Accord BioPharma’s Hercessi 420mg (Biosimilar, Herceptin) Receives the US FDA’s Approval to Treat Various HER2-Overexpressing Cancer

Shots: The US FDA has granted approval to the company’s Hercessi (420mg), a biosimilar version of Herceptin (trastuzumab), for the treatment of HER2-overexpressing breast & G/GEJ adenocarcinoma. It is planned to be introduced in early 2025 The approval was supported by the analytical, preclinical & clinical data showing similarity b/w Hercessi & Herceptin from…

ByDipanshu DixitSeptember 18, 2024

Accord BioPharma Reports US FDA’s Acceptance of BLA for DMB-3115 (Biosimilar, Stelara)

Shots : The US FDA has accepted the BLA for DMB-3115 based on the results from P-III multi-regional studies for treating plaque psoriasis having rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms as its 1EP. The results showed similar quality, safety and efficacy between DMB-3115 vs Stelara Accord BioPharma…

ByDipanshu DixitJanuary 4, 2024

Insights+ Key Biosimilars Events of April 2023

Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of April, Sandoz’s Hyrimoz (biosimilar, adalimumab) received EC’s…

BySenior EditorMay 3, 2023

Accord BioPharma’s Hercessi 420mg (Biosimilar, Herceptin) Receives the US FDA’s Approval to Treat Various HER2-Overexpressing Cancer

Accord BioPharma Reports US FDA’s Acceptance of BLA for DMB-3115 (Biosimilar, Stelara)

Insights+ Key Biosimilars Events of April 2023

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