Biosimilars News
Biosimilars
Industry groups are urging changes to the US Food and Drug Administration’s Biosimilar User Fee Amendments programme as talks begin on reauthorizing the scheme for another five years. BsUFA, which funds FDA’s biosimilar reviews through user fees, expires in September 2027 and will require new legislation to continue. 7 January 2026
Biosimilars
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
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
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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
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Biosimilars
20 January 2026 India’s Sun Pharma has addressed speculation regarding a potential $10 billion acquisition of US firm Organon.
Biosimilars
19 December 2025 South Korean biosimilars specialist Celltrion said the European medicines regulator has adopted a positive opinion for an autoinjector version of SteQeyma, its biosimilar to Stelara (ustekinumab).
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Biosimilars
For two decades, immunology was the golden child of biopharma. Blockbusters like Humira (adalimumab), Enbrel (etanercept) and Remicade (infliximab) dominated the sales charts and funded pipelines across the industry. 26 September 2025
Biosimilars
Biosimilars, once met with skepticism, are now an undeniable force in the global pharmaceutical market. As several blockbuster biologics lose exclusivity, biosimilars are stepping in to capture market share and drive savings for healthcare systems worldwide. While adoption in the USA has lagged behind other regions, there are signs that this may be changing. Despite ongoing challenges, the US market is seeing increasing uptake, with biosimilars poised to reshape competition and access to life-saving treatments. 4 August 2025
Biosimilars
After nearly 27 years as a division of Swiss giant Novartis, generics and biosimilars specialist Sandoz went its own way in October 2023. 2 August 2025
Biosimilars
US tariffs have served as a significant catalyst for Indian pharmaceutical companies to reassess their strategies, leading to accelerated efforts in market and product diversification. The challenging environment has encouraged a strategic shift towards higher margin products, reports The Pharma Letter’s India correspondent. 31 July 2025
Biosimilars
An Expert View from Dr Elena Wolff-Holz, global head of clinical development at Biocon Biologics, the biosimilar subsidiary of Biocon. 7 April 2025
Biosimilars
US crackdown on Chinese biotech opens opportunities for Indian companies 18 June 2024
Biosimilars
Indian pharma majors rally for strong US-India trade alliance 20 May 2024
Boardroom
Samsung Bioepis has appointed Kyung-Ah Kim as its new president and chief executive, succeeding Christopher Hansung Ko, who will lead the Samsung Future Business Division. 27 November 2024
Biosimilar-focused biopharmaceutical company and contract development and manufacturing organization (CDMO) Tanvex BioPharma has named Stephen Lam its new chief executive (CEO). 5 September 2024
Swiss pharma giant Novartis’s board of directors announced today the appointment of Gilbert Ghostine as chairman-designate of the new board of Sandoz, its biosimilars and generics business. 20 February 2023
The American business of South Korea's Celltrion Healthcare has appointed Thomas Nusbickel as chief commercial officer. 7 February 2023
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