FDA Greasing the Wheel for Biosimilar Adoption Through Action Plan

The US FDA has published an action plan to promote and expedite biosimilar competition. Healthcare consultant Steven Lucio tells us “we are at a critical point in time in the biosimilar development landscape.”

Last week, the US Food and Drug Administration (FDA) published a ‘Biosimilars Action Plan’ aimed at promoting access to lower-cost biosimilar drugs while maintaining a desire for new biologics innovation.

“By enabling a path for competition from biosimilars, we also give innovators an added incentive to invest in further research that’ll lead to the discovery of even better drugs that deliver additional benefits for patients,” FDA commissioner Scott Gottlieb said in a statement.

The plan involves 11 actions across four key areas: 1) Improving the efficiency of the biosimilar and interchangeable product development and approval process, 2) Maximizing scientific and regulatory clarity for the biosimilar product development community, 3) Developing effective communications to improve understanding of biosimilars among patients, clinicians, and payors, and 4) Supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay competition.

Expediting Biosimilar Adoption

According to Steven Lucio, associate vice president at member-driven, health care performance improvement company Vizient, the rate of adoption and – by extension – the degree of cost savings from biosimilars, has so far been very modest at best.

“Many factors have contributed to this slow rate of growth. For example, the statute granting FDA authority to approve biosimilars was enacted in 2010,” he told BioProcess Insider.

There are currently 12 biosimilars approved by the FDA, but only three have so far reached the market. This is due to patent protections and exclusivities for the branded biologics, which continue to be the subject of ongoing litigation, said Lucio, in addition to payor reimbursement practices which may affect a sponsors’ ability to successfully market biosimilars following approval.

“Many of these issues exist outside of the agency’s control. However, FDA is taking these 11 actions to ensure the mechanisms for approval work as efficiently as possible, therefore minimizing one hurdle that could impair the biosimilar market.”

Despite this, the FDA controls the most important issue: the timing of product approval. “Regardless of payor reimbursement strategies or clinician acceptance, a biosimilar cannot help lower the cost of pharmaceuticals if it is not licensed for marketing.”

According to the FDA’s action plan, as of July 1, 2018, 68 candidates were enrolled in the biosimilar development program.

“By addressing these uncertainties, FDA can expedite the approval of these remaining agents. The agency can also do a great deal in terms of educating physicians and other clinicians in accepting the safety and efficacy of biosimilars. Therefore, while FDA’s authority does not impact other barriers, it is still extremely influential.”

Looking Forward

Lucio is publishing a book later this month entitled ‘Biosimilars and Biologics: Implementation and Monitoring in a Healthcare Setting,’ giving an in-depth perspective across this space. We therefore asked him how the biosimilar landscape is likely to evolve over the next few years.

“We are at a critical point in time in the biosimilar development landscape. Our ultimate success –or failure – in creating an experience for biosimilars that approximates that of generics will be determined between now and 2023 as many ongoing patent challenges are expected to be resolved other this time period,” he said.

Over the next half-decade, versions of blockbuster biologics including Avastin, Herceptin, Rituxan, Neulasta, and Humira are likely to arrive in the US, he said.

“Establishing an environment in which the biosimilar paradigm is understood by clinicians and where the payor community considers these product as therapeutically comparable alternatives to the brand is completely within our reach.

“However, achieving that goal will require a sustained effort of education and advocacy as well as a commitment to look at longer term economic opportunity as compared to short-term value.”