News & Analysis as of

Celltrion Drug Approvals

Goodwin

FDA Grants Interchangeability Designation to Fresenius Kabi’s and Celltrion’s Denosumab Biosimilars

Goodwin on

This week the FDA granted interchangeability status to Fresenius Kabi’s and Celltrion’s respective denosumab biosimilars.  Interchangeable biosimilars can be substituted for the reference product at the pharmacy without...more

Goodwin

European Commission Approves Celltrion’s AVTOZMA (CT-P47)

Goodwin on

​​​​​​​On February 23, 2025, Celltrion announced that the European Commission (“EC”) approved its tocilizumab biosimilar, AVTOZMA® (CT-P47), referencing Roche’s ROACTEMRA®....more

Goodwin

European commission approves Sandoz’s Rixathon® (rituximab)

Goodwin on

Sandoz announced today that it has received approval for the use of Rixathon® in Europe. Rixathon® is a biosimilar version of Roche’s MabThera® (rituximab) and is approved for use in all the same indications, including...more

3 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide