FDA Releases Biosimilar Action Plan

During a speech given today in Washington, DC, FDA Commissioner Scott Gottlieb, MD, announced the release of the long-awaited Biosimilar Action Plan.

The plan, posted simultaneously on the FDA website, is meant to spur biosimilar competition in the US marketplace by addressing 4 key areas:

• Improving the efficiency of the biosimilar and interchangeable product development and approval process
• Maximizing scientific and regulatory clarity for the biosimilar product development community
• Developing effective communications to improve understanding of biosimilars among patients, providers, and payers
• Supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay market competition to follow-on products

“While less than 2% of Americans use biologics, they represent 40% of total spending on prescription drugs,” said Gottlieb. “So, enabling a path to competition for biologics from biosimilars is a key to reducing costs and facilitating more innovation.”

Gottlieb explained that the current payment system and reimbursement models in the United States were designed in a single-source world, where there was typically only 1 biologic in a category and there was a lack of therapeutic variety or competition. However, that is not the case anymore, as many of the biologic categories are highly competitive with many products targeting the same disease.

“And so, we need to adopt a different approach to paying for these drugs. An ideal system would reimburse biologics in a competitively bid scheme, where we could take full advantage of the multi-source competition," he said.

Although potential savings from biosimilars have been estimated to be quite high (a RAND study estimated biosimilars could offer a savings of $54 billion from 2017 to 2026), “The real savings has been just a fraction of even the most conservative initial estimates," Gottlieb said. "You don’t have to look far to understand why. While the FDA has approved 11 biosimilars through 2018, only 3 are marketed in the US. Competition is, for the most part, anemic.”

Gottlieb cited litigation for delaying market access of biosimilar products as one of the reasons for the lack of competition, which can come with costs for patients and payers. To analyze the cost of such delays, the FDA recently conducted an analysis of biosimilar competition across all Organization for Economic Co-operation and Development (OECD) markets, the full results of which will be released soon, according to Gottlieb.

However, the initial findings of the study, which assumed that the savings achieved in the United States from biosimilars in terms of price discounts would be on par with what has been seen in other OECD nations, found that if Americans had the opportunity to purchase FDA-approved and marketed biosimilars, they could have saved more than $4.5 billion in 2017. Importantly, these estimated savings does not include savings from biosimilars approved in 2018.

In addition to litigation delaying market access for biosimilars, Gottlieb discussed how rebating schemes, patent thickets, and long-dated contracts have also deterred the entry of approved biosimilars. “We’re not going to play regulatory whack-a-mole with companies trying to unfairly delay or derail the entry of biosimilar competitors,” said Gottlieb.

In another effort to stave off competition from biosimilars, some payers have required step therapy or prior authorization on the reference biologic before patients are able to access a biosimilar. This is a practice that, according to Gottlieb, the FDA sees “no clinical rationale for,” due to the fact that in order for a biosimilar to be approved, the developer must demonstrate that the potential biosimilar has no clinically meaningful differences to the reference product.

Gottlieb also highlighted some key actions the FDA is taking to further spur competition and bring more biosimilars to the market, such as:

• Exploring whether data-sharing agreements with other regulatory systems could provide insight into biosimilars' real-world safety and efficacy, as well as facilitate the increased use of non-US licensed comparator products in similarity studies
• Updating the Purple Book and evaluating how to incorporate additional information to provide developers with more transparency
• Releasing finalized biosimilar labeling guidance
• Developing new FDA review tools, such as standardized review templates, that are tailored to biosimilar and interchangeable applications
• Taking new steps to challenge gaming tactics by partnering with the Federal Trade Commission (FTC) to address anticompetitive behavior

Gottlieb said that the FDA looks forward to participating with the FTC to identify ways to deter anticompetitive behavior and that those efforts “will be announced soon.”

In his final remarks, Gottlieb stressed that encouraging the competition of biosimilars in the US marketplace is not a task the FDA can accomplish alone. Achieving the cost savings projected by biosimilars will require actions from both the public and private sector to align reimbursement and formularies to encourage appropriate biosimilar adoption, drawing attention to and taking action against anticompetitive practices, and educating “providers and patients about biosimilars, and why people should have confidence in the safety and effectiveness of these FDA-approved products," he said.