5 February 2025 The US Food and Drug Administration (FDA) has approved Susvimo (ranibizumab injection) 100mg/mL for the treatment of diabetic macular edema (DME), said Swiss pharma giant Roche.
The US Food and Drug Administration (FDA) has approved Avtozma (CT-P47, tocilizumab-anoh) in both an intravenous (IV) and subcutaneous (SC) formulation as a biosimilar to Actemra, developed by South Korean firm Celltrion. 3 February 2025
US biotech major Amgen =announced that it has reached resolution of its patent infringement litigation related to South Korea-based Celltrion’s denosumab biosimilar products, Amgen brands Prolia and Xgeva. 29 January 2025
Formycon and its commercialization partner, fellow German firm Fresenius Kabi, have received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Otulfi (ustekinumab). 15 January 2025
Teva Pharmaceuticals has partnered with Klinge Biopharma and Formycon to commercialize FYB203, a biosimilar to Eylea (aflibercept), in Europe and Israel. 13 January 2025
South Korean biosimilars developer Samsung Bioepis and Israel’s Teva Pharmaceutical Industries have entered into a license, development and commercialization agreement for Epysqli (eculizumab-aagh), Samsung Bioepis’ copy of Soliris (eculizumab), in the USA. 11 January 2025
Taiwan-based GlycoNex, a biotech company focused on the development of glycan-directed cancer immunotherapies, has announced a licensing agreement for its denosumab biosimilar, SPD8. 6 January 2025
The US Food and Drug Administration (FDA) has approved Steqeyma (ustekinumab-stba), a biosimilar to Johnson & Johnson’s Stelara, from South Korea’s Celltrion. 18 December 2024
South Korea has emerged as a global leader in the biopharmaceutical industry, driven by its advanced clinical research infrastructure and government support. 18 December 2024
The European Medicines Agency’s (EMA) human medicines committee (CHMP) adopted positive opinions for six biosimilar medicines at its December meeting. 14 December 2024
The HSE University BRICS Competition Law and Policy Centre has summarized the first results of its annual analytical study on bringing biologics to the BRICS market. 13 December 2024
Germany’s Formycon has entered into a licensing and supply agreement with MS Pharma for the commercialization of FYB202, Formycon’s biosimilar to Johnson & Johnson’s Stelara (ustekinumab), in the Middle East and North Africa (MENA region). 9 December 2024
A surge in biologics losing market exclusivity creates an opportunity to increase access to treatment, free up vital healthcare resources, enhance budget sustainability thanks to effective market competition. 6 December 2024
Accord BioPharma, a specialty division of Intas Pharmaceuticals, has entered into an agreement to acquire Coherus BioSciences’ Udenyca (pegfilgrastim-cbqv) business. 4 December 2024
Biocon Biologics the biosimilars company and subsidiary of Indian drugmaker Biocon, has announced that the US Food and Drug Administration (FDA) has approved Yesintek (ustekinumab-kfce), a biosimilar to the reference product, Stelara (ustekinumab) from Johnson & Johnson. 2 December 2024
Samsung Bioepis has appointed Kyung-Ah Kim as its new president and chief executive, succeeding Christopher Hansung Ko, who will lead the Samsung Future Business Division. 27 November 2024
Sweden-based Xbrane Biopharma and Intas Pharmaceuticals have announced an exclusive global licensing and co-development agreement for the former company’s Opdivo (nivolumab) biosimilar candidate. 20 November 2024
Following US approval in May this year, South Korea’s Samsung Bioepis and US biotech Biogen have now won approval from the European Commission (EC) for their Opuviz 40mg/mL solution for injection in a vial, a biosimilar referencing Regeneron and Bayer’s Eylea (aflibercept). 18 November 2024
South Korean biosimilars company Celltrion today announced its acquisition of iQone Healthcare Switzerland a specialty pharmaceutical company focused on distribution, sales, and marketing in Switzerland. 15 November 2024
Swiss generic and biosimilar medicines major Sandoz today announced that the European Commission (EC) has granted marketing authorization for Afqlir (aflibercept) 2mg vial kit and pre-filled syringe for intravitreal injection. 15 November 2024
