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Significant biosimilar activities this week include
05 Aug 20 | In its Q4 FY20 earnings call, Aurobindo Pharma announced that its wholly owned subsidiary CuraTeQ Biologics intends to file applications for two of its biosimilar products in EU at the end of 2020 or star...

Shanghai Henlius Biotech announces China’s NMPA has approved its trastuzumab biosimilar HANQUYOU. HANQUYOU is indicated for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer.

The Centre for Biosimilars reports that Celltrion has refuted the claims of a July 2020 study which critiqued the methods used by Celltrion and the FDA to determine whether Remsima® (biosimilar infliximab) was equivalent to Remicade®. Among its critiques of the study, Cellt...

Korea Biomedical Review reports that Celltrion will commence Ph I clinical trials of CT-P41 (biosimilar denosumab candidate) in September.

In an online press conference, Samsung Biologics announced it plans for a fourth manufacturing plant within the year. This new US $2 billion plant will have 256KL capacity, with manufacturing activities scheduled to commence in the second half of 2022.

The Centre for Biosimilars reports that Polpharma is planning to file a modified application for FYB201 (biosimilar ranibizumab candidate) to the FDA within the next year.

Docwirenews reports a new post-approval safety surveillance study of Janssen’s golimumab Simponi® demonstrated that there is no association between exposure to golimumab and an increased risk of prespecified outcomes.

Samsung Bioepis launches Ontruzant® (biosimilar trastuzumab) in Brazil. Ontruzant® is indicated for the treatment of metastatic HER2-overexpressing breast cancer, early HER2-overexpressing breast cancer, and advanced gastric cancer.