Guidelines on evaluation of similar bio-therapeutics

The Ethiopian Food, Medicine and Healthcare Administration and Control Authority is mandated by the proclamation No . 661/2009 to ensure the safety, quality and efficacy of medicines. Biotherapeutics are pharmaceutical products that fall in this jurisdiction that must be available in the market of Ethiopia of required safety, quality and effectiveness. Biotherapeutics are products of biological origin that exhibit some intrinsic variability. They are characterized by complex manufacturing processes. The quality of biotherapeutics cannot be assessed solely by testing the final product alone. Hence, Specific regulatory systems for these products should also be strengthened. Biotherapeutic products (biotherapeutics) have a successful record in treating many lifethreatening and chronic diseases. However, their cost has often been high, thereby limiting their accessibility to patients, particularly in developing countries. Recently, the expiry of patents and/or data protection for the first major group of originator’s biotherapeutics has ushered in an era of products that are designed to be “similar” to a licensed originator product. These products rely for their licensing partly on prior information regarding safety and efficacy obtained with the originator products. The clinical experience and established safety profile of the originator products should contribute to the development of similar biotherapeutic products (SBPs). A variety of terms, such as “biosimilar products”, “follow-on protein products” and “subsequententry biologics” have been coined to describe these products. The term “generic” medicine is used to describe chemical, small molecule medicinal products that are structurally and therapeutically equivalent to an originator product whose patent and/or data protection period has expired. Demonstration of bioequivalence of the generic medicine to a reference product is usually appropriate and sufficient proof of therapeutic equivalence between the two. However, the approach established for generic medicines is not suitable for the development, evaluation and licensing of SBPs since biotherapeutics consist of relatively large and complex proteins that are difficult to characterize. The clinical performance of biotherapeutics can also be much influenced by the manufacturing process and some clinical studies will also be required to support the safety and efficacy of a SBP.