An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

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 ...

Off-patent medicines provide people with access to high-quality essential treatment options that can be significantly less expensive than branded on-patent medicines. Off-patent therapies — generics ...

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 ...

Generic and biosimilar drugs are becoming more expensive and less accessible to patients because of their formulary placement, according to Drug Topics. Pharmacy benefit managers are increasingly ...