Current regulatory and scientific considerations for approving biosimilars in Iran.

With the expiration of patents on the first generation of rDNA biopharmaceuticals, competitors began to introduce biosimilar products. The concept of generics as applied to classical chemical drugs cannot be used for biotechnology products. Physicochemical characterization, bioassays and animal studies do not have the ability to predict reliably the safety and efficacy of biotherapeutics. Clinical studies are always necessary. While regulators all over the world were really in need of a comprehensive guideline in this area, WHO introduced a guideline which is principally a basis for regulating biosimilars and is applicable in Iran, as well as many other countries.