Pearce IP BioBlast: w/e 28 August 2020

Significant biosimilar activities this week include:

  • 24 Aug 20, JP: Merck announced Keytruda® (pembrolizumab) has received two additional approvals from the Japanese Pharmaceuticals and Medical Devices Agency:

    • new indication for the treatment of patients whose tumours are PD-L1-positive, and have radically unresectable, advanced or recurrent esophageal squamous cell carcinoma; and 

    • an additional dosage regimen of 400mg every six weeks as an IV infusion over 30 minutes, across all adult indications.
       

  • 24 Aug 20, CN: Bio-Thera Solutions and BeiGene announced they have executed a license / distribution and supply agreement for BAT1706 (proposed bevacizumab biosimilar).  Subject to approval by Bio-Thera's shareholders in September, the agreement grants BeiGene the right to develop, manufacture and commercialise BAT1706 in mainland China, Hong Kong, Macau and Taiwan in return for milestone payments totalling US$165M, and tiered double-digit royalties on future net product sales. 
     

  • 26 Aug 20, DE: Lupin and Mylan launched Nepexto® (biosimilar etanercept) in Germany.  Nepexto® is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, severe axial spondyloarthritis and plaque psoriasis.
     

  • 26 Aug 20:  Multiple Sclerosis News Today reported a new real-life study demonstrates that Ocrevus® (ocrelizumab) carries a higher risk of infections but carries a lower risk of cancer and immune reactions than rituximab in patients with multiple sclerosis.
     

  • 26 Aug 20, US: the Midwest Business Group on Health (MBGH) issued a call to action on biosimilars.  In this call to action, the MBGH highlighted the missed opportunities for cost savings amid the ever increasing costs for biologic drugs.
     

  • 27 Aug 20: Rheumatology Advisor reported a study sponsored by China's National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation demonstrates that delayed administration of subsequent denosumab doses by greater than 16 weeks is associated with increased risk for vertebral fracture.  This risk was observed in both the short delay (4-16 weeks) and the long delay (>16 weeks) groups.  Additionally, there was a significant correlation between delayed subsequent injections and major osteoporotic fractures.
     

  • 28 Aug 20, IN: Cadila Pharmaceuticals launched Cadalimab® (biosimilar adalimumab) in India.  Cadalimab® is available in 40mg/0.8mL injection and is indicated for rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis.  This is the fourth biosimilar launch in India by Cadila within 2 months following Bevaro® (biosimilar bevacizumab), Ritucad® (biosimilar rituximab) and NuPTH® (biosimilar teriparatide).
     

  • 28 Aug 20: Healio reports the results of the UK Kings College/NHS Trust MERLOT trial demonstrated there was no benefit to epimacular brachytherapy  as an adjunct to anti-VEGF injections, the results of which were worse than ranibizumab monotherapy, for the treatment of neovascular age-related macular degeneration.

 

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Biosimilars Bulletin 

August 19, 2020

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