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 Newsreported 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: Sandozlaunched 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 Therapeuticsannounced 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 Bioepisannounced 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 Biotechannounced the Investigational New Drug application for HLX14 (biosimilar denosumab) has been approved by China's NMPA for the treatment of postmenopausal osteoporosis.