Regulatory considerations in biosimilars: Middle East and Africa regions

Biotherapeutic products whose patent protection has expired yield way to the development and approval of the more affordable follow on medicines, known as biosimilars. These products need to have been shown as comparable in terms of quality, safety, and efficacy to the reference product (RP). In countries of the Middle East and Africa (MEA), there is a tremendous rise in deaths related to non-communicable diseases (NCDs). This class of diseases contributes to more than 38 million deaths worldwide annually, and they account for 74% of all deaths in MEA regions. The African continent consists of 54 countries, with each country having its own regulatory authority. To date, of the 54 African states, South Africa is the only country that has established a clear regulatory framework for biosimilar approval. This article highlights the prospects of biosimilars in the MEA market. The regulatory framework in the various MEA countries has also been discussed.

Automated summary

Biological therapeutic products with expired patents are being replaced by more affordable biosimilars, which must demonstrate comparable quality, safety, and efficacy to the reference product. The Middle East and Africa are seeing a rise in deaths related to non-communicable diseases, with South Africa being the only country in Africa with a clear regulatory framework for biosimilar approval.