Pearce IP BioBlast: w/e 26 June 2020

Significant biosimilar activities this week include:

  • June 2020: the NZ Herald reported a new study by NZ scientists which indicates that transgenic goats are capable of producing milk with high levels of cetuximab.

  • June 22: Ankylosing Spondylitis News reported new data from Germany indicates Simponi® (golimumab) is an effective therapy for people with ankylosing spondylitis and other chronic inflammatory conditions, regardless of pre-treatment with other TNF inhibitors.


  • June 25: Sandoz launched its 'Biosimilars Generation' campaign, aimed to help Canadians better understand the benefits of biosimilars, their safety and efficacy, and the opportunities for cost savings.  The campaign includes a new website aimed at supporting and educating Canadians.


  • June 25: Aptevo Therapeutics announced it will receive quarterly "low single digit" fixed royalty payments from Pfizer (Wyeth) for 7 years from the first launch of Ruxience® (biosimilar rituximab).  The original royalty agreement was signed by Trubion Pharmaceuticals which was then acquired by Aptevo's spin-off Emergent BioSolutions, and Wyeth, in 2016.  The royalty is applied to net sales in the US, EU and Japan.

  • June 26: Samsung Bioepis announced the CHMP has adopted a positive opinion for Aybintio® (biosimilar bevacizumab).

  • June 26: Janssen announced it has discontinued its Ph III LOTUS study of Stelara® (ustekinumab) in Systematic Lupus Erythematosus due to lack of efficacy.

  • June 27: Shanghai Henlius Biotech announced the Investigational New Drug application for HLX14 (biosimilar denosumab) has been approved by China's NMPA for the treatment of postmenopausal osteoporosis.

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August 19, 2020

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