Pearce IP BioBlast: w/e 29 May 2020

Significant biosimilar activities this week include:

  • May 25: the American Journal of Managed Care reported two cost savings studies presented at a virtual meeting of the International Society for Pharmacoeconomics and Outcomes Research.  The studies, which were sponsored by Pfizer, analysed the potential cost savings over a three year period from a US perspective in switching to bevacizumab and rituximab biosimilars.  The studies concluded that over three years $14.7 million could be saved on bevacizumab used to treat 503-676 patients, with $3.8 million saved on rituximab used to treat 754-764 patients. 

     

  • May 27: Fresenius Kabi announced that the FDA has accepted its BLA for MSB 11455, a proposed pegfilgrastim biosimilar. 

     

  • May 27: Pulse News reported that AProgen had doubled its production capacity with the addition of two new perfusion production lines, increasing total output capacity to 240,000 litres of culture fluid per cycle.  AProgen currently has adalimumab, infliximab, trastuzumab, etanercept, cetuximab and bevacizumab biosimilars under development.

     

     

  • May 27: Henlius Biotech announced that China's National Medical Products Administration has approved its IND application for HLX14, a proposed denosumab biosimilar.  Henlius also announced that its adalimumab and trastuzumab products are under New Drug Application review, with the potential to be launched in 2020.

     

  • May 29: Fresenius Kabi announced it had signed an agreement with Medac to cooperate in Germany in the area of treatments for rheumatic illnesses.  From 01 June 2020, Medac's sales representatives will be able to offer Fresenius Kabi's adalimumab biosimilar Idacio.  Medac is already a provider of methotrexate, a product which is often used in combination with adalimumab.

     

  • May 29: the Centre for Biosimilars reported that two new studies for HD201 (Prestige Biopharma's proposed trastuzumab biosimilar) were presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology.  The first study, TROIKA-I demonstrated that HD201 was safe and well tolerated with PK comparability to the originator.  The second, TROIKA was designed to compare safety, PK and efficacy based on the total pathological complete response rate.  The investigators reported that the studies demonstrated equivalence between the biosimilar and reference products.

     

  • May 29: Nanobiotix announced positive first results from Ph I trials of NBTXR3. NBTXR3 is being developed as a first-in-class product to treat locally advanced head and neck squamous cell carcinoma in elderly patients unable to receive chemotherapy or cetuximab.

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August 19, 2020

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