Manufacturing of Biosimilars and Their Uses

Abstract

One of the pharmaceutical industry's fastest-growing segments, "biologics," has developed several innovative medicines for serious and uncommon diseases. In the 1980s, the first generation of recombinantly produced biopharmaceutical products was introduced, and its patent protection is about to expire. As a result, both research-based and generic pharmaceutical firms are vying for the chance to create biosimilars, or "generic" replacements for original biologics. In contrast to the relatively simple procedure of releasing a generic alternative to an innovator product based on a novel chemical entity, the introduction of a biosimilar to an innovator product is far more difficult. Since complete organisms or cultured cells manufacture biologics, these processes are intrinsically more unpredictable than chemical synthesis techniques. Because of this, it is hard to produce a similar or exact clone of an innovative product, unlike generic drugs. By being similar yet distinct, or " not the clone, but the twin," of the original biologic innovator product, biosimilars are described in this way. Therefore, the field of biosimilars presents a number of significant challenges, including i) the verification of similarity, ii) the interchangeability of biosimilars and innovator products, iii) the potential need for unique product names to distinguish the various biopharmaceutical products, iv) the regulatory framework, v) commercial opportunities as well as guidelines to assist manufacturers in product development, vi) intellectual property rights, and vii) public safety.