Biosimilar drugs saved $7.9 billion dollars in 2020 alone, more than tripling the $2.5 billion saved in 2019, according to the latest report from the Association for Accessible Medicines.
The goal of the pilot program is to allow American and European assessors the ability to concurrently exchange their views with applicants on scientific issues during the development phase of complex generic/hybrid products.
Rani has agreed to evaluate BFI-751 in its RaniPill capsule, a novel, proprietary and patented platform technology intended to replace subcutaneous or IV injection of biologics with oral dosing.
Brexpiprazole is an atypical antipsychotic indicated for use as adjunctive therapy to antidepressants for the treatment of major depressive disorder and schizophrenia.