Significant biosimilar activities this week include:
11 Aug 20: in an online press conference, Samsung Biologicsannounced it plans for a fourth manufacturing plant within the year. This new US $2 billion plant will have 256KL capacity, with manufacturing activities scheduled to commence in the second half of 2022.
17 Aug 20: the Irish Pharmacy Union (IPU) calledupon the Irish Minister for Healthto change legislation to enable substitution of biosimilars at the pharmacy level in Ireland. The IPU stated that €370 million in potential savings has been foregone since 2017, and that substitution is a missed opportunity in the HPRA Biosimilars Guide.
19 Aug 20: Merckannounced the results of Ph III trials of Keytruda® (pembrolizumab) in combination with chemotherapy for first-line treatment of patients with locally advanced or metastatic esophageal cancer. Merck reported that Keytruda® met the primary and secondary endpoints and that the safety profile was consistent with that observed in previously reported studies.
19 Aug 20, CA: Sandoz Canadaannounced it has entered an agreement with the Pan-Canadian Pharmaceutical Alliance (pCPA) regarding biosimilar medicines Ziextenzo® (biosimilar pegfilgrastim) and Riximyo® (biosimilar rituximab). Both products were approved by Health Canada in late April 2020. Under the pCPA agreement, Riximyo® is reimbursed in Ontario (from July 2020) for certain indications, through Cancer Care Ontario. Additionally, British Columbia announced the reimbursement of Riximyo® (from August 2020) through BC Cancer.
20 Aug 20: Intract Pharma and Celltrionannounced an agreement to jointly develop the world's first oral antibody therapeutic for the treatment of IBD. The infliximab product has been cleared by the UK's MHRA to proceed to Ph 1b/2a clinical trials in patients with IBD during the second half of 2021.
20 Aug 20, EU: Samsung Bioepisannounced that the EC has granted marketing authorisation for Aybintio®, biosimilar bevacizumab (Avastin®) with a full indication set. EMA accepted Samsung's application on 19 July 2019, and CHMP positive opinion was granted on 26 June 2020. This is Samsung's 5th approved EU biosimilar, and the 3rd approved biosimilar to bevacizumab (following the approval of Amgen/Allergan's Mvasti® in January 2018 and Pfizer's Zirabev® in December 2018). Centus Biotherapeutics' application for Equidacent® follows Samsung's closely, having received CHMP positive opinion in July 2020.
21 Aug 20: pharmacy benefit manager Express Scripts released its 2021 national preferred formulary list. Among the changes made to the formulary is the removal of Neulasta® and Udenyca® from the preferred list.
21 Aug 20, AU: PBS published the outcomes of the July 2020 meeting including positive recommendations for three biosimilar products. Pfizer's application to PBS list its biosimilar bevacizumab (Zirabev®) under the same conditions as Avastin® was recommended, as was Merck’s application to broaden out the PBS reimbursed indications for its Hadlima® (biosimilar adalimumab). Merck’s Hadlima® was first granted PBS listing in 2018 for rheumatoid arthritis only. The expanded recommendation follows Sandoz’s positive recommendation for Hyrimoz® earlier this year, which included the same indications as Humira®. Apotex's application to PBS list its Enoxapo® (biosimilar enoxaparin) was also recommended for the same indications as Clexane®.