Noghayin Mega EHIGIE
University of Benin, Nigeria
Title: Comparative Testing And Pharmcovigilance Of Biosimilars
Biography
Biography: Noghayin Mega EHIGIE
Abstract
Unlike traditional generic pharmaceuticals, Biosimilars (also known as biopharmaceuticals in the United States) aim to copy a complex recombinant, three dimensional protein structure with high molecular weight small changes in the manufacturing process can alter the poducts effect and safety. According to the guild lines of the European agency for evaluation of medicinal products (EMEA) extensive comparability testing will require to demonstrate that the Biosimilars has a comparable profile in terms of quality, safety and efficacy as the reference products. Various analytical assays are available to compare physiochemicals and biological properties between production batches of a potentially similar biopharmaceuticals (comparability) and in comparison with a reference products (similarity).It is important to recognise the limits of existing assay so that the results can be accurately interpreted for market authorisations. This work examines the quality and limits of such analytical tests to demonstrate comparability and similarity of a Biosimilars products to a reference drug with respect to protein content, activity, physio chemical integrity. Stability, impurities and additives, as well as immunogenicity are discussed. Although several assay are available, reliable tests for safety and efficacy still require development. Furthermore, international standards are missing and materials and methods differ from laboratories making the comparison of results very difficult. Clinical trials and post authorisations pharmacovigilance are essential to quarantee the products safety and efficacy over time. Pharmacovigilance, as part of a comprehensive risk management programme, will need to include regular testing for consistent manufacturing of the drugs.