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The Prime Minister’s office announced the Australian Government has signed a Letter of Intent with AstraZeneca for the supply of the University of Oxford’s COVID-19 vaccine candidate AZD1222. If trials prove successful, safe and effective, it is expected that ev...

Merck announces the results of Ph III trials of Keytruda® (pembrolizumab) in combination with chemotherapy for first-line treatment of patients with locally advanced or metastatic esophageal cancer. Merck reported that Keytruda® met the primary and secondary endpoints and t...

Sandoz Canada announces it has entered an agreement with the Pan-Canadian Pharmaceutical Alliance (pCPA) regarding biosimilar medicines Ziextenzo® (biosimilar pegfilgrastim) and Riximyo® (biosimilar rituximab). Both products were approved by Health Canada in late April 2020...

CSL confirmed the development of the University of Queensland’s (UQ) vaccine candidate remains its priority. CSL also disclosed that it has entered discussions with AstraZeneca and the Australian Government to assess whether it can provide local manufacturing support ...

The Irish Pharmacy Union (IPU) called upon the Irish Minister for Health to change legislation to enable substitution of biosimilars at the pharmacy level in Ireland. The IPU stated that €370 million in potential savings has been foregone since 2017, and that substitution i...

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.