Biosimilars: A Comparative Study of Regulatory, Safety and Pharmacovigilance Monograph in the Developed and Developing Economies

Abstract

Epitomizing one of the rapidly maturing segments of pharmaceutical industry, biologics gestalt has severely implicated treatment algorithms of many life-threatening diseases especially in oncology, immunology, diabetes, and irresistible infections through integration of biologics in the clinical practice guidelines. As of 2021, the impact is expected to gain resilience as more patents on new biological drugs (such as Erbitux, Avastin, Orencis) are going off. Growing acceptance, trusting on stringent risk-benefits assessment, cost-effectiveness, and potential for return on investment, drive the global market of biosimilars is expected to remain steadfast in the following years; hence knowing about regulatory requirements for approval, opportunities, and barriers to biosimilars uptake in the biggest markets of USA, European Union, Canada, and Asia-Pacific (India and Pakistan) is warranted for development of effective biosimilars marketing strategies. This article reviews the biosimilars development from the beginning (historic) to the end (development & marketing approval perspectives) and then tries to present a clear picture on areas that are still uncertain concerning the biosimilars landscape especially the biologics effect on immunogenicity, the provocative issue of interchangeability, and extrapolation of indications.

On the Manufacturers of Biosimilars in Asia

“…Clinical pharmacology studies assess similarities of PK and PD (both efficacy and safety end points) between the proposed biosimilar product and the reference product 6 . The types of clinical pharmacology studies depend on the residual uncertainties in biosimilarity.…”

“…Clinical pharmacology studies assess similarities of PK and PD (both efficacy and safety end points) between the proposed biosimilar product and the reference product. 6 The types of clinical pharmacology studies depend on the residual uncertainties in biosimilarity. Phase I clinical studies are designed to study PK end points, such as area under the curve from time of dosing to the time of last quantifiable concentration (AUC 0-last ), AUC from time of dosing to infinity (AUC 0-inf ), maximum observed concentration of the drug (C max ), time it takes to reach the maximum concentration (T max or C max , elimination rate constant of drug (K el ), time required for half of the drug to be eliminated (t 1/2 ), apparent volume of distribution during terminal phase (V z/F ), and apparent oral clearance (C L/F ).…”

Temporal Effects of Galactose and Manganese Supplementation on Monoclonal Antibody N-Linked Glycosylation in Fed-Batch and Perfusion Bioreactor Operation

“…In addition to the approval of new innovators entering the market every year, there has been a rise within the biosimilar market as patent protections expire for older mAb products. 1,2 The ability of CHO cells to produce humanized or human-like posttranslational modifications, such as N-linked glycosylation, makes them highly desirable as an expression system for producing mAb products.…”