FDA may require bispecific antibodies to be compared with monospecific products
With about 100 bispecific antibodies either in clinical trials or soon entering, the FDA on Monday updated and finalized its guidance on developing bispecific antibodies, clarifying how it may require clinical trials to compare the bispecifics with an approved monospecific product.
In the era of immunotherapies, the case for bispecifics hinges on their ability to improve on monoclonal antibodies and more directly target cancer tumor cells, among other potential indications. Companies are already seeing some payoff, like Amgen’s bispecific Blincyto, which first won approval in 2018 and brought in about $380 million last year.
Premium subscription required
Unlock this article along with other benefits by subscribing to one of our paid plans.