FDA’s new guidances on Risk Evaluation and Mitigation Strategy (REMS) requirements aims to help generic and biosimilar drugs get to market faster.
FDA’s new guidances on Risk Evaluation and Mitigation Strategy (REMS) requirements aims to help generic and biosimilar drugs get to market faster.
“We believe that by making the process for developing a shared system REMS more efficient, we’ll discourage brand drug makers from using REMS as a way to block generic entry and help end some of the tactics that can delay access,” said FDA Commissioner Scott Gottlieb, MD, in a statement.
Related: Pharmacy chains praise Trump drug pricing plan
FDA’s safety programs should not be leveraged “as a way to forestall generic entry” after patent expiration on a brand drug, Gottlieb added. “Our market-based system for rewarding innovation is dependent on this kind of legal competition.”
The Association for Accessible Medicine, made up of generic and biosimilar drug manufacturers, praised the new guidances. “AAM applauds FDA for issuing these guidances to address one form of brand gamesmanship that has delayed generic and biosimilar competition and price reductions for patients,” said Chip Davis, president and CEO of AAM, in a statement. “Calls for voluntary action by brand companies to stop their efforts to thwart generic competition are not enough.”
Related: New deal staves off Humira biosimilar competition
Davis also urged Congress to pass the CREATES Act, “which will help put an end to these types of abuses and free up the generic and biosimilar competition the President is prioritizing in his ‘American Patients First’ platform.”
The first draft guidance, Development of a Shared System REMS, describes general principles and recommendations to assist sponsors with developing these programs. “The goal is to improve the clarity and efficiency for developing shared system REMS, which will enable timelier market entry for products that are part of these REMS,” Gottlieb said.
The second draft guidance, Waivers of the Single, Shared System REMS Requirement, describes when and how FDA will consider waiving the single, shared system requirement, and how generic applicants can request a waiver.
“Through the new policies that we’re advancing today, our aim is to help generic drug makers get their products through the development and approval processes efficiently while maintaining the safety controls sought by the REMS,” Gottlieb said.
Read next: Patient group pushes FDA to improve biosimilar education
FDA Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
March 27th 2025The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, as a result of a global settlement with Amgen, according to a company news release.
Read More
FDA Approves First Drug for Excess Hunger in Prader-Willi Syndrome
March 27th 2025Vykat XR will be available in April to treat the intense hunger that is a hallmark of the rare genetic disease Prader-Willi syndrome. The price is based on a patient’s weight, and the average patient in the clinical trials would have had an average annual cost of $466,200 for the first year.
Read More
FDA Approves Amvuttra for ATTR-CM in Extended Label
March 21st 2025This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
Read More