ACR asks for FDA guidelines on biosimilar substitution

During a public meeting on the reauthorization of the Biosimilar User Free Act, Angus Worthing, MD, FACR, FACP, incoming chair of the American College of Rheumatology’s Governance Affairs Committee, asked the FDA to create guidelines for biosimilar substitution.

“Substituting non-interchangeable biosimilars, especially without notifying the prescribing provider, poses uncertain safety risks to rheumatology patients due to the complexity of these drugs and the possibility of patients being forced to switch,” Worthing said. “Therefore, we recommend that the FDA promote clear guidelines for biosimilar substitution and adopt a post-marketing surveillance program to monitor for adverse events related to non-interchangeable substitution.”

The meeting was organized to garner stakeholder feedback on the reauthorization of the Biosimilar User Free Act (BsUFA), which allows the FDA to collect fees from pharmaceutical companies to speed up the biosimilar review process. To give physicians more confidence in biosimilars, Worthing — the only physician on the panel — asked the FDA to include interchangeable status and clinical data on biosimilar product labelling.

“Given the substitution safety concerns noted by rheumatologists, we strongly recommend that biosimilar labels clearly indicate whether the biosimilar is ‘interchangeable’ or ‘not interchangeable,’” he said. “Doctors expect to learn about a drug’s clinical data from FDA labels. To increase prescriber confidence and enhance market uptake, we recommend including clinical data on the label or via a hyperlink.”

In addition, he urged Congress to increase funding to the FDA.

“While the BsUFA represents an important source of funding, it is simply not enough for an undertaking of this magnitude,” Worthing said. “The ACR calls on our congressional leaders to appropriate funding to increase FDA’s capacity to hire staff, issue rules and guidance, and enact the appropriate post-market surveillance to protect the health and safety of Americans who rely on these therapies.”

Reference:

www.rheumatology.org/

During a public meeting on the reauthorization of the Biosimilar User Free Act, Angus Worthing, MD, FACR, FACP, incoming chair of the American College of Rheumatology’s Governance Affairs Committee, asked the FDA to create guidelines for biosimilar substitution.

“Substituting non-interchangeable biosimilars, especially without notifying the prescribing provider, poses uncertain safety risks to rheumatology patients due to the complexity of these drugs and the possibility of patients being forced to switch,” Worthing said. “Therefore, we recommend that the FDA promote clear guidelines for biosimilar substitution and adopt a post-marketing surveillance program to monitor for adverse events related to non-interchangeable substitution.”

The meeting was organized to garner stakeholder feedback on the reauthorization of the Biosimilar User Free Act (BsUFA), which allows the FDA to collect fees from pharmaceutical companies to speed up the biosimilar review process. To give physicians more confidence in biosimilars, Worthing — the only physician on the panel — asked the FDA to include interchangeable status and clinical data on biosimilar product labelling.

“Given the substitution safety concerns noted by rheumatologists, we strongly recommend that biosimilar labels clearly indicate whether the biosimilar is ‘interchangeable’ or ‘not interchangeable,’” he said. “Doctors expect to learn about a drug’s clinical data from FDA labels. To increase prescriber confidence and enhance market uptake, we recommend including clinical data on the label or via a hyperlink.”

In addition, he urged Congress to increase funding to the FDA.

“While the BsUFA represents an important source of funding, it is simply not enough for an undertaking of this magnitude,” Worthing said. “The ACR calls on our congressional leaders to appropriate funding to increase FDA’s capacity to hire staff, issue rules and guidance, and enact the appropriate post-market surveillance to protect the health and safety of Americans who rely on these therapies.”

Reference:

www.rheumatology.org/