Pearce IP BioBlast: w/e 04 September 2020

Significant biosimilar activities this week include:

  • 31 Aug 20, US: Mylan and Biocon announced the launch of Semglee® (insulin glargine) in vial and pre-filled pen presentations in the US.   Semglee® is indicated for the treatment of adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes.
     

  • 01 Sep 20: NeuClone Pharmaceuticals disclosed it is working on biosimilars referencing Opdivo® (nivolumab) and Keytruda® (pembrolizumab).  The products are in the advanced stages of pre-clinical development and are being developed in partnership with the Serum Institute of India.
     

  • 01 Sep 20: a new study examining the analytical and functional similarity of Amgen/Allergan's proposed rituximab biosimilar ABP798 concludes that it is highly analytically similar to Rituxan®.  
     

  • 01 Sep 20: Generics Bulletin reported Xbrane is aiming to file an application for Xlucane® (biosimilar ranibizumab) in Europe and the US, and to license the product in Latin America, Japan and China in the next 12 months.
     

  • 03 Sep 20: Bio-Thera Solutions commenced dosing in Ph I clinical trials of BAT2206 (proposed ustekinumab biosimilar).
     

  • 03 Sep 20: Innovent Biologics announced China's NMPA has approved Sulinno® (biosimilar adalimumab) for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis.
     

  • 03 Sep 20: Lupus Foundation of Australia reported a new study demonstrates that rituximab may prove effective as a treatment option for refractory lupus.  The study was conducted in 147 people with lupus, and found that six months after the first treatment, 45% of patients demonstrated a complete response to therapy, with another 28% demonstrated some improvement in disease activity.
     

  • 03 Sep 20: Targeted Oncology reported the results of a Ph III trial of Samsung Bioepis' proposed bevacizumab biosimilar, SB8.   The researchers reported that the objective response rate ratio of SB8 and bevacizumab appeared equivalent, with comparable safety, pharmacokinetics and immunogenicity as a treatment of patients with metastatic or recurrent nonsquamous non-small cell lung cancer.

 

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Biosimilars Bulletin 

August 19, 2020

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