BIOSIMILARS: OPPORTUNITIES, CHALLENGES, AND THE GENERAL PRINCIPLES GOVERNING THEIR DEVELOPMENT AROUND THE GLOBE
DOI:
https://doi.org/10.22159/ijls.2021.v9i6.43430Keywords:
Biosimilars, Biologics, Regulatory Guidelines, Food and Drug Administration, European Medicines AgencyAbstract
Biologic drugs have revolutionized the treatment of many life-threatening and rare illnesses such as cancer and autoimmune diseases. Biologics are broadly referred as substances that are produced by living cells and are used in the treatment, prevention, or diagnosis of diseases. They include a wide range of substances, such as genetic material, antibodies, vaccines, or processes which act by influencing cellular processes that block disease or affect diseased cells. Biologics have become striking treatment options and the size of the market has grown hastily. It is expected that by 2023, most of the patents will expire in the European Union opening a large potential market. Keeping this in mind, the ability to launch substitutes to original biologics, also known as biosimilars, presents many opportunities to generic companies. The field of biosimilars seems to be “breaking” the traditional division between the creations of innovative NCE-based medicines by research-based companies, on the one hand, and, on the other hand, mapping of these medicines by the generic companies. The field of biosimilars so far presents some considerable challenges, namely, regulatory, safety, economic, and legal which are still being debated and discussed in different forums. In this article, we have tried to summarize the general principles and regulations governing the development of biosimilars by regulatory authorities such as the World Health Organization, European Medicines Agency, US Food and Drug Administration, and Health Canada. Furthermore, we have tried to throw some light on the opportunities, challenges, and current scenarios pertaining to biosimilars.
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