Biosimilars News
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
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
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
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Biosimilars
Shilpa Biologicals, part of India’s Shilpa Medicare, has entered into a co-development and supply agreement with Finnish drugmaker Orion Corporation for a nivolumab biosimilar. 16 July 2026
Biosimilars
US lawmakers have introduced bipartisan legislation that would reduce routine reliance on comparative clinical efficacy studies in biosimilar approvals, a move welcomed by the Association for Accessible Medicines (AAM) and its Biosimilars Council. 16 July 2026
Biosimilars
South Korea’s Samsung Bioepis and Organon, a global healthcare company with expertise in biosimilars, have announced the expansion of their development and commercialization agreement, for a new biosimilar in Australia by Organon ANZ. 16 July 2026
Biosimilars
Swiss generics and biosimilars company Sandoz has announced a set of senior leadership changes designed to sharpen its operations and dealmaking ahead of what it calls a "golden decade" of branded-drug patent expiries. 15 July 2026
Biosimilars
India-based OneSource Specialty Pharma, a specialty pharmaceutical contract manufacturer, and German biosimilar drugs developer Formycon have announced a strategic manufacturing partnership for biosimilars. 14 July 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
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
This month, Samsung Bioepis announced the European launch of Obodence (60 mg pre-filled syringe) and Xbryk (120 mg vial), denosumab biosimilars referencing Prolia and Xgeva. 29 December 2025
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
Boardroom
Swiss generics and biosimilars company Sandoz has announced a set of senior leadership changes designed to sharpen its operations and dealmaking ahead of what it calls a "golden decade" of branded-drug patent expiries. 15 July 2026
Swiss generics and biosimilars company today announced the creation of a new biosimilar development, manufacturing and supply unit. 10 March 2026
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
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