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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
Chinese biotech Bio-Thera Solutions (SHSE: 688177) has picked up European Medicines Agency approval for BAT1706, a biosimilar referencing Avastin (bevacizumab). 1 August 2024
Biosimilars
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has adopted positive opinions for six biosimilar medicines. 27 July 2024
Biosimilars
Swiss generics and biosimilars major Sandoz announced the launch of Pyzchiva (ustekinumab) across Europe, starting today. 25 July 2024
Biosimilars
The US Food and Drug Administration (FDA) has issued a Federal Register notice, “Biosimilar Product Development Guidance; Establishment of a Public Docket; Request for Information and Comments.” 25 July 2024
Biosimilars
Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products. 23 July 2024
Biosimilars
The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) submitted by South Korea’s Samsung Bioepis for Epysqli (eculizumab-aagh) as a biosimilar to Soliris (eculizumab). 22 July 2024
Biosimilars
Gedeon Richter today announced that the European Medicines Agency (EMA) has accepted the company’s two marketing authorization applications (MAAs) for its proposed biosimilar to denosumab. 19 July 2024
Biosimilars
Privately-held German drugmaker Boehringer Ingelheim has inked a deal with GoodRx (Nasdaq: GDRX), in a bid to boost US penetration of its biosimilar to Humira (adalimumab). 18 July 2024
Biosimilars
The mandate to conduct routine comparative clinical efficacy studies for biosimilar medicines, compounded by duplicative regional requirements, serves as a barrier to greater medicine access for patients, said the trade group International Generic and Biosimilar Medicines Association (IGBA). 13 July 2024
Biosimilars
South Korea’s Samsung Bioepis has released its Third Quarter 2024 Biosimilar Market Report, which includes the latest Average Sales Price (ASP) information of all biosimilars and reference products available in the US market. 12 July 2024
Biosimilars
India's Zydus Lifesciences has been barred by the Delhi High Court from selling its breast cancer drug, Sigrima, a biosimilar version of Roche's pertuzumab (brand name Perjeta). 12 July 2024
Biosimilars
The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Pyzchiva (ustekinumab-ttwe) submitted by South Korean firm Samsung Bioepis. 1 July 2024
Biosimilars
In the USA, the Food and Drug Administration has announced the availability of a draft guidance for industry which could smooth the path for biosimilars developers to gain interchangeable status for their products. 21 June 2024
Biosimilars
The recent US crackdown on Chinese biotech companies marks a significant shift in the global biotechnology landscape, with profound implications for competitive strategies. 18 June 2024
Biosimilars
Celltrion has announced positive Phase III data for CT-P47, a biosimilar referencing Actemra (tocilizumab). 14 June 2024
Biosimilars
South Korea’s Samsung Bioepis today presented the post-hoc analysis of the Phase III clinical study results for Epysqli (SB12), a biosimilar to AstraZeneca’s Soliris (eculizumab), at the EHA Congress. 14 June 2024
Biosimilars
Icelandic company Alvotech and Germany’s STADA Arzneimittel are strengthening their existing strategic alliance for biosimilars by extending their partnership to cover AVT03. 13 June 2024
Biosimilars
As the BIOSECURE Act progresses through the US legislative process, the US pharmaceutical industry finds itself at a crossroads. 10 June 2024
Biosimilars
Italy's Competition Authority (AGCM) is investigating four pharmaceutical companies over what it called coordination of their commercial strategies, allegedly delaying access to a biosimilar eye-disease treatment in the country. 6 June 2024
Biosimilars
As more biologics drugs lose their patent protection, the influx of biosimilars is set to expand, offering cost-effective alternatives and significantly impacting their respective markets. 5 June 2024
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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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