

Two additional guidances, Gottlieb says, describe how FDA plans to implement Congress’ direction that certain biological products currently approved as drugs under the Federal Food, Drug, and Cosmetic Act be transitioned and licensed as biologics under the Public Health Service Act (PHSA). “Transitioning these drugs to the PHSA will let them be treated as biologics under that law,” he explains. “And that means opening them up to competition through the biosimilars pathway. This includes insulin, which has been historically regulated as a drug and not a biologic.”

The last of the four guidances deals with interpretation of the “deemed to be a license” provision of the Biologics Price Competition and Innovation Act of 2009, he says, and finalizes a 2016 draft guidance.

“We’re at a crucial stage in the development of a competitive market for biological products,” Gottlieb writes, “and FDA is committed to efforts that advance the science and policies to make the development of biosimilars and interchangeable products more efficient.”