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15 June 2026 The European Federation of Pharmaceutical Industries and Associations (EFPIA) has urged EU lawmakers to widen a proposed patent-style incentive in the Biotech Act, warning that the current plan is too narrow to materially shift investment decisions.
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Biosimilars
Israel-headquartered Teva Pharmaceutical Industries has announced the launch of Ahzantive (aflibercept), a biosimilar to Eylea, in Europe further strengthening the company’s growing biosimilars portfolio and expanding its presence in ophthalmology. 4 June 2026
Biosimilars
South Korean biosimilar specialist Samsung Bioepis announced the launch of Opuviz 40mg/mL solution for injection in a vial, a biosimilar referencing eye diseases drug Eylea (aflibercept), across Europe, starting today. 29 May 2026
Biosimilars
In recent years, some stakeholders have held the view that Belgium is a difficult or even unattractive country for biosimilars, according to a website posting by trade group pharma.be. 26 May 2026
Biosimilars
Olayan Financing Company (OFC) has made a minority equity investment in Jordan-headquartered MS Pharma, a leading pharma player in the Middle East North Africa (MENA) region that specializes in the development, production and distribution of a broad portfolio of generic and biologic therapies. 20 May 2026
Biosimilars
The US Food and Drug Administration (FDA) on Friday approved Immgolis (golimumab-sldi) as an interchangeable biosimilar biological product to Simponi (golimumab) and Immgolis-ntri golimumab-sldi) to treat rheumatoid arthritis and ulcerative colitis. 16 May 2026
Biosimilars
Swiss drugmaker Sandoz today confirmed that the European Commission has granted marketing authorization for Bysumlog (insulin lispro) and Dazparda (insulin aspart). The two biosimilar insulins, for injection in prefilled pens, are developed by Gan & Lee Pharmaceuticals. 15 May 2026
Biosimilars
Industry group Medicines for Europe has urged policymakers to strengthen support for biosimilar medicines, arguing that wider uptake could improve patient access to biologic therapies while reinforcing Europe’s pharmaceutical resilience. 7 May 2026
Biosimilars
US generic drugmaker Lannett said the US regulator has approved Langlara (insulin glargine-aldy), an interchangeable biosimilar to Sanofi’s long-established diabetes treatment Lantus (insulin glargine). 6 May 2026
Biosimilars
Swiss generics and biosimilars firm Sandoz is entering what it calls a “golden decade” for biosimilars from a position of financial strength and renewed independence, according to Rebecca Guntern, chief commercial officer. 24 April 2026
Biosimilars
US drugmaker Amneal Pharmaceuticals, a diversified, global biopharmaceutical leader focused on expanding access to affordable and innovative medicines, has entered into a definitive agreement to acquire 100% of Kashiv BioSciences. 23 April 2026
Biosimilars
Israeli drugmaker Teva has regained the upper hand in its long-running migraine patent dispute with US pharma major Eli Lilly, after a federal appeals court reinstated a $176.5 million jury award tied to rival drugs Ajovy (fremanezumab) and Emgality (galcanezumab). 20 April 2026
Biosimilars
Japanese drugmaker Mochida Pharmaceutical announces that it has entered into an agreement with Qilu Pharmaceutical regarding the development and commercialization in Japan of Qilu’s biosimilar of follitropin alfa (genetical recombination). 16 April 2026
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
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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
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
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