01 May 21 | Samsung Bioepis announced a new study demonstrating the structural, physicochemical and biological similarity between its SB11 (proposed ranibizumab biosimilar) and Lucentis®. The BLA and MA for SB11 are currently before the FDA and EMA respectively.
03 May 21 | Sandoz announced it will commence enrolling patients in MYLIGHT, its Ph III efficacy and safety study of its proposed aflibercept biosimilar. MYLIGHT will assess the efficacy and safety of the biosimilar candidate in comparison to Eylea® in patients with neovascular age-related macular degeneration.
03 May 21 | Merck reported the vision, focus and business model for its new standalone company, Organon. Merck disclosed that Organon with have a direct sales presence in 58 markets, with key growth drivers in Organon’s biosimilars portfolio expected to be Renflexis® (biosimilar infliximab), Aybintio® (biosimilar bevacizumab) and Hadlima® (biosimilar adalimumab).
04 May 21 | CA | Amgen launched Amgevita® (biosimilar adalimumab) in Canada. Amgevita® is available in 50mg/mL PFS and pen presentations and is citrate-free. Amgevita® will be reimbursed on the public drug plans in BC, Alberta, Ontario, Quebec, New Brunswick and Newfoundland.
05 May 21 | IN | ThePrint reported that Hetero Labs has submitted an application to start clinical trials and manufacture of biosimilar tocilizumab in India. Tocilizumab has been recommended for off-label use in the treatment of COVID-19 by the Indian Government, but has been subject to extreme shortages. The product is manufactured by Roche and distributed in India by Cipla pharmaceuticals. It is not known whether Hetero has reached a licensing agreement with Roche.
06 May 21 | CA | The Government of Alberta announced it has expanded its biosimilars switching program to include adalimumab for all originator indications except pediatric juvenial idiopathic arthritis. All adult patients on Humira® will be switched to Amgevita®, Hadlima®, Hulio®, Hyrimoz® or Idacio® by 01 May 2022. This follows extensions made to biosimilar switching programs by British Columbia and New Brunswick last month.
06 May 21 | Coherus BioSciences reported its Q1 2021 financial results. Coherus disclosed that it has commenced the rolling submission of the BLA for toripalimab and that it expects to file the BLA for CHS-201 (proposed ranibizumab biosimilar) mid-2021.