We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The EMA’s Committee for Medicinal Products for Human Use recommended approvals for six drugs within the EU to treat a range of conditions from an endocrine disease to nausea. Read More
The U.S. solicitor general and several generics makers have filed U.S. Supreme Court briefs in support of reversing a Federal Circuit ruling that orders sponsors to wait six months after an FDA approval to launch a biosimilar. Read More
China’s Ministry of Human Resources and Social Security has expanded the list of drugs covered by state insurance, adding more than 300 drugs to the catalog since it was last updated in 2009. Read More
The Supreme Court ruled to limit the reach of patent protections on single components of a multicomponent product exported for manufacture abroad, reversing an appellate court decision in a unanimous ruling. Read More
The Biosimilars Council is arguing that the federal law governing biosimilars does not grant branded biologics an extra six months of exclusivity. Read More
Amgen neglected to provide Genentech with information on its manufacturing process for an Avastin biosimilar, violating statutory requirements, Genentech contends in a complaint. Read More