The FDA released the Biosimilars Action Plan (BAP) on Wednesday, which details the key actions the agency is taking to encourage innovation and competition among biologics and the development of biosimilars.
According to the FDA, the BAP focuses on four 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, clinicians, and payors
- Supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay competition.
The agency says its modernizing its regulatory policies to make the development and approval process of biosimilars more efficient, and to accommodate new scientific tools capable of improving the comparison process between biosimilars and their reference products. The FDA hopes this last point will reduce the need for time-consuming clinical studies.
In a speech announcing the BAP’s release, Scott Gottlieb, FDA commissioner accused drug makers who manufacture biologics with high price tags of preventing competitors from entering the market by deploying “unacceptable” anti-competitive tactics, resulting in higher drug prices for patients
“Some of these tactics should be unacceptable to every member of the drug supply chain,” Gottlieb said in his speech, noting that just because the drug industry built its success by being business savvy and “smart competitors,” doesn’t mean every business tactic it deploys should be embraced.
While the BAP does not address such tactics specifically, since the FDA’s role is not to settle intellectual property disputes, it does address 11 steps the FDA will be taking to encourage the nascent biosimilars market with the overall goal of lowering prices for patients.
Gottlieb explained just how important it is to lower the cost of biologics by highlighting that although less than 2 percent of Americans use biologic drugs, they make up nearly 40 percent of all prescription drug spending. He also claimed that patients could have saved $4.5 billion in 2017 if all of the FDA-approved biosimilars were actually available in the United States.
Gottlieb indicated that under the BAP initiative, the FDA intends to strengthen its relationships with regulatory agencies in Europe, Japan, and Canada. The FDA is currently assessing the potential value data sharing agreements would provide when determining the real-world efficacy and safety of biosimilars.
The agency comments that the actions outlined in the BAP “will help create a more competitive market today, while creating greater incentives for sponsors to make the investments required to support future products that deliver greater benefits to patients and public health after statutory exclusivities have expired.”
(Source: The U.S. Food & Drug Administration; PR Newswire)
