Drugmakers blocking biosimilar expansion should expect scrutiny: FDA and FTC

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Trine K. Tsouderos HRI Regulatory Center Leader, PwC US February 14, 2020


The FDA and the Federal Trade Commission (FTC) have embarked on a joint effort to crack down on “anti-competitive business practices” that they say may be obstructing the biosimilars market.

The two agencies are targeting advertising and other communications that misrepresent biosimilar products’ safety and efficacy, efforts to block biosimilar applicants’ access to reference product samples they need for FDA-required testing, and patent settlement agreements under which reference biologic makers pay biosimilar manufacturers to delay product introduction.

To address one issue, the FDA issued nonbinding draft guidance offering do’s and don’ts for promotional labeling and advertising by biologic and biosimilar product makers. For example, because licensed biosimilars are found by the FDA to have no clinically meaningful differences compared with their reference products, the agency would view communications suggesting that a reference product is safer or more effective to be false or misleading. Comments on the draft are due to the FDA by April 6.

Biosimilars have gotten a relatively slow start in the US. Only 14 of the 26 approved by the FDA so far are even for sale, according to data provided to HRI by the AAM, a trade group representing biosimilar and generic medication manufacturers.

Leveling the playing field for biosimilars would lower costs and increase treatment options for patients, the agencies said in their joint statement. In the US, initial list prices for biosimilars are 15% to 35% lower than those of corresponding reference products, they said.

“Strengthening efforts to curtail and discourage anti-competitive behavior is key for facilitating robust competition for patients in the biologics marketplace, including through biosimilars, bringing down the costs of these crucial products for patients,” FDA Commissioner Stephen M. Hahn said in a statement.

The FDA and FTC vowed to collaborate on public outreach efforts to promote greater competition in the biologics market and have scheduled a joint workshop on March 9. The FDA also said it will develop materials to educate consumers and providers about biosimilars.

HRI impact analysis

Biologics are complex compounds that are more expensive to discover, develop and manufacture than small-molecule drugs. In a June 2019 report, HRI identified prescription drugs, particularly biologics, as a 2020 medical cost inflator.

Although less than 2% of prescriptions are biologics, the US spent $125.5 billion on them in 2018—36% of total drug spending, according to a 2019 AAM report. Use of biosimilars could save up to $54 billion over 10 years, the association said.

But uptake of biosimilars has been slow because of a variety of factors, according to a 2018 HRI survey of clinicians. It found that while physician and patient concerns about safety and efficacy play a role, the chief reason doctors aren’t prescribing biosimilars is lack of familiarity with them.

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Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Crystal Yednak

Senior Manager, Health Research Institute, PwC US

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