Craig Burton is the senior vice president of policy and strategic alliances at the Association for Accessible Medicines. He is also the executive director of the Biosimilars Council. In his current role, Craig is responsible for leading policy development and issues management for AAM, directing the Biosimilars Council, and building relationships with strategic partners in the health care sector, including patient advocacy groups.

Craig served as deputy assistant secretary for legislation in the US Department of Health and Human Services. In this role, he advised the Secretary, senior Department leaders and White House officials on legislative strategy to achieve key priorities. Craig also served in the Senate, where he was health policy advisor to Senate Majority Leader Bill Frist, MD, and as professional staff on the US Senate Committee on Health, Education, Labor and Pensions.

Craig Burton

Escaping the Void: All Things Biosimilars With Craig & G

Co-hosts Craig Burton, executive director of the Biosimilars Council, and Giuseppe Randazzo, senior vice president of sciences and regulatory affairs at the Association for Accessible Medicines (AAM), tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."

This special vodcast series provided by The Center for Biosimilars

 was developed in partnership with the AAM and Biosimilars Council.

By Ashley Henyan, MA, MFA, director of communications at AAM

Since the passing of the Biologics Price Competition and Innovation Act in 2010, the FDA has approved over 70 biosimilar medicines. Since their entry to market in 2015, biosimilars have generated $36 billion in savings for America's patients and the US health care system. Biosimilars have proven they can unlock access to safe, effective, and more affordable treatments. But unfortunately, a dangerous trend threatens to halt progress related to biosimilar uptake and patient access. 

In February 2025, an analysis from the IQVIA Institute revealed a massive biosimilar void.

 A staggering 90% of biologic drugs losing patent exclusivity over the next 10 years have no biosimilar competition in the pipeline. This data underscores a flawed system that limits patient access and negatively impacts the livelihood of millions of Americans. 

However, when it comes to biosimilars, we have the tools to fix the problem. With the right focus, collaboration, and reforms, we can ensure biosimilars continue to bring value to patients, providers, and the broader health care system. 

With thanks to The Center for Biosimilars, this podcast series explores the current biosimilars landscape, dives into urgent actions needed from policymakers and regulators, and offers real-world insights into what changes are needed now to ensure the sustainability of the industry. 

1. Jeremias S. The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars. February 5, 2025. Accessed May 3, 2025. 

https://www.centerforbiosimilars.com/view/the-biosimilar-void-90-of-biologics-coming-off-patent-will-lack-biosimilars

Podcasts

To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."

Since the first biosimilar launched in 2015, these innovative medicines have generated significant savings for patients and the health care system, with future savings projected to grow exponentially in the coming years. 

However, a Medicare “negotiation” provision within the recently passed 

 threatens to undermine biosimilar competition by creating unprecedented price controls. This misguided provision could compromise future biosimilar development and inadvertently leave patients with costlier brand-name treatment options. As this bill becomes law, it is critical that lawmakers broaden patient access by pursuing solutions that promote fair biosimilar competition.

, Sarfaraz Niazi, PhD, outlined concerns with the characterization of price controls within the Medicare drug price negotiation provisions. Niazi claims “[the 

 provision] is price negotiation, and no one is forced to accept it”. Further, he states “it will help the adoption of biosimilars as they are in a better position to negotiate.” However, these claims must be scrutinized through the context of the real-world application of the provisions set forth within the language of the legislative text.

In this burgeoning market, biosimilars compete on comparable efficacy and lower prices. The Inflation Reduction Act would significantly reduce the competitive edge just as the market considers which potential competitors to bring to market. 

Under the bill, the Department of Health and Human Services would be required to negotiate prices for over 100 drugs—many of which would be reference biologics subject to biosimilar competition. Biosimilar manufacturers have no role in the negotiation process and would instead have to gamble on whether or not a reference biologic becomes 1 of the 100 negotiated drugs. If the reference biologic is selected for negotiations near the end of its exclusivity period, it’s product’s price will drop precipitously. This would then require the biosimilar competitors to price themselves even lower than the point of economic viability and out of the market entirely.

From product development to launch, the initial investment required to bring a biosimilar to market range from $100-$250 million. By creating substantial uncertainty in the market for the reference product, the Inflation Reduction Act makes it too risky for would-be biosimilar manufacturers to invest the decades of time and hundreds of millions of dollars required to produce lower cost alternatives. This would give costly brand-name medicines a de facto monopoly at a price likely higher than what patients would have paid in a traditionally functioning market with multiple biosimilar competitors.

While the bill does include a provision allowing the Secretary to temporarily pull any biologic drug from negotiations if biosimilar manufacturers prove unequivocally that biosimilar competition was feasible in the foreseeable future, brands would still be able to block biosimilar competition from getting off the ground. Biologic brands often file non-innovative patents that, in this case, would delay biosimilars past the point of the negotiation window – effectively rendering this safeguard provision useless.

Essentially, biosimilars are forced to accept the outcome of the negotiation process, and they would be in no position to establish any incentives for themselves.

 is that by artificially setting prices, it ignores the proven benefits of competition established by the Hatch-Waxman Act. Further, it bypasses bipartisan legislative solutions that would nurture future competition and sustainably lower prices.

, biosimilars have, in a relatively short time, proven themselves as a primary drivers of savings on prescription drugs. Biosimilars, on average, cost 50% less than the brand price at the time of the biosimilar launch and drive reference biologics to reduce prices by more than 28% on average. Biosimilar competition has already resulted in more than $12 billion in savings since 2015 and is projected to generate more than $130 billion by 2025 as uptake and adoption continues to grow. These figures overwhelmingly outweigh any potential savings from price controls.

Biosimilar competition has already delivered on its promise to generate savings and increase the availability of lower cost treatment options available to patients. Congress must work to bolster biosimilar competition by eliminating market and regulatory barriers to entry, cracking down on patent abuse and amending perverse incentive structures. These actions will create a more sustainable, more competitive, and more affordable pharmaceutical market than any price control ever will.

Criag Burton is the senior vice president of policy and strategic alliances at the Association for Accessible Medicines. He is also the executive director of the Biosimilars Council. In his current role, Craig is responsible for leading policy development and issues management for AAM, directing the Biosimilars Council, and building relationships with strategic partners in the health care sector, including patient advocacy groups.

Articles

In response to another opinion piece, Craig Burton, from the Association for Accessible Medicines, argued that the Inflation Reduction Act of 2022 could prevent biosimilar competition, and lower drug prices as a result.

Craig Burton

Escaping the Void: All Things Biosimilars With Craig & G

Opinion: The Inflation Reduction Act is a Step Backward for Biosimilar Competition