FDA, FTC Need to Strengthen Biosimilar Efforts, AHIP Says

April 18, 2020

AHIP wants the FDA and FTC to streamline product approvals, clarify the regulations governing biosimilars, put a stop to attempts to discourage people from using biosimilars, and start educating providers and patients about the safety and efficacy of these products.

Although federal regulators have taken steps to push biosimilar development and circulation into higher gear, lots of things can be done to make this happen faster, a group representing health care payers said in an appeal to regulators.

“If these barriers to competition are not meaningfully addressed, the biosimilar marketplace could fail to deliver on its promise of lower costs and greater patient access to vital biologic treatments,” America’s Health Insurance Plans (AHIP) said in a letter to the FDA and the Federal Trade Commission (FTC).

The group said the FDA and FTC need to streamline product approvals, clarify the regulations governing biosimilars, put a stop to attempts to discourage people from using biosimilars, and start educating providers and patients about the safety and efficacy of these products.

The group also warned about anti-substitution laws being adopted by states. “These state-level requirements could limit patient access to drugs that are not clinically different yet cost less than their brand name counterparts,” AHIP said.

To read more of this story, visit CenterforBiosimilars.com.