Therapeutic proteins are next-generation drugs in the prevention and treatment of diseases, in particular human critical illness like autoimmune diseases or cancer. The expiration of patents in the originally approved biopharmaceuticals has stimulated a great excitement and the subsequent development of these first-in-line biotherapeutic mAbs, known as mAb Biosimilars. These biologic medicines are a new class of drugs intended to offer comparable safety and efficacy (or clinical equivalence) to their original reference products which are brand name drugs and no longer under patent coverage. However, preparing similar copies of biologicals is much more challenging than replicating small molecules due to their structural complexity, intricate manufacturing processes and their potential risks for increased immunogenicity. Therefore, specific regulatory approval pathways and guidelines must be followed when creating Biosimilars. Biosimilars require more rigorous assessments than traditional chemical generics. This is because of the molecular complexity of recombinant proteins, and the complexity of biological manufacturing processes. Small differences can arise in a recombinant protein product which are hard to detect with state-of-the-art analytical techniques. Yet, these differences can have significant impact on the safety and efficacy of the drug. Thus, the European Medicines Agency (EMEA) has taken the lead in issuing guidelines that use the totality of data with orthogonal methodologies to assess the comparability of two biologic medicines in all their scientifically proven characteristics and mechanisms of action. This talk will describe the task to evaluate the drug in the context of the disease but not the opposite. With this concept it is possible to concentrate on assessing similarity of two mAbs but not their benefit to the patient, which was evaluated before by the original biologic. The guidelines advocate pre-clinical and clinical testing of biosimilars prior to market authorization, complemented by tailored pharmacovigilance plans. These guidelines provide a valuable base from which to develop in this evolving regulatory environment.
Disclosure of Interest None declared
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