AHIP Says FDA, FTC Need to Strengthen Biosimilar Effort

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,” the AHIP said.

AHIP Wants to Shorten Product Exclusivity Period

The group said the 12-year exclusivity period for originator biologics is too long and isn’t necessary, as is often asserted, to incentivize drug companies to innovate and develop better products.

They also advised FDA to finalize guidance on the regulatory approval pathway for biosimilars and update interchangeability guidelines, which could increase investment in biosimilars.

The letter follows a March workshop between the FDA and FTC to discuss anticompetitive practices in the biological products industry.

Purple Book Should Be Searchable

AHIP commended FDA’s efforts to improve the usefulness of the Purple Book—a compendium of FDA-approved biological products—however, “future improvements should be aimed at making the Purple Book available in a searchable and interactive format and having it include more complete information,” the group said.

Drug manufacturers have gone too far with misleading information that casts biosimilars in the wrong light, the AHIP said. “Brand name biologic manufacturers have published materials that create uncertainty about biosimilars and discourage patients and health care providers from using them.” The group recommended that the FDA finalize draft guidance that can steer manufacturers toward a fairer representation of their products in advertising.

AHIP advised FDA and FTC to use their tools and authority to not only counter misinformation but also develop objective education materials for patients and providers.

More and Better Education About Biosimilars

A new FDA webpage dedicated to biosimilars provides educational materials in the form of fact sheets, explainers, and graphics.

Additionally, online videos, infographics, and agency partnerships with physician specialty societies and public health organizations ensure resources are widely distributed to the public.

“By providing fact- and science-based information about the safety and effectiveness of biosimilars, FDA can help promote physician and patient confidence that is necessary for encouraging market acceptance and widespread adoption of biosimilars,” the organization noted.

AHIP suggested FDA and FTC work on legislative efforts to address anticompetitive behaviors such as “pay-for-delay” settlements, which cause manufacturers to postpone biosimilar market entry, and citizen petitions that prolong drug monopolies.

No More Product Hopping

Other behaviors that need addressing include product hopping, which involves withdrawing a drug from market and replacing it with a new version with minor changes to prevent market entry for biosimilars, and product evergreening, the practice of making minor updates to existing products to extend patent protections, the AHIP said.

The group encouraged the FDA and FTC to engage with legislators to identify additional barriers to biosimilar competition and seek out solutions.

“We look forward to further collaborating with the agencies to advance policy solutions that can increase patient access to biosimilar products and deliver meaningful cost-savings for all Americans,” said the organization.