Formycon and Bio Usawa to Launch FYB201 in Africa

Formycon has announced a new strategic partnership involving Bioeq AG, the licensee and exclusive global commercialization rights holder for Formycon’s biosimilar FYB201, and the African biotechnology company Bio Usawa Biotechnology. This agreement grants Bio Usawa exclusive rights to register and commercialize FYB201 under the brand name BioUcenta across Sub-Saharan Africa.

Expanding Access to Ranibizumab Biosimilar in Africa

BioUcenta, a biosimilar to Lucentis (ranibizumab), is a monoclonal antibody therapy indicated for the treatment of diabetic macular edema (DME), wet age-related macular degeneration (AMD), and diabetic retinopathy. These conditions are becoming increasingly significant public health challenges throughout Africa.

Formycon noted that while ranibizumab has been widely used in wealthier regions for nearly two decades, patients in Sub-Saharan Africa have faced limited access due to high costs and constrained distribution networks. This partnership is intended to close that gap by delivering a high-quality, affordable biosimilar alternative to millions across the region.

Partnership Aims to Improve Access to Vision-Saving Treatments

In a company news release, Dr. Menghis Bairu, Co-founder, President, and CEO of Bio Usawa, emphasized the broader significance of this agreement. He stated, “By making ranibizumab accessible in Sub-Saharan Africa, we are empowering doctors to save the vision of millions, particularly those suffering complications from diabetes—a disease that is quietly but rapidly becoming one of Africa’s greatest health threats. This collaboration is about equity. Access to advanced biologic therapies should not be a privilege of geography or income.”

Rising Diabetes and Diabetic Retinopathy Rates Underscore Urgency

According to the International Diabetes Federation, more than 24 million Africans were living with diabetes in 2024, a figure expected to double by 2050. Diabetic retinopathy, one of the most serious complications, may affect up to one-third of these patients, often resulting in irreversible vision loss without timely intervention.

Regulatory Preparations and Market Rollout

FYB201 was developed by Bioeq AG, a joint venture between Formycon AG and Polpharma Biologics Group BV and is already approved and available in 21 countries. With regulatory preparations underway, Bio Usawa plans to commence distribution of BioUcenta in key African markets starting in 2026.

Financial details of the agreement were not disclosed.