The United States Supreme Court issued its Amgen v Sandoz decision on June 12, 2017, ruling that under the Biologics Price Competition and Innovation Act (BPCIA), manufacturers are not required to await US Food and Drug Administration (FDA) approval before notifying brand-name biologic agent manufacturers their intention to market biosimilars. Sandoz sought to market a biosimilar version of Amgen’s filgrastim.
The ruling effectively reduced by 6 months the time needed to launch a new biosimilar.
“It’s big news,” said Caleb Alexander, MD, an associate professor of epidemiology and medicine, and founding co-director of the Center for Drug Safety and Effectiveness at the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland. “These products are an important means of addressing soaring drug costs.”
The US lags behind Europe and elsewhere when it comes to biosimilars development, Dr Alexander said. There are a number of reasons for that, he told Cancer Therapy Advisor, including stronger US intellectual property laws.
The Supreme Court ruling will have “major implications for the US market,” hastening the arrival of biosimilars in the clinic and market uptake, said Dave Picard, vice president of biosimilars & injectables at AmerisourceBergen, which is based in Philadelphia, Pennsylvania.
Biosimilars are associated with an estimated 15% to 20% savings compared to brand-name biologics, Mr Picard said. But as competition increases among biosimilars and prices decline, that savings could approach 50%, he added.
Yet according to Dr Alexander, biosimilars will not achieve the kind of cost-savings seen with generic versions of small-molecule drugs because of the inherent complexity of manufacturing biologics.
Health systems might also be slower to switch patients from branded to biosimilar versions of biologics than they are to switch from branded to generic small-molecule drugs, Dr Alexander said.
One reason for that is the still-unresolved BPCIA issue of “interchangeability.”
In January 2017, the FDA released draft guidance for industry on biosimilarity/biologic interchangeability criteria and the naming of biosimilars.1
The draft rules would allow the agency to determine a biosimilar “interchangeable” with its reference biologic “if the information submitted is sufficient to show that the biological product produces the same clinical result as the reference product in any given patient without compromising safety or diminishing efficacy,” explained American Society of Clinical Oncology (ASCO) chief medical officer Richard L. Schilsky, MD.