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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
The European Commission (EC) granted marketing authorization for Tyruko (natalizumab), the first and only biosimilar multiple sclerosis drug, developed by Dutch company Polpharma Biologics. 26 September 2023
Biosimilars
The date for the generics and biosimilars specialist Sandoz to spin out from its parent company Novartis has been announced. 25 September 2023
Biosimilars
Chicago, USA-based Meitheal Pharmaceuticals has announced an exclusive licensing agreement with Tonghua Dongbao Pharmaceutical to commercialize three insulin biosimilars in the USA. 22 September 2023
Biosimilars
Following a favorable recommendation form the European Medicines Agency’s advisory committee on July, the European Commission (EC) has now granted marketing authorization in the European Union (EU) for Indian drugmaker Biocon’s Yesafili, a biosimilar of Eylea (aflibercept). 21 September 2023
Biosimilars
The European Commission (EC) has granted marketing authorization for Fresenius Kabi’s biosimilar of Actemra/RoActemra (tocilizumab). 20 September 2023
Biosimilars
A feature on recent market activity in the biosimilar sector. 18 September 2023
Biosimilars
While the US medicines regulator has been granting approvals for biosimilar version of branded medicine for some time, it is only in the last year or so that they have been coming onto the market due to originators’ strong patent positions. 18 September 2023
Biosimilars
The Indian government has floated a scheme for the promotion of research and innovation in the pharmaceutical and medical technology sector, with an aim to reduce the country’s dependence on imports of products such as orphan drugs. 15 September 2023
Biosimilars
South Korea's Celltrion Healthcare has launched a campaign to celebrate a decade of continuous biosimilar innovation in Europe. 11 September 2023
Biosimilars
Samsung Bioepis has entered into a commercialization agreement with Sandoz for SB17, a proposed biosimilar to Johnson & Johnson subsidiary Janssen’s Stelara (ustekinumab). 11 September 2023
Biosimilars
There is a transformative shift taking place in the Crohn's disease (CD) treatment market, challenging AbbVie's mega blockbuster biological Humira's (adalimumab) long-standing dominance. 8 September 2023
Biosimilars
Industry analyst GlobalData has released research suggesting that a new Humira (adalimumab) biosimilar can expect to reach over $800 million in sales by the end of the decade. 1 September 2023
Biosimilars
Switzerland-based Sandoz has announced that the US Food and Drug Administration (FDA) has approved its biosimilar Tyruko (natalizumab-sztn), developed by Polpharma Biologics. 25 August 2023
Biosimilars
US pharmacy benefit manager (PBM) CVS Health today revealed it has set up a wholly-owned subsidiary, named Cordavis. 24 August 2023
Biosimilars
An Expert View from Róbert Wessman, founder and chairman of Icelandic biosimilars company Alvotech and investment fund Aztiq. 23 August 2023
Biosimilars
Swiss pharma giant Novartis (NOVN: VX) has scheduled a meeting for September 15, 2023, to gain shareholder approval for the proposed 100% spin-off of Sandoz, its generics and biosimilars. 21 August 2023
Biosimilars
Sandoz, the soon to be spun out biosimilars and generic business of Novartis, today released positive results from the MYLIGHT Phase III confirmatory efficacy and safety study for its biosimilar aflibercept, for patients living with wet macular degeneration – a key development in its efforts to address this area of unmet medical need. 15 August 2023
Biosimilars
German companies Fresenius Kabi and Formycon have reached a settlement with US healthcare giant Johnson & Johnson for the USA, concerning FYB202, a proposed biosimilar to Stelara (ustekinumab). 8 August 2023
Biosimilars
South Korea’s Samsung Bioepis and USA-based Organon have announced the interchangeable result of its Humira (adalimumab) biosimilar, SB5, based on a recently conducted Phase IV study. 3 August 2023
Biosimilars
The end of exclusivity for AbbVie’s top-selling biologic Humira (adalimumab) has provided a key test of whether biosimilars are finally ready to deliver on their promise in the US biopharmaceutical market. 2 August 2023
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