Two major strategic collaborations announced in July and August 2026 underscore the intensifying race to capture value from ...
On 2 June 2026, the US Food and Drug Administration (FDA) has approved Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar referencing Roche/Genentech’s Lucentis (ranibizumab). Ranluspec is ...
India's largest pharmaceutical acquisition strengthens Sun Pharma's global reach and positions the company among the world's leading biosimilars players. Sun Pharmaceutical Industries is advancing ...
In December 2025, the Organisation for Economic Co-operation and Development (OECD) published a working paper titled ‘Assessing the impact of promotion and advertising regulations on biosimilar uptake ...
On 31 December 2025, China’s State Council announced a revision of Regulation for the Implementation of the Drug Administration Law, which is expected to encourage research and innovation in the ...
On 1 October 2025, the European Medicines Agency (EMA) announced a significant enhancement to the existing Mutual Recognition Agreement (MRA) with the US Food and Drug Administration (FDA). As a ...
On 13 November 2025, the US Food and Drug Administration (FDA) approved Shanghai Henlius Biologics’ Poherdy (pertuzumab-dpzb) as an interchangeable biosimilar to Genentech’s Perjeta. Additionally, on ...
On 18 September 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending the granting of a marketing authorization for ...
In August and September 2025, the US Food and Drug Administration (FDA) approved six denosumab biosimilars, expanding treatment options for patients with bone health issues. The originator products ...
US pharmaceutical companies are increasingly licensing high-quality drug assets from China to replenish pipelines amid a looming patent cliff. This strategic shift, involving billions in deal value, ...
The biosimilar market is expanding rapidly, with key partnerships announced in mid-2025. Alvotech–Dr Reddy’s, Samsung Bioepis–NIPRO, and Formycon’s collaborations with Bio Usawa and Valorum Biologics ...
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