25 July 2025 French diabetes and obesity specialist Adocia was trading 45% higher late Friday following its partner Tonghua Dongbao’s release of positive topline results from the Phase III trial of BioChaperone Lispro (THDB0206 injection), a novel ultra-rapid insulin formulation.
Merck & Co has announced the launch of Ontruzant, the first biosimilar version of Roche’s big-selling cancer drug Herceptin (trastuzumab), for patients in the UK. 7 March 2018
The European Medicines Agency has accepted the regulatory resubmission of a proposed biosimilar to Amgen’s (Nasdaq: AMGN) Neulasta (pegfilgrastim). 6 March 2018
Mylan and Revance Therapeutics today announced a global collaboration and license agreement for the development and commercialization of a proposed biosimilar to Botox (onabotulinumtoxinA). 1 March 2018
Following the approval of a Remicade (infliximab) biosimilar from Russian company Biocad in its home country last month, the company anticipates that this product will enter other markets at the end of 2018 or in early 2019. 20 February 2018
The European Commission (EC) has approved Herzuma (trastuzumab biosimilar) for the treatment of patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification. 14 February 2018
YL Biologics (YLB) has announced that a Phase III clinical trial of its investigational Enbrel (etanercept) biosimilar YLB113 has met its primary endpoint. 9 February 2018
Californian life sciences firm BioSciencesCorp has partnered with Shanghainese CMO Mab-Venture, to develop and manufacture multiple undisclosed biosimilars for emerging markets. 9 February 2018
Pfizer’s manufacturing partner in South Korea Celltrion has received a warning letter from the US FDA after an inspection of its Incheon-based facility uncovered “issues related to certain manufacturing processes.” 7 February 2018
While the likes of Amgen and Johnson & Johnson have already started to take the hit from competitors to big-selling biologics, looking ahead to the next two to three years, it is unlikely that the specter of biosimilars hangs over any company more than Roche. 5 February 2018
Korean biosimilar company Samsung Bioepis is making a habit of presenting data on its products that shows that they not only compare with the original, but could actually be superior to the reference drug. 29 January 2018
US pharma giant Pfizer could be yet another contender in the growing number of biosimilar copies of Roche’s blockbuster cancer drug Rituxan/MabThera (rituximab). 24 January 2018
A research note from Samsung Bioepis, accepted for publication in the British Journal of Dermatology, suggests the firm’s etanercept biosimilar may be less immunogenic than the reference product Enbrel, produced by Amgen. 23 January 2018
Positive results of the Phase III study for JR-131, a proposed biosimilar to darbepoetin alfa, a long-acting erythropoiesis-stimulating agent for the treatment of renal anemia, have been announced by Japanese drugmakers Kissei Pharmaceutical and JCR Pharmaceuticals. 19 January 2018
Sandoz, Swiss pharma giant Novartis’ generics and biosimilars business, has signed a global partnership with Indian drugmaker Biocon, to develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide. 18 January 2018
Sandoz, the biosimilars and generics division of Swiss pharma giant Novartis, says that the US Food and Drug Administration has accepted its Biologics License Application (BLA), submitted under the 351 (k) pathway, for proposed biosimilar adalimumab to the reference medicine, Humira. 16 January 2018
A New Year report from CPhI forecasts 2018 will be a transformative year for Japanese pharma as the market evolves towards growth in generics, biosimilars and increased internationalization. 15 January 2018
The first biosimilar version of Roche’s blockbuster Herceptin (trastuzumab) has been approved in Brazil by ANVISA, the country’s medicines regulatory agency. 29 December 2017
Jordanian drugmaker Hikma Pharmaceuticals now has exclusive rights to sell a biosimilar of Rituxan/MabThera (rituximab) in the Middle East and North Africa (MENA) after agreeing a deal with South Korean biopharmaceutical firm Celltrion. 19 December 2017
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
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