Comparability and biosimilarity: considerations for the healthcare provider

Abstract

Given the knowledge gap under which biosimilars are developed, data to establish biosimilarity should go beyond a simple comparability exercise.

Steps to ensure adequate supply of biological medicines: considerations for the healthcare provider

“…An example is in infl ammatory conditions such as rheumatoid arthritis where a number of biological modulators of the tumour necrosis factor pathway have been approved to treat this condition [33]. Additionally, with expiration of patents and exclusivity rights for some biologicals, biosimilars, are entering regulatory evaluation, approval, and marketing in different regions [34]. This presents HCPs with a choice between the approved innovator biological and one or more of the approved biosimilars.…”

Challenges and Future Consideration for Pharmacovigilance

“…Thus, it is very unlikely that manufacturer of the biosimilar will be able to precisely replicate the reference protein product as the original method is proprietary information of the owner of the reference product. It is recognized that small changes in the production and purification process of biologicals alter their safety profile as an adverse event can be related to a specific biological product [18,19]. Thus, regardless of the fact that the biosimilar and reference drug can show similar efficacy, the biosimilar can show different safety profile, which may influence the benefit-risk profile.…”

Comprehensive Review on Manufacturing Process and Characterization of Biosimilar Drugs

“…Scientific advancements in recombinant genetic engineering techniques and refinements in manufacturing processes has made its path to success at a very great pace in the field where biological proteins are used in disease treatment (Cai et al, 2011;Tsiftsoglou et al, 2013;Lee et al, 2012;Nowatzke et al, 2011). Biological medicines play pivotal role in treatment for harmful and fatal diseases, such as cancer, hepatitis, autoimmune disorders, neurodegenerative diseases, and orphan diseases.…”