Biologics and Biosimilars: Differences and Clinical Implications
Journal Title: Journal of Advances in Medicine and Medical Research - Year 2016, Vol 12, Issue 7
Abstract
Biologics or biopharmaceuticals are drugs derived from living organisms by recombinant technology. Biologics have made a significant contribution to the management of certain chronic diseases such as cancer, rheumatoid, arthritis, ankylosing spondylitis, psoriasis and other immune mediated disorders. Biologics are produced by genetically modifying cells and, are highly complex and expensive to manufacture. Many of them are now facing patent expiry which has paved the way for the development of biosimilars. Biosimilars are biologic medicine that is similar in terms of quality, safety and efficacy but not the same as a registered innovator biologic. The manufacturing of biosimilars has many complexities, such as consistency of manufacturing process, conformation of manufacturing standards and demonstration of product consistency Also, powered clinical trials have to be executed to demonstrate similarity to the innovator biologic. Registration of biosimilars requires a more stringent evaluation than that is required for conventional generics. Biosimilars have the potential to be the molecules of the future as long as they are developed strictly in accordance with comparative procedures mandated by regulatory authorities such as EMA and USFDA. It is believed that the advent of biosimilars will improve patient access to expensive biologics for chronic illnesses. However, it is important that clinicians distinguish between innovator biologics and biosimilars. Physicians should avoid substituting biosimilars for innovators as well as avoid interchangeability as biosimilars are not generics. In addition, pharmacovigilance will be the need of the hour to track down any safety and efficacy problems arising from the use of biosimilars.
Authors and Affiliations
Canna Jagdish Ghia, Gautam Rambhad, U. R. K. Rao
Keywords
Related Articles
- EP ID EP340791
- DOI 10.9734/BJMMR/2016/21588
- Views 63
- Downloads 0
Commercial Drivers’ Participation in the Use of Family Planning Services in Ibadan, Southwest Nigeria
Aims: To determine the participation of male commercial drivers in the choice and use of family planning methods and possible implications for reproductive health policy formulation. Study Design: A cross-sectional stud...
Prevalence of Hepatitis B and Hepatitis C Infections in HIV Infected Patients Attending a Tertiary Care Hospital in North-East India
Aims: To study the co infection of Hepatitis B (HBV) and/or Hepatitis C virus (HCV) in Human Immunodeficiency Virus (HIV) infected patients attending tertiary care teaching hospital in North East India. Study Design: Th...
Regenerated Bisphosphonate Related Osteonecrosis of the Jaws: Clinical Data of Eleven Cases
Aims: Bisphosphonate-related osteonecrosis of the jaw (BRONJ) is defined as the persistence of exposed necrotic bone in the oral cavity for 8 weeks or more in patients with current or previous history of BP use, despite...
Mild Hypothermia Attenuates the Excitatory Amino Acids Overflow and Diminishes the Nitric Oxide Synthase Activity during Reperfusion after Asphyxial Cardiac Arrest in Rats
Aims: Neurotransmitter overflow into the extracellular space and activation of nitric oxide synthase were implicated in neuronal death after cerebral ischemia. A small temperature reduction induced after the insult cruci...
Clinical Features of Immunological Dysregulation in Common Variable Immunodeficiency in Iran
Background: Common Variable Immune Deficiency (CVID) is a primary immunodeficiency with significant clinical manifestations. The aim of this study was to evaluate the clinical and immunological characteristics of CVID pa...