Biosimilars have yet to achieve their main purpose: to reduce the costs of complex biological drugs, as generics do for small molecules. Multiple barriers, from development costs to the contracting ...

Anyone confusing biosimilars with small molecule generics in the U.S. has only to look at the FDA fee schedules to see a big difference between the two.

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...

The Biologics Price Competition and Innovation Act of (BPCI Act) of 2009 granted responsibility to the FDA for review and approval of a new class of pharmaceuticals referred to as “Biosimilars.” (1) ...

How long before the biosimilar market looks like the generics market? While still a relatively new area of biopharma, the biosimilar market has been getting more and more competitive, with huge ...

The Association for Accessible Medicines and its Biosimilars Council have released an analysis undertaken by the IQVIA Institute for Human Data Science on behalf of AAM assessing the impact of patent ...