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.

A comprehensive review addressing the factors influencing generic drug substitution

“…16 Nevertheless, this involves substituting the same chemical or biological entity at the exact dosage and pharmaceutical form with another product, presenting the same quality, efficacy, and safety profiles. 1,6 Once the marketing authorization file of a generic drug has been accepted, the national regulatory authority can register it, which allows doctors to prescribe it and pharmacists to consider it for substitution. 17,18 The bioequivalence studies guarantee the efficacy of a generic drug identical to that of the originator, but its tolerance may be different due to the disparity of excipients with known effects.…”

Assessment of community pharmacists’ knowledge of the differences between generic drugs and biosimilars: A pilot cross-sectional study

“…1,2 Generic drugs are copies of small chemical molecules identical to the brand drug in dose, form, safety, strength, mode of administration, quality, and indication. 2,3 However, biosimilars are highly similar to large, complex biologic drugs in terms of characteristics, biological activity, safety, and efficacy and require complex and expensive development. 4 Equivalence studies performed on generic Assessment of community pharmacists' knowledge of the differences between generic drugs and biosimilars: A pilot cross-sectional study drugs are insufficient to secure therapeutic equivalence of biosimilars due to differences in their pharmacodynamics, leading to possible batch-to-batch variability.…”

“…As part of a general policy to reduce medical expenditures, governments encouraged the prescription and use of generic drugs and biosimilars, known to be cheaper than their reference drug. 1,2 Generic drugs are copies of small chemical molecules identical to the brand drug in dose, form, safety, strength, mode of administration, quality, and indication. 2,3 However, biosimilars are highly similar to large, complex biologic drugs in terms of characteristics, biological activity, safety, and efficacy and require complex and expensive development.…”

Lebanese pharmacists’ knowledge of generic drugs and factors affecting their use and selection following the pandemic and the economic crisis: A pilot cross-sectional study

“…3–5 Among others, many governments adopted the promotion of the use of generics and biosimilars. 6,7 The prescription of generic drugs provides a cost-effective solution to the high price of brands while conserving their quality and efficacy, resulting in considerable savings to healthcare budgets. 8,9…”

“…[3][4][5] Among others, many governments adopted the promotion of the use of generics and biosimilars. 6,7 The prescription of generic drugs provides a cost-effective solution to the high price of brands while conserving their quality and efficacy, resulting in considerable savings to healthcare budgets. 8,9 Generic drugs usually offer a well-established safety profile, equivalent to that of the originator, and are subject to the same regulated supervision with pharmacovigilance regulations as stringent as for originator drugs.…”