Biosimilars and Identification of Biosimilarity

Abstract

Drugs developed by complex molecules of living cells either plants, animals, human cell lines or microorganisms are called biologics. These biologics are specific, patented, approved by FDA and are considered better than generic drugs which are made from chemical synthesis in terms of targeting and side effects, these medications have their fair share of value in the market which makes it difficult to be available for fair prices. In this scenario, biosimilars are the drugs that play vital role by fulfilling the clinical function of its reference drug while being cost effective. Biosimilars are the drugs developed highly similar yet not identical to reference drug such that it plays similar functions as biologic in terms of efficiency and safety. Biosimilars and biologic drugs come in a variety of ways, including monoclonal antibodies and growth factors. Their ability to precisely target signaling pathways and cells is revolutionizing the fight against cancer and inflammation, among other diseases. Biosimilars, as potential substitutes for reference biologics, can help to expand treatment options and meet the increasing demand for biologic therapies. There are certain set of criteria to consider developing a biosimilar. Bio-similarity is identified by a series of analytical techniques with additional orthogonal techniques to test the proposed similarity with the reference. These methodologies are governed by parameters set by FDA to ensure the safety and efficiency of the biosimilar for treatment of purposed disease