Pearce IP BioBlast: w/e 14 August 2020

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 start of 2021, with target EU launches following one year later.  Aurobindo also announced further biosimilar products are expected to enter Ph III trials in early 2021.
     

  • 07 Aug 20: Celltrion released its Q2 FY20 earnings report.  Celltrion reported an overall increase of 82.5% in year-to-year sales.  Celltrion also reported that it is "preparing" its US approval application for CT-P17 (biosimilar adalimumab candidate), following the filing of its application in the EU in March this year.  Remsima SC® remains in Ph III clinical trials in the US.
     

  • 10 Aug 20, BR: Samsung Bioepis launched 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.
     

  • 10 Aug 20: AVEO Oncology released 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 promising anti-tumour activity in a refractory HNSCC patient population.  AVEO also announced that it is evaluating the process to secure additional clinical manufacturing of ficlatuzumab to potentially enable a Ph III clinical trial in 2022.
     

  • 10 Aug 20: Healio reported a new article published in the Annals of the Rheumatic Diseases showed that ixekizumab demonstrated significantly greater joint and skin improvement than adalimumab among patients with psoriatic arthritis (PsA).  The 52 week SPIRIT trial assessed 566 adults with PsA who had not yet been treated with a biological disease-modifying anti-rheumatic drugs.
     

  • 11 Aug 20: Docwirenews reported 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. 
     

  • 11 Aug 20: the Centre for Biosimilars reported that Polpharma is planning to file a modified application for FYB201 (biosimilar ranibizumab candidate) to the FDA within the next year.  
     

  • 14 Aug 20, CN: Shanghai Henlius Biotech announced China's NMPA has approved its trastuzumab biosimilar Zercepac®.  Zercepac® is indicated for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer.
     

  • 14 Aug 20: Korea Biomedical Review reported that Celltrion will commence Ph I clinical trials of CT-P41 (biosimilar denosumab candidate) in September.
     

  • 14 Aug 20: The Centre for Biosimilars reported 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, Celltrion has argued that the study does not reflect the FDA review procedure and the principles of the regulatory guidelines.

 

 

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Biosimilars Bulletin 

August 19, 2020

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