Uptake Barriers Will Deter Future Competitors From Investing in Biosimilars, Julie Reed Warns

At the Festival of Biologics, Juliana (Julie) Reed, executive director of the Biosimilars Forum warned that if barriers to biosimilar uptake, including pharmacy benefit manager interference and patent thickets, are allowed to continue, companies will start to question the value of investing in biosimilar development.

The conference took place from March 20 to March 22, 2023 in San Diego, California.

Reed explained the financial risk that companies take on when choosing to develop a biosimilar. Companies spend nearly a decade developing a biosimilar and running preclinical and clinical trials, costing them hundreds of millions of dollars in research and developments funds.

Additionally, companies have to navigate the regulatory system, resulting in long waits for the FDA to conduct facility inspections and review the application. The patent system creates another challenge for companies as they may experience launch delays as a result of time-consuming lawsuits and settlements to postpone launch, like with adalimumab and etanercept biosimilars.

“If some of those biosimilars have absolutely no access, we will see the industry question: ‘Why spend this much money to develop something?”

Reed argued that development should be streamlined to allow for more biosimilars to enter the market and make biosimilar development more economical. Streamlining could include reducing the need for preclinical trials and removing switching study requirements for interchangeability.

She noted that the biosimilar market of today is more mature than when the biosimilars approval pathway was first implemented, meaning that new policies are needed to match what US regulators know about biosimilars now. She said that the FDA’s recent roadmap is a great first step but more needs to be done.

Reed also warned that if changes aren’t made to allow for more competition, competitors with launched biosimilars may decide to bow out and remove their product from the market.

“We need to do it soon because it’s a question of the long-term sustainability of this marketplace…. People need to recognize that this industry is maturing and the developers in this marketplace have been developing across many countries…. Most of [the Forum’s] members are multinational and when you added it up, they have hundreds of years of experience. There's no reason for us not to streamline.”

Reed said she believes that more market competition is the best way to lower prices. However, she mentioned concerns about whether too many companies are pursuing biosimilars in certain markets. In the United States, at least 10 companies are looking to bring biosimilars referencing Humira to market in 2023, 8 of which are FDA approved and 1 launched in January. Reed said the better question is whether competition will exist when all these products become available.

She pointed to the US pricing experience with insulin biosimilars. When Semglee, an insulin glargine biosimilar, originally launched, there was not great uptake. The company took back the product and relaunched it with 2 pricing structures. When Amgevita launched, it also had 2 list prices: one that was 5% below the reference product (Humira) and one that was 55% lower. One price reflects a high rebate; the other does not.

Reed explained that companies took on this strategy to encourage pharmacy benefit managers to add the biosimilars to formulary. “We expect this to possibly happen across every Humira [biosimilar] launching. We have a high rebate to get access—buy our way on. And then, we can also launch lower. Between the 2 discounts, the out-of-pocket cost is considerable for patients….This is something we have to do as manufacturers to get on formulary.