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16 March 2026 The escalating conflict in the Middle East has moved beyond oil markets and energy security to strike at one of India’s most globally integrated industries: pharmaceuticals.
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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
Biosimilars
Russian drugmaker Binnopharm Group together with China’s Mabwell announced plans to localize the production of a monoclonal antibody (MAb)-based drug for the treatment of asthma and atopic dermatitis in Russia. 4 February 2026
Biosimilars
The Delhi High Court in India has upheld the grant of a pharmaceutical patent to privately-held Swiss drugmaker Helsinn Healthcare for its nausea medication, an orally administered dosage form combining palonosetron (a 5-HT3 receptor antagonist) and netupitant (an NK1 receptor antagonist). 2 February 2026
Biosimilars
South Korea’s Samsung Bioepis says it has signed a settlement and license agreement with Regeneron and Bayer concerning the commercialization of SB15, a biosimilar to Eylea 2mg (aflibercept 40mg/mL solution), in countries excluding the USA and Canada. 30 January 2026
Biosimilars
South Korea’s Samsung Bioepis today released its first quarter 2026 biosimilar market report, marking the twelfth edition of the Quarterly Biosimilar Market Report in the United States (US) today. 23 January 2026
Biosimilars
India’s Zydus Lifesciences, an innovation-led life-sciences company with an international presence, has launched the world’s first biosimilar of nivolumab in India under the brand name Tishtha, reinforcing the company’s growing capability in advanced biologics and immuno-oncology. 22 January 2026
Biosimilars
UK headquartered Hikma Pharmaceuticals, along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc, have announced the launch of Enoby (denosumab-qbde) and Xtrenbo (denosumab-qbde), biosimilar products referencing US biotech major Amgen’s Prolia and Xgeva respectively. 20 January 2026
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Biosimilars
Celltrion’s US subsidiary has signed an agreement with pharmacy benefit managers (PBMs) Cigna Healthcare, and Express Scripts that will help expand patient access to Zymfentra (infliximab-dyyb). 29 August 2024
Biosimilars
Drug development consultancy Certara has published a report on the Inflation Reduction Act’s (IRA) impact on oncology biosimilar uptake. 29 August 2024
Biosimilars
South Korea’s Celltrion yesterday announced the European Commission (EC) approval for the use of SteQeyma (CT-P43), an ustekinumab biosimilar referencing Stelara, for the treatment of multiple chronic inflammatory diseases. 27 August 2024
Biosimilars
The USA’s Federal Trade Commission (FTC) said yesterday that it has submitted a comment supporting the Food and Drug Administration’s (FDA) draft guidance regarding interchangeable biosimilar drugs. 23 August 2024
Biosimilars
The US subsidiary of South Korea’s Celltrion announced its US Food and Drug Administration (FDA)-approved biosimilar adalimumab-aaty has been added to the Costco member prescription program. 14 August 2024
Biosimilars
The US Food and Drug Administration (FDA) has approved Enzeevu (aflibercept-abzv) 2mg vial kit and pre-filled syringe for intravitreal injection, developed by Swiss biosimilars company Sandoz. 12 August 2024
Biosimilars
The Biosimilars Council—part of the USA’s Association for Accessible Medicine (AAM) representing companies developing off-patent medicines—has provided an update on its activities on the regulatory, legislative and educational fronts. 5 August 2024
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
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