Biosimilars

ARTICLES

With 1 biosimilar already approved in the US, the FDA has finally released draft guidelines for naming these new products.
The Biosimilars Council wants CMS to hold back on Medicare Part B reimbursement for biosimilars.
A US appeals court has blocked Novartis from selling the first biosimilar to be approved in the United States.
Will Sandoz' biosimilar, first ever in the US, ever see the light of day?
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.

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