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Bioeq/Formycon/Bio Usawa Secure First Biosimilar Ranibizumab Approval in Africa

Oct 21, 2025

On 21 October 2025, African biotechnology company Bio Usawa announced that the Rwanda Food and Drugs Authority has granted market approval for its BioUcenta™, biosimilar to Genentech’s Lucentis® (ranibizumab), making the product the first ranibizumab biosimilar approved in Africa.

Bioeq AG, which holds the exclusive worldwide commercialisation rights for Formycon’s FYB201, entered into an exclusive partnership with Bio Usawa for the commercialisation of FYB201 under the brand name BioUcenta™ in Sub-Saharan Africa.

FYB201 was developed by Bioeq (a JV between Formycon and Polpharma Biologics), and has been approved in the UK (in May 2022, marketed as Ongavia® by Teva), in the US (in August 2022, marketed as Cimerli®, to which Sandoz acquired the marketing rights from Coherus in March 2024), the EU (in August 2022, marketed as Ranivisio® by Teva)Canada (in December 2023marketed as Ranopto™ by Teva) and MENA (in March 2024, marketed as Ravegza® by MS Pharma).