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Bioéticos Claims Launch of First Pembrolizumab Biosimilar in Paraguay

Aug 14, 2025

Paraguay-headquartered Bioéticos, which is part of Laboratorio Productos Eticos C.E.I.S.A (a member of Savone Holding and part of Insud Pharma) claims to have launched the first pembrolizumab biosimilar in Paraguay, under the name Pembrolizumab Bioéticos.  According to a banner currently appearing on Bioéticos’ website, and a May 2025 LinkedIn post, the biosimilar to MSD’s Keytruda® was developed by mAbxience.

However, in an article dated 14 August 2025, Generics and Biosimilars Initiative noted that as of mid-May 2025, there was no indication that Paraguay’s regulatory authority, DINAVISA (Dirección Nacional de Vigilancia Sanitaria), had officially approved a pembrolizumab biosimilar for use in Paraguay.

There have been no announcements by mAbxience in relation to the product.  Based on the clinicaltrials.gov database, mAbxience is undertaking a Ph 3 study to compare the PK, efficacy, safety and immunogenicity of MB12 (biosimilar pembrolizumab) versus Keytruda® in combination with pemetrexed-platinum chemotherapy as first-line treatment in patients with metastatic nsNSCLC.  The study commenced in December 2024 and is currently recruiting, with estimated primary completion in June 2026.