Overview Of Biosimilar and General Consideration for Biosimilar Drug Development

Biological medicines, often produced by cutting-edge biotechnology, have transformed the outlook for patients with many chronic and often disabling conditions. An increasing number of biological medicines are ‘biosimilars’ - medicines highly similar in all essential aspects to an already approved biological medicine. The current article focus on the overview of Biosimilar medicine and its regulation. The Europe (EU) has pioneered the regulation of biosimilar medicines by establishing a solid framework for their approval and by shaping biosimilar development globally. USFDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. That means patients and health care professionals will be able to rely upon the safety (and effectiveness of the biosimilar or interchangeable product, just as they would the reference product. Patents for many branded biologics will expire during the next few years, allowing biosimilars manufacturers to seek FDA approval for generic versions of these agents.1 Since the EU approved the first biosimilar in 2006, healthcare professionals have gained increasing experience with their use. Today, biosimilars are an integral part of the effective biological therapies available in the EU, supported by adequate safeguards protecting patient safety. These criteria have inspired debate and the emergence of several critical issues, such as to what extent the biosimilars pathway should be abbreviated, how much clinical data should be required for approval, or when an agent should be designated as comparable or interchangeable with an originator biologic.2 These parameters will determine the ease and cost for a manufacturer to develop and market a biosimilar and will also ultimately influence the price of these medications.2 As healthcare professionals are at the forefront of patients’ care, it is vital that they have access to reliable information on these medicines: what they are and what scientific principles support their clinical development, approval and safety monitoring. Present article an efforts has been made with the important objective of development of the of biosimilars.