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13 March 2025 Ireland-based Mallinckrodt Pharmaceuticals and Endo Inc have agreed to combine in a stock and cash deal worth $6.7 billion, after the pair emerged from bankruptcy processes linked to liabilities over the US opioid crisis.
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Biosimilars
South Korea’s Celltrion has announced the US launch of Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab), following approval by the US Food and Drug Administration (FDA) in December 2024. 13 March 2025
Biosimilars
US pharma major Bristol Myers Squibb has announced positive data from the pivotal Phase III POETYK PsA-2 trial evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). 10 March 2025
Biosimilars
On Friday, the US Food and Drug Administration (FDA) approved as the first interchangeable biosimilar to Swiss pharma giant Roche's
anti-IgE monoclonal antibody Xolair (omalizumab). 8 March 2025
Biosimilars
Swiss generics and biosimilars giant Sandoz today announced financial results for the full year 2024, showing that sales were $10.4 billion, up by 9% in constant currencies (+7% in $). 5 March 2025
Biosimilars
South Korea-based Celltrion today announced that the US Food and Drug Administration (FDA) has approved Stoboclo and Osenvelt (CT-P41, denosumab-bmwo), biosimilars referencing Amgen’s Prolia and Xgeva brands respectively for all indications of the reference products. 4 March 2025
Biosimilars
Johnson & Johnson has taken legal action against Samsung Bioepis, accusing the South Korean biotech of violating a settlement agreement by authorizing a third party to market a private-label biosimilar version of Stelara (ustekinumab). 27 February 2025
Biosimilars
South Korean firm Celltrion announced that the European Commission (EC) has granted marketing authorization for Avtozma (CT-P47), a biosimilar referencing RoActemra (tocilizumab), which is marketed by Swiss pharma giant Roche. 25 February 2025
Biosimilars
Swiss generics and biosimilars major Sandoz has announced the launch of Pyzchiva (ustekinumab-ttwe) in the USA. From today, the medicine is commercially available to patients across the USA. 24 February 2025
Biosimilars
South Korean biosimilars developer Celltrion late yesterday announced new post-hoc analyses of its pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC), at the 20th European Crohn’s and Colitis Organisation (ECCO) Congress, showcasing the treatment’s effectiveness across a range of key clinical outcomes in inflammatory bowel disease (IBD). 21 February 2025
Biosimilars
South Korea-based Celltrion today announced that the European Commission (EC) has granted marketing authorization for three products across two biosimilars. 20 February 2025
Biosimilars
Formycon’s shares edged up 2.4% to 30.60 euros as it revealed it is presenting an overview of the comparative data of the ustekinumab biosimilar FYB202 at this year's Congress of the European Crohn's and Colitis Organization (ECCO), now taking place in Berlin, Germany. 20 February 2025
Biosimilars
Icelandic biosimilar company Alvotech and Israeli drugmaker Teva Pharmaceuticals have announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, a proposed biosimilar to Eylea (aflibercept). 19 February 2025
Biosimilars
South Korean biosimilars company Samsung Bioepis has announced that the US Food and Drug Administration (FDA) and European Commission (EC) have approved Ospomyv (denosumab-dssb; 60 mg pre-filled syringe) and Xbryk (denosumab-dssb; 120 mg vial). 17 February 2025
Biosimilars
Germany’s Formycon has decided today to prematurely terminate the Phase III trial (Lotus) for its biosimilar candidate FYB206. 17 February 2025
Biosimilars
The US Food and Drug Administration has approved Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart), from Denmark’s Novo Nordisk, for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. 17 February 2025
Biosimilars
Dr Reddy’s Laboratories has signed a licensing deal with Shanghai Henlius Biotech to develop and commercialize HLX15, a biosimilar of Johnson & Johnson’s Darzalex (daratumumab) for multiple myeloma. 7 February 2025
Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
Teva Pharmaceuticals has partnered with Klinge Biopharma and Formycon to commercialize FYB203, a biosimilar to Eylea (aflibercept), in Europe and Israel. 13 January 2025
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Biosimilars
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
Biosimilars
The US Food and Drug Administration approved 50 novel drugs in 2024, continuing to outpace its global regulatory peers. 10 January 2025
Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
The European Medicines Agency’s (EMA) human medicines committee (CHMP) adopted positive opinions for six biosimilar medicines at its December meeting. 14 December 2024
Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
Accord BioPharma, a specialty division of Intas Pharmaceuticals, has entered into an agreement to acquire Coherus BioSciences’ Udenyca (pegfilgrastim-cbqv) business. 4 December 2024
Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
Korean biosimilar company Celltrion is showing that it can also achieve success with a novel biologic. 1 November 2024
Biosimilars
The US unit of South Korea-based biosimilar drug developer Celltrion
has announced a late-breaking post hoc analysis of the pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC) of Zymfentra (infliximab-dyyb), during the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. 30 October 2024
Biosimilars
Indian drugmaker Biocon subsidiary Biocon Biologicals has released a new extension study evaluating MYL-1701P, a proposed biosimilar to ophthalmic drug aflibercept. 24 October 2024
Biosimilars
Iceland-based Alvotech and the US unit of Israel’s of Teva Pharmaceutical Industries today revealed that that the US Food and Drug Administration (FDA) has approved Selarsdi (ustekinumab-aekn) in a new presentation 22 October 2024
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