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The TGA approves 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.

Samsung Bioepis announces 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 i...

Prestige BioPharma and Teva Israel announce 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 Is...

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 leve...

Samsung Bioepis announces it has commenced Ph I trials for SB16 (proposed denosumab biosimilar).

Significant biosimilar activities this week include

05 Nov 20 | Teva released its Q3 2020 financial results, reporting a 2% increase in generic and biosimilar revenues in North America compared to Q3 2019. Teva attributed this increase in part to higher revenues from...

Formycon and Bioeq announce they have commenced dosing in Ph III trials of FYB202 (proposed ustekinumab biosimilar) in patients with moderate to severe plaque psoriasis.

Shanghai Henlius Biotech announces it has commenced Ph I trials for HLX14 (proposed denosumab biosimilar).

CSL confirmed it will commence manufacturing AZD1222 (AZ/Oxford vaccine) on 09 November 2020. The product will be manufactured at its facility in Broadmeadows, Victoria, in eight large scale batches over 2020-21.

Biocon Biologics announces 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 manufa...