OTBB head Sarah Yim says FDA internal thinking is not aligned on the idea and that a lot of convincing was necessary to drop the clinical study requirement for insulin biosimilars.
An all-encompassing policy that biosimilars will not need comparative efficacy studies for approval seems unlikely for the US Food and Drug Administration, even as some officials continue to push in that direction.
Sarah Yim, director of the FDA’s Office of Therapeutic Biologics and Biosimilars, said the agency is taking a case-by-case approach,...
The US Supreme Court is seeking the administration's view following the Federal Circuit decided to reopen Amarin’s case against the ‘skinny-label’ generic Vascepa (icosapent ethyl).
Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.
Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.
