Makers of insulin, growth hormones could see biosimilar competition

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Erin McCallister Senior Manager, Health Research Institute, PwC US February 28, 2020

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Dozens of medicines, such as insulins, that have long been protected from “generic” competition may now be subjected to it thanks to a new final definition of a biologic protein issued by the FDA. Published this month, the agency’s definition states that a protein is any amino acid polymer with a specific, defined sequence of 40 amino acids or more.

The new definition means that proteins previously approved under the Federal Food, Drug and Cosmetic Act as New Drug Applications (NDAs) will be considered “biologics” and subject to potential competition via the biosimilars pathway. Generic formulations for drugs approved via the NDA process must demonstrate “sameness,” which is challenging for complex proteins such as insulin, growth hormones and others. As a result, generic versions of these medicines have been rare.

In a statement announcing the new definition, FDA Commissioner Stephen Hahn said: “This transition will open new pathways for manufacturers to bring biosimilar and interchangeable versions of insulin and other transitioning products to market, facilitating greater competition in the marketplace.”

The list of transition products includes 27 different insulin-containing products as well as several growth hormone products and a few enzyme-replacement therapies that are approved to treat rare diseases. The oldest initial approvals among the products date back to the 1960s and 1970s, while several others were approved between 1980 and 1999.

The transition of the products becomes effective March 23, when the drugs will be added to the FDA’s online searchable Purple Book, launched Feb. 24. The Purple Book is intended to be a repository of all biologics approved by the FDA along with information about biosimilars, their reference product and whether they’re approved to be interchangeable.

HRI impact analysis

The cost of insulin has grabbed headlines over the past year and has spurred at least two dozen states to introduce bills that would limit out-of-pocket spending on insulin. Additionally, the FDA has sought to increase competition in the insulin market.

The agency issued draft guidance in December in which it proposed a modestly easier path to market, stating that biosimilar insulin manufacturers would not be required to conduct additional immunogenicity studies to receive FDA approval if they used certain technologies to demonstrate that the product was “highly similar” to the reference product.

The biosimilars pathway was created to reduce the cost burden associated with biologics once the exclusivity period for the innovator biologic ends. A June 2019 report by HRI identified prescription drugs, particularly biologics, as a 2020 medical cost inflator.

A 2019 AAM report estimated that biosimilars in the US could save up to $54 billion over 10 years.

However, biosimilars have struggled to make it to the market, and for the few that have been launched, uptake in the US has been slow. A 2018 HRI survey of clinicians found that the chief reason biosimilars aren’t being prescribed is a lack of familiarity with them.

Additionally, earlier this month, the FDA and the Federal Trade Commission announced a joint effort to crack down on anti-competitive business practices by drugmakers that could be obstructing uptake of biosimilars.

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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

Erin McCallister

Senior Manager, Health Research Institute, PwC US

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