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Biotechnology
9 April 2026 Jeito Capital, a Paris, France -based independent private equity fund dedicated to Biopharma, has announced the final closing of its second fund Jeito II, exceeding its target at $1.2 billion (above 1 billion euros), and marking a new major milestone for European Biopharma investment.
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Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
South Korean Samsung Group’s biopharmaceutical business is being reorganized into two separate tracks: contract development and manufacturing organization (CDMO) and biosimilars. 22 May 2025
Biosimilars
Swiss biosimilars specialist Sandoz has launched what it says is the first autoinjector presentation of a biosimilar to Stelara (ustekinumab) in Europe, bolstering its presence in the region’s rapidly expanding immunology market. 22 May 2025
Biosimilars
Formycon and its commercialization partner Fresenius Kabi have announced that the US Food and Drug Administration (FDA) has designated FYB202/Otulfi (ustekinumab-aauz) as interchangeable with Johnson & Johnson’s (NYSE: JNJ) reference biologic Stelara (ustekinumab). 19 May 2025
Biosimilars
The US Food and Drug Administration’s (FDA biosimilar approvals reached a record 19 in 2024, with projections indicating that 2025 could surpass this milestone trend. 16 May 2025
Biosimilars
Teva Pharmaceutical Industries’ US subsidiary and Iceland-based Alvotech (Nasdaq: ALVO) today announced that the US Food and Drug Administration (FDA) has approved Selarsdi (ustekinumab-aekn) injection as interchangeable with the reference biologic Stelara (ustekinumab). 5 May 2025
Biosimilars
Swiss generics and biosimilars major Sandoz has signed a global collaboration with Shanghai Henlius Biotech to commercialize a biosimilar of leading oncology therapy, ipilimumab, the active ingredient of Bristol Myers Squibb’s blockbuster drug Yervoy. 30 April 2025
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Biosimilars
Israel-based Teva Pharmaceutical Industries today announced three milestones in its biosimilar portfolio, demonstrating continued momentum in the advancement of its Pivot to Growth strategy. 30 March 2026
Biosimilars
Indian biopharma Biocon has appointed Shreehas Tambe as chief executive and managing director, marking the first time a single executive will lead its combined biosimilars and generics business. 27 March 2026
Biosimilars
Japanese drugmaker Mochida Pharmaceutical has announced that it has obtained manufacturing and marketing approval for tocilizumab BS MA (development code: RGB-19) in Japan. 26 March 2026
Biosimilars
Singapore-based biotech Prestige Biopharma has reported positive Phase III results for its Avastin (bevacizumab) biosimilar HD204 in advanced non-squamous non-small cell lung cancer. 24 March 2026
Biosimilars
Germany’s Formycon and its license partner Klinge Biopharma announced a settlement and license agreement with Regeneron Pharmaceuticals and Bayer, resolving all patent disputes related to the EU-approved Eylea (aflibercept) 2mg biosimilars Ahzantive and Baiama. 19 March 2026
Biosimilars
South Korea’s Samsung Bioepis has entered into a global license, development and commercialization agreement (DCA) with Switzerland-based Sandoz for up to five biosimilar candidates under development by Samsung Bioepis, including SB36, a biosimilar candidate referencing Entyvio (vedolizumab). 18 March 2026
Biosimilars
Spanish biologics CDMO 3PBIOVIAN has signed an agreement with Colombia’s National Cancer Institute to develop a biosimilar monoclonal antibody for an oncology indication, in a program aimed at expanding access to cancer medicines in the country. 13 March 2026
Biosimilars
Costa Rica-based specialty healthcare company SteinCares has signed a licensing agreement with India’s Shilpa Biologicals, part of Shilpa Medicare, to commercialize a biosimilar across Latin America. 11 March 2026
Biosimilars
Russian drugmaker Biocad risks losing the market for its anti-cancer drug pertuzumab, where it expanded in 2025. This is due to recent submitting a lawsuit against the company by Swiss pharma giant Roche for patent infringement of branded Perjeta, reports The Pharma Letter’s local correspondent. 10 March 2026
Biosimilars
The US Food and Drug Administration (FDA) has released New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4). 10 March 2026
Biosimilars
Swiss generics and biosimilars company today announced the creation of a new biosimilar development, manufacturing and supply unit. 10 March 2026
Biosimilars
Iranian biopharma CinnaGen has secured European marketing authorization for Zandoriah (teriparatide), a biosimilar to Forsteo, the osteoporosis drug from US pharma major Eli Lilly. 2 March 2026
Biosimilars
Latin American specialty pharma company SteinCares has signed a licensing agreement with India’s Shilpa Biologicals to commercialize a biosimilar across Latin America, marking the Indian group’s first entry into the region. 25 February 2026
Biosimilars
Switzerland’s Sandoz has reported that the European Commission has granted marketing authorization for Ranluspec, a biosimilar ophthalmology drug referencing Lucentis (ranibizumab). 23 February 2026
Biosimilars
Switzerland-based generic and biosimilar drugs specialist Sandoz today announced that the US Food and Drug Administration (FDA) has approved an expanded label for Enzeevu (aflibercept-abzv), to include multiple retinal indications. 18 February 2026
Biosimilars
Japanese biosimilars and cell therapies company Kidswell Bio and Treehill Partners, a healthcare asset and corporate development advisor, today announced the creation of a new US based regenerative medicine company, Kidswell USA. 16 February 2026
Biosimilars
German generics and consumer healthcare major STADA Arzneimittel and China’s Bio-Thera Solutions have received a marketing authorization from the European Commission for their Gotenfia (golimumab) biosimilar referencing Simponi, from Johnson & Johnson. 13 February 2026
Biosimilars
South Korea’s Samsung Bioepis has signed a settlement and license agreement with US biotech Regeneron concerning the commercialization of Opuviz (aflibercept-yszy), a biosimilar to Eylea 2mg (aflibercept), in the USA, following an earlier settlement covering Europe and the Rest of the World (RoW). 12 February 2026
Biosimilars
Germany’s Formycon and Taiwan generics drugmaker Lotus Pharmaceuticals today announced the conclusion of an exclusive license agreement for Formycon’s Keytruda biosimilar candidate FYB206 (pembrolizumab). 11 February 2026
Biosimilars
Chinese biotech Bio-Thera Solutions has signed commercialization and license agreements with Saudi drugmaker Avalon Pharma for BAT3306, a proposed biosimilar to Keytruda (pembrolizumab), covering Saudi Arabia and the wider Middle East and North Africa region. 9 February 2026
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