Coherus BioSciences has had its say on the prospect of interchangeability for Humira biosimilars, shortly after Boehringer Ingelheim announced positive data from a ‘first-of-its-kind’ switching study.
Coherus BioSciences has confirmed it is not seeking to conduct any biosimilar interchangeability study for its proposed biosimilar Humira (adalimumab) product ahead of US market formation in 2023, stressing that it will not be required in order for the company to be competitive.
Boehringer Ingelheim and Pfizer are known to be chasing actively the controversial designations for interchangeability for their biosimilar adalimumab products,...
After a series of setbacks for its Lucentis (ranibizumab) biosimilar filing in the US, Xbrane Biopharma now has a fresh action date from the FDA – although any approval will be contingent on a successful agency reinspection of its manufacturing sites.
After previously partnering on denosumab, Alvotech and Dr Reddy’s have announced a further alliance to co-develop a biosimilar version of Keytruda (pembrolizumab).
Marking its first vertically integrated GLP-1 product in India, Biocon said the generic liraglutide was approved under CDSCO’s Rule 101, which recognizes approvals from “established and referenced serious regulatory authorities.”
