According to Bioéticos, Paraguay has made significant progress in improving access to cancer treatments with the launch of the first pembrolizumab follow-on biological. The originator product is Merck Sharp & Dohme’s Keytruda (pembrolizumab).

Pembrolizumab is a humanized (from mouse) monoclonal antibody that binds to, and blocks PD-1 located on lymphocytes. It is an anticancer medication used in the treatment of melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, urothelial cancer (cancer of the bladder and urinary tract), and renal cell carcinoma (kidney cancer) [1].

In May 2025, Bioéticos announced the launch of the first pembrolizumab follow-on biological in Paraguay under the brand Pembrolizumab Bioéticos, developed by mAbxience. This advancement marks a major improvement in access to highly complex immunotherapies, offering patients a safe, effective, and more affordable alternative for treating various cancers.

However, as of mid-May 2025, there is no indication that DINAVISA (Dirección Nacional de Vigilancia Sanitaria; National Directorate for Sanitary Surveillance), Paraguay’s medicines regulatory authority, has officially approved a pembrolizumab biosimilar – branded as Pembrolizumab Bioéticos – for use in Paraguay.

Records show that Paraguay’s medicines regulator has approved only two follow-on biologicals to date:

1. Bevacizumab Bioéticos – for indications including breast and colorectal cancer
2. Rituximab Bioéticos – targeting diseases such as rheumatoid arthritis, leukaemia, and non-Hodgkin lymphoma.

Both were approved in October 2021 [2].

mAbxience, which was acquired by Fresenius Kabi in mid-2022 [3], has engaged in multiple partnerships in Korea [4], and other emerging markets [5]. 

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pembrolizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Aug 14]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-pembrolizumab
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Paraguay [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Aug 14]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-paraguay
3. GaBI Online - Generics and Biosimilars Initiative. Fresenius Kabi acquire mAbxience and Ivenix [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Aug 14]. Available from: www.gabionline.net/pharma-news/fresenius-kabi-acquire-mabxience-and-ivenix
4. GaBI Online - Generics and Biosimilars Initiative. HK inno.N–mAbxience partnership in Korea and Coherus advances in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Aug 14]. Available from: www.gabionline.net/pharma-news/hk-inno.n-mabxience-partnership-in-korea-and-coherus-advances-in-the-us
5. GaBI Online - Generics and Biosimilars Initiative. Abbott and mAbxience partnership for biosimilars in emerging markets [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Aug 14]. Available from: www.gabionline.net/pharma-news/abbott-and-mabxience-partnership-for-biosimilars-in-emerging-markets

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