Pearce IP BioBlast: w/e 06 November 2020

Significant biosimilar activities this week include:

  • 05 Nov 20: Teva released its Q3 2020 financial results, reporting a 2% increase in generic and biosimilar revenues in North America compared to Q3 2019. Teva attributed this increase in part to higher revenues from Truxima® (biosimilar rituximab), which has been reported to have gained 20.6% of the market share within its first year of launch.
     

  • 05 Nov 20: Pharma Intelligence announced the Global Generics & Biosimilars Digital Awards Winners. Alvogen, Accord Healthcare, Aurobindo, STADA, Dr Reddy's Laboratories, Samsung Bioepis, and Richard Saynor of Sandoz were among the winners.
     

  • 04 Nov 20, CA: Amgen received three Notices of Compliance (NOC) from Health Canada relating to Amgevita® (50mg/mL biosimilar adalimumab). This follows Fresenius Kabi's NOC relating to its biosimilar adalimumab (also 50mg/mL), Idacio® on 30 October 2020.
     

  • 04 Nov 20, EU: Medicines for Europe released a white paper which reviews the barriers to generic and biosimilar market entry.  In particular, the unlimited number of divisional patents which can be filed in the EU, product hopping and anticompetitive rebates were identified as significant barriers to market entry for generics and biosimilars.
     

  • 04 Nov 20: Alvotech announced it has entered into an exclusive partnership with Cipla for two oncology biosimilars and three auto-immune biosimilars in South Africa. Under the agreement, Alvotech will be responsible for the development and supply of the products, while Cipla will be responsible for registration and commercialisation.
     

  • 03 Nov 20: Celltrion announced the results of Ph III studies of CT-P17 (proposed adalimumab biosimilar) demonstrate comparable efficacy and safety against reference adalimumab in rheumatoid arthritis.
     

  • 03 Nov 20, EU: Hindu Business Line reported Strides Pharma has filed a submission with the EMA for PTH (proposed teriparatide biosimilar).

 

 

 

 

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Biosimilars Bulletin 

November 9, 2020

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