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Insights+ Key Biosimilars Events of February 2023

Insights+ Key Biosimilars Events of February 2023

March 1, 2023

Merck Reports P-III Trial (KEYNOTE-671) of Keytruda for Resectable Stage II, IIIA or IIIB Non-Small Cell Lung Cancer

Merck Reports P-III Trial (KEYNOTE-671) of Keytruda for Resectable Stage II, IIIA or IIIB Non-Small Cell Lung Cancer

March 1, 2023

Bayer Submits Application to MHLW for Marketing Authorization of Aflibercept in Japan

Bayer Submits Application to MHLW for Marketing Authorization of Aflibercept in Japan

March 1, 2023

BMS Reports the US FDA Acceptance of sBLA and EMA’s Validation of MAA for Opdivo (nivolumab) to Treat Stage IIB or IIC Melanoma

BMS Reports the US FDA Acceptance of sBLA and EMA’s Validation of MAA for Opdivo (nivolumab) to Treat Stage IIB or IIC Melanoma

March 1, 2023

Reata Pharmaceuticals’ Skyclarys (omaveloxolone) Receives the US FDA’s Approval for the Treatment of Friedreich’s Ataxia

Reata Pharmaceuticals’ Skyclarys (omaveloxolone) Receives the US FDA’s Approval for the Treatment of Friedreich’s Ataxia

March 1, 2023

Orion’s Darolutamide Receives EC’s Marketing Authorisation for the Treatment of Prostate Cancer

Orion’s Darolutamide Receives EC’s Marketing Authorisation for the Treatment of Prostate Cancer

March 1, 2023

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