Assessment of the differences between generic and biosimilar drugs: A brief literature review

Abstract

Generic Drugs are copies of small chemical drugs identical to their reference drug by dose, form, safety, strength, mode of administration, quality, performance, and intended purpose. They have been on the market for a long time and have abbreviated pathways to be approved. Their development is more simple and more affordable than their reference counterpart, which makes them widely used by patients. More recently, biosimilars were introduced to the market with strict regulations. They are highly similar to large, complex molecules, known as biological drugs, in terms of quality characteristics, biological activity, safety, and efficacy. Their development is complex and expensive, where clinical trials are necessary. Even though generic drugs and biosimilars are both copies of a reference drug, they differ in many aspects. Misconceptions or misinformation among healthcare stakeholders could have limited their use. Therefore, this short review aims to compare generic drugs and biosimilars in terms of characteristics, development, regulation, and interchangeability with brand drugs. Findings from this report can help clarify misconceptions and promote their use.