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The US Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). 1 December 2017

Swiss drugmaker Roche is suing Pfizer, the world’s biggest pharma company, over alleged infringements of patents relating to the cancer drug Herceptin (trastuzumab). 22 November 2017

India’s Biocon and Netherlands-incorporated Mylan have suffered a setback in their bid for US FDA approval for MYL-1401H, the firms’ jointly-developed Neulasta biosimilar. 10 October 2017

The trade group representing manufacturers of generic and biosimilar medicines in Europe has sounded a warning about the ‘unsustainably low’ prices being paid for off-patent drugs that are leading some drugmakers to withdraw from the market and causing shortages of certain products. 29 September 2017

Amgen and Chinese drugmaker Simcere Pharmaceutical Group have signed an exclusive agreement to co-develop and commercialize four biosimilars in China. The collaboration includes undisclosed biosimilars in the areas of inflammation and oncology. 28 September 2017

Hospira, a biosimilar injectables specialist now belonging to US pharma giant Pfizer, has been ordered to pay $70 million for infringing a patent belonging to Amgen relating to the anemia treatment Epogen (epoetin alfa). 25 September 2017

Pharma giant Pfizer has filed a US lawsuit against Johnson & Johnson, accusing the healthcare firm of using exclusionary contracts and other 'anticompetitive' practices to maintain its monopoly in connection with the arthritis drug Remicade (infliximab). 21 September 2017

The generics and biosimilars industry has released a document claiming that the US government could save over $10 billion in a decade if the Centers for Medicare & Medicaid Services were to adopt a different reimbursement model. 20 September 2017

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South Korea’s biosimilar drug developer Samsung Bioepis today released its Third Quarter 2025 Biosimilar Market Report, marking the tenth edition reviewing the situation in the USA. 21 July 2025

South Korea’s Samsung Bioepis today announced it has entered into a license, development and commercialization agreement (DCA) with Harrow, for Samsung Bioepis’ ophthalmology portfolio. 17 July 2025

Biosimilars

FDA approves Biocon BLA for Kirsty

The US Food and Drug Administration approved, the first rapid-acting interchangeable biosimilar product, Kirsty (insulin aspart-xjhz, as a 3 mL single-patient-use prefilled pen and 10 mL multiple-dose vial. Kirsty is biosimilar to and interchangeable with Novolog (insulin aspart), from Denmark’s Novo Nordisk. 16 July 2025

South Korea’s Samsung Bioepis today published a whitepaper titled ‘Solving the Biosimilar Void in Europe’ that proposes policy recommendations to fully recognize the value of biosimilars and ensure a more sustainable market in Europe. 14 July 2025

The US subsidiary of South Korea-based Celltrion today announced that Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo), biosimilars referencing US biotech major Amgen’s (Nasdaq: AMGN) denosumab brands Prolia and Xgeva, had been launched in the USA. 8 July 2025

Indian biosimilars company Biocon Biologics, a subsidiary of Biocon, today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorizations for Vevzuo and Evfraxy, biosimilars of Amgen’s (Nasdaq: AMGN) denosumab (trade names Xgeva and Prolia). 7 July 2025

Indian biosimilars developer Biocon Biologics, a subsidiary of Biocon Ltd has announced that the European Commission (EC) has granted marketing authorization in the European Union (EU) for Vevzuo and Evfraxy biosimilars of denosumab, originated by Amgen. 4 July 2025

Swiss biosimilars and generics major Sandoz has announced the start of construction for a new, state-of-the-art biosimilars production center for sterile product manufacturing in Brnik, Slovenia. 2 July 2025

German biosimilars company Formycon has announced that its 2025/2029 corporate bond was significantly oversubscribed due to high demand, leading to an increase in the initially targeted issuance volume from 50 million euros ($59 million) to 70 million euros. 28 June 2025

Indian drugmaker Biocon has announced that Health Canada has granted a Notice of Compliance for Yesafili (aflibercept), a biosimilar to Eylea (aflibercept) injection, in vial and prefilled syringe presentations, 2 mg/0.05 mL. 27 June 2025

Germany’s Formycon announced that Klinge Biopharma, the exclusive owner of the global commercialization rights of FYB203/Ahzantive (aflibercept-mrbb), Formycon’s biosimilar to Bayer’s Eylea, concluded an exclusive license agreement with US biosimilars specialist Valorum Biologics for the commercialization of the product in the USA and Canada. 25 June 2025

South Korea’s biosimilar drug developer Samsung Bioepis today presented the long-term safety data of Epysqli (eculizumab; SB12), a biosimilar to AstraZeneca’s Soliris, in paroxysmal nocturnal hemoglobinuria (PNH) at the European Hematology Association (EHA) Congress 2025 held at Milan, Italy from June 12 to 15. 12 June 2025

Specialty immunotherapy company Tevogen Bio Holdings has announced the execution of a lease agreement to expand its corporate headquarters in Warren, New Jersey, more than doubling its footprint. 10 June 2025

South Korea’s biosimilar drug developer Samsung Bioepis has announced that the company has entered into a license, development and commercialization agreement with Nipro Corporation for multiple biosimilar candidates including SB17, a ustekinumab biosimilar candidate, in Japan. 9 June 2025

Germany’s Formycon has announced that the Brazilian regulatory authority Anvisa has granted marketing authorization for FYB201/Ranivisio, a Lucentis (ranibizumab) biosimilar. 5 June 2025

Swiss generic and biosimilar medicines company Sandoz today announced that Wyost (denosumab) and Jubbonti (denosumab) are available to patients in the USA starting today. 2 June 2025

In a website posting, the International Generic and Biosimilar medicines Association (IGBA) has commended the General Assembly of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) for its adoption of a new topic focused on the harmonization of "Framework for Determining Utility of Comparative Efficacy Studies in Biosimilar Development Programs." 2 June 2025

Indian biosimilars developer Biocon Biologics, a subsidiary of Biocon Ltd , today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for its Yesintek, a biosimilar of ustekinumab, which is marketed under the trade name Stelara by us healthcare giant Johnson & Johnson (NYSE: JNJ) . 27 May 2025

South Korea has launched the Priority Infectious Disease Pandemic Preparedness Rapid R&D Support Program, led by the Korea Disease Control and Prevention Agency (KDCA) in collaboration with SK bioscience. 26 May 2025

The Food and Drug Administration (FDA) has granted an expanded interchangeable designation for Yuflyma (adalimumab-aaty), now including prefilled syringe (40mg) and autoinjectors (40mg and 80mg) presentations. 26 May 2025

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