Biosimilars organization hails US legislative effort
This legislation would make FDA-approved, lower-cost biosimilars more accessible for patients, according to Juliana M Reed, executive director of the Biosimilars Forum.
“Health equity and maximizing cost-savings for patients are at the forefront of the Biosimilars Forum’s mission. A shared savings reimbursement model can significantly close health equity gaps and deliver treatments to individuals and communities who need them most."
Biosimilars can save the health care system $133 billion by 2025 if they are fully available and accessible to the patients who need them, she added.
“This make-it-or-break-it year for the biosimilars industry requires the full support of policymakers and stakeholders to provide patients with the lower-cost treatments they deserve. I look forward to working with lawmakers on both sides of the aisle to get this moment right and deliver lower cost biosimilars for patients."
Progress
Last year was a remarkable one in many respects for the maturing US biosimilars field, with new launches and approvals and different legal issues explored, found life sciences attorneys Geoff Biegler and Jenny Shmuel, in a review.
The next 12 months are poised to bring even more developments in the biosimilars arena, with 10 or more Humira (adalimumab) biosimilar companies having settled with AbbVie and 2023 to see permitted launch dates for those products, noted those legal experts in January.
The biosimilar market could also expand with additional product approvals, said the attorneys. “For example, the FDA recently accepted biosimilar BLAs for Actemra (tocilizumab), a newer reference product first FDA-approved in 2010 for which there are currently no approved biosimilars. Other companies have renewed their commitment to biosimilars.”
Teva and Sandoz are both planning a significant ramp-up in production of biosimilars, with Teva reporting 13 and Sandoz reporting 15 biosimilars in development, they commented.
“This is all in addition to new expected guidance from the courts and regulatory agencies on how to navigate thorny issues related to regulatory approval and patent clearance.”
