Comparing Generic and Innovator Drugs: A Review of 12 Years of Bioequivalence Data from the United States Food and Drug Administration

Davit, Barbara M.; Nwakama, Patrick E.; Buehler, Gary; Conner, Dale P.; Haidar, Sam; Patel, Devvrat T.; Yang, Yongsheng; Yu, Lawrence X.; Woodcock, Janet

doi:10.1345/aph.1m141

Cited by 289 publications

(245 citation statements)

References 40 publications

(38 reference statements)

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“…Relative magnitudes of clinical studies for generic medicines 64, biosimilar LY insulin glargine 32, 35, 37, 38, 41, 43 and new molecular entities 65. The sizes of the circles do not necessarily represent the relative sizes of the trials between categories.…”

Section: Differences Between Biosimilar and Generic Medicinesmentioning

confidence: 99%

Introduction of biosimilar insulins in Europe

et al. 2017

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Regulatory approval of the first biosimilar insulin in Europe, LY2963016 insulin glargine (Abasaglar®), in 2014 expanded the treatment options available to people with diabetes. As biosimilar insulin products come to market, it is important to recognize that insulin products are biologicals manufactured through complex biotechnology processes, and thus biosimilar insulins cannot be considered identical to their reference products. Strict regulatory guidelines adopted by authorities in Europe, the USA and some other countries help to ensure that efficacy and safety profiles of biosimilar insulins are not meaningfully different from those of the reference products, preventing entry of biological compounds not meeting quality standards and potentially affecting people's glycaemic outcomes. This review explains the concept of biosimilar medicines and outlines regulatory requirements for registration of biosimilar insulins in Europe, which is illustrated by the successful development of LY2963016 insulin glargine and MK‐1293 insulin glargine (Lusduna®). Preclinical and clinical comparative studies of the biosimilar insulin glargine programmes include in vitro bioassays for insulin and insulin‐like growth factor 1 receptor binding, assessment of in vitro biological activity, evaluation of pharmacokinetic/pharmacodynamic profiles in phase I studies and assessment of long‐term safety and efficacy in phase III studies. The emergence of biosimilar insulins may help broaden access to modern insulins, increase individualized treatment options and reduce costs of insulin therapy.

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Section: Differences Between Biosimilar and Generic Medicinesmentioning

confidence: 99%

Introduction of biosimilar insulins in Europe

et al. 2017

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“…In a review of 12 years of bioequivalence data, the FDA found that the criteria used to evaluate generic drugs leads to the approval of generic versions that are bioequivalent to their brand counterparts within a narrow margin [6]. However, some drug products may have unique structural or functional attributes that necessitate product-specific approaches to therapeutic equivalence determinations.…”

Section: The Use Of Product-specific Therapeutic Equivalence Standardsmentioning

confidence: 99%

Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness

Kesselheim

Gagne

2015

Drug Saf

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Generic drugs possessing the same active ingredients, dosage form, strength, route of administration, and labeling can be approved by the US Food and Drug Administration (FDA) as interchangeable with a brandname drug without needing to repeat the formal Phase I, II, and III clinical trials conducted by the original manufacturers. In recent years, the FDA has approved several generic drugs using product-specific testing to determine therapeutic equivalence in accordance with the unique features of the particular drug. These have been used in two primary situations: (1) cases for which certain bioequivalence studies were not relevant; and (2) cases of complex molecules that may require specially tailored pharmaceutical equivalence studies. Examples include venlafaxine extended release, acarbose, vancomycin capsules, sodium ferric gluconate, salmon calcitonin nasal spray, and enoxaparin. Product-specific approaches to demonstrating therapeutic equivalence are essential to avoid delays in low-cost generic drug availability but can have important clinical implications; yet, currently, there is no formal process in place to monitor the safety and effectiveness of generic drugs approved using modified regulatory pathways. Several strategies can be used to monitor the safety and effectiveness of generic drugs approved via productspecific determinations of therapeutic equivalence.

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“…2 Generic drugs offer a powerful approach to cost savings for the patients. As a result patient compliance to the treatment increases.…”

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confidence: 99%

“…As a result patient compliance to the treatment increases. 1,2 In the year 2008 alone, generic drugs accounted for 69% of all prescriptions dispensed in the USA, yet only 16% of the cost in US dollar were spent on such prescriptions. 2 All prescriptions and over-the-counter generic drugs marketed in the USA must meet standards set by the US FDA.…”

mentioning

confidence: 99%

“…1,2 In the year 2008 alone, generic drugs accounted for 69% of all prescriptions dispensed in the USA, yet only 16% of the cost in US dollar were spent on such prescriptions. 2 All prescriptions and over-the-counter generic drugs marketed in the USA must meet standards set by the US FDA. In approving a new generic drug for marketing, the FDA concludes that it is therapeutically equivalent to its corresