Read our latest updates & insights

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.

Significant biosimilar activities this week include
31 Jul 20 | US | Vizient has advised its member health groups to utilise biosimilars to hedge against drug price inflation and the impacts of COVID-19.  Vizient predicts that drug prices in the US will increase by 3....

AVEO Oncology releases its Q2 FY2020 earnings report. AVEO reported data from its Ph I study of ficlatuzumab and cetuximab in patients with advanced head and neck squamous cell carcinoma (HNSCC) demonstrated that the products have an acceptable safety profile and showed pro...