Biosimilars

Alvotech and Dr. Reddy’s Report the US FDA’s BLA Acceptance for AVT03 (Biosimilar, Prolia and Xgeva)

Alvotech and Dr. Reddy’s Report the US FDA’s BLA Acceptance for AVT03 (Biosimilar, Prolia and Xgeva)

Shots: The US FDA has accepted 351(k) BLA of AVT03, a biosimilar version of Prolia...

Celltrion launches SteQeyma (Biosimilar, Stelara) in the US

Celltrion launches SteQeyma (Biosimilar, Stelara) in the US

Shots: Celltrion has launched SteQeyma (ustekinumab-stba) injection, a biosimilar...

Celltrion’s Omlyclo (Biosimilar, Xolair) Secures the US FDA’s Approval

Celltrion’s Omlyclo (Biosimilar, Xolair) Secures the US FDA’s Approval

Shots: The US FDA has approved & granted interchangeability designation to Oml...

Celltrion Reports the US FDA approval for Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)

Celltrion Reports the US FDA approval for Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)

Shots: The US FDA has approved Stoboclo & Osenvelt (CT-P41, denosumab), a bios...

Formycon Reports the MHRA’s Approval of FYB203 (Biosimilar, Eylea) as Ahzantive

Formycon Reports the MHRA’s Approval of FYB203 (Biosimilar, Eylea) as Ahzantive

Shots:  Following the EC approval, Formycon & Klinge Biopharma have repor...

Sandoz Launches Pyzchiva (Biosimilar, Ustekinumab-ttwe) in the US for Chronic Inflammatory Diseases

Sandoz Launches Pyzchiva (Biosimilar, Ustekinumab-ttwe) in the US for Chronic Inflammatory Diseases

Shots: Sandoz has launched Pyzchiva, a biosimilar version of Stelara in the US to...

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