Significant biosimilar activities this week include:
05 Nov 20: Formycon announced its BLA resubmission strategy for FYB201 (proposed ranibizumab biosimilar) has been adjusted. The approval will now be requested directly for a large commercial scale, which Formycon and Bioeq expect will simplify the approval procedure.
07 Nov 20: Biocon Biologics announced it has approved a USD 150 million capital injection from Goldman Sachs. Dr Christiane Hamacher (CEO of Biocon Biologics) announced that this capital injection will enable Biocon Biologics to make prudent investments in R&D, high-quality manufacturing and establishing a global commercial footprint.
09 Nov 20: Shanghai Henlius Biotech announced it has commenced Ph I trials for HLX14 (proposed denosumab biosimilar).
09 Nov 20: Formycon and Bioeq announced they have commenced dosing in Ph III trials of FYB202 (proposed ustekinumab biosimilar) in patients with moderate to severe plaque psoriasis.
10 Nov 20: Samsung Bioepis announced it has commenced Ph I trials for SB16 (proposed denosumab biosimilar).
10 Nov 20: Prestige BioPharma and Teva Israel announced they have entered into an exclusive partnership and supply agreement for Prestige's Tuznue® (trastuzumab biosimilar) in Israel. Under the agreement, Prestige is responsible for registration and commercial supply, and Teva Israel will be responsible for local registration, sales and marketing in Israel.
10 Nov 20: researchers from two Pfizer-sponsored studies reported successful, first-time tests of a multibiomarker disease activity score in patients with rheumatoid arthritis. The studies examined Pfizer's adalimumab and infliximab biosimilars, finding that serum biomarker levels tracked one another closely between biosimilar and reference cohorts reducing the need for physical examinations.
12 Nov 20: Samsung Bioepis announced one-year results from Ph III study of SB11 (proposed ranibizumab biosimilar) at the American Academy of Ophthalmology 2020 Virtual. Samsung reported the data confirms equivalence in efficacy and pharmocokinetics as well as a comparable safety and immunogenicity profile.
12 Nov 20, EU: the CHMP adopted a positive opinion for the marketing approval for Samsung Bioepis' Onbevzi® (biosimilar bevacizumab). Onbevzi® will be available as a 25mg/mL concentrate for solution for infusion, and is indicated for the treatment of carcinoma or the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.
12 Nov 20, AU: the TGA approved Celltrion's subcutaneous "biobetter" infliximab product Remsima in auto-injection pen and PFS presentations. This is the first subcut infliximab product to be approved in Australia.