August 28, 2015
With 1 biosimilar already approved in the US, the FDA has finally released draft guidelines for naming these new products.
August 26, 2015
The Biosimilars Council wants CMS to hold back on Medicare Part B reimbursement for biosimilars.
June 5, 2015
A US appeals court has blocked Novartis from selling the first biosimilar to be approved in the United States.
June 4, 2015
Will Sandoz' biosimilar, first ever in the US, ever see the light of day?
May 14, 2015
While the marketing of the first biosimilar to be approved in the US market, Zarxio, has been delayed due to a court order, the FDA is providing guidance to manufacturers to help them effectively navigate the process of product development.