The US Food and Drug Administration (FDA) has approved Avtozma (CT-P47, tocilizumab-anoh) in both an intravenous (IV) and subcutaneous (SC) formulation as a biosimilar to Actemra, developed by South Korean firm Celltrion. 3 February 2025
US biotech major Amgen =announced that it has reached resolution of its patent infringement litigation related to South Korea-based Celltrion’s denosumab biosimilar products, Amgen brands Prolia and Xgeva. 29 January 2025
Formycon and its commercialization partner, fellow German firm Fresenius Kabi, have received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Otulfi (ustekinumab). 15 January 2025
Teva Pharmaceuticals has partnered with Klinge Biopharma and Formycon to commercialize FYB203, a biosimilar to Eylea (aflibercept), in Europe and Israel. 13 January 2025
South Korean biosimilars developer Samsung Bioepis and Israel’s Teva Pharmaceutical Industries have entered into a license, development and commercialization agreement for Epysqli (eculizumab-aagh), Samsung Bioepis’ copy of Soliris (eculizumab), in the USA. 11 January 2025
Taiwan-based GlycoNex, a biotech company focused on the development of glycan-directed cancer immunotherapies, has announced a licensing agreement for its denosumab biosimilar, SPD8. 6 January 2025
The US Food and Drug Administration (FDA) has approved Steqeyma (ustekinumab-stba), a biosimilar to Johnson & Johnson’s Stelara, from South Korea’s Celltrion. 18 December 2024
South Korea has emerged as a global leader in the biopharmaceutical industry, driven by its advanced clinical research infrastructure and government support. 18 December 2024
The European Medicines Agency’s (EMA) human medicines committee (CHMP) adopted positive opinions for six biosimilar medicines at its December meeting. 14 December 2024
The HSE University BRICS Competition Law and Policy Centre has summarized the first results of its annual analytical study on bringing biologics to the BRICS market. 13 December 2024
Germany’s Formycon has entered into a licensing and supply agreement with MS Pharma for the commercialization of FYB202, Formycon’s biosimilar to Johnson & Johnson’s Stelara (ustekinumab), in the Middle East and North Africa (MENA region). 9 December 2024
A surge in biologics losing market exclusivity creates an opportunity to increase access to treatment, free up vital healthcare resources, enhance budget sustainability thanks to effective market competition. 6 December 2024
Accord BioPharma, a specialty division of Intas Pharmaceuticals, has entered into an agreement to acquire Coherus BioSciences’ Udenyca (pegfilgrastim-cbqv) business. 4 December 2024
Biocon Biologics the biosimilars company and subsidiary of Indian drugmaker Biocon, has announced that the US Food and Drug Administration (FDA) has approved Yesintek (ustekinumab-kfce), a biosimilar to the reference product, Stelara (ustekinumab) from Johnson & Johnson. 2 December 2024
Samsung Bioepis has appointed Kyung-Ah Kim as its new president and chief executive, succeeding Christopher Hansung Ko, who will lead the Samsung Future Business Division. 27 November 2024
Sweden-based Xbrane Biopharma and Intas Pharmaceuticals have announced an exclusive global licensing and co-development agreement for the former company’s Opdivo (nivolumab) biosimilar candidate. 20 November 2024
Following US approval in May this year, South Korea’s Samsung Bioepis and US biotech Biogen have now won approval from the European Commission (EC) for their Opuviz 40mg/mL solution for injection in a vial, a biosimilar referencing Regeneron and Bayer’s Eylea (aflibercept). 18 November 2024
South Korean biosimilars company Celltrion today announced its acquisition of iQone Healthcare Switzerland a specialty pharmaceutical company focused on distribution, sales, and marketing in Switzerland. 15 November 2024
Swiss generic and biosimilar medicines major Sandoz today announced that the European Commission (EC) has granted marketing authorization for Afqlir (aflibercept) 2mg vial kit and pre-filled syringe for intravitreal injection. 15 November 2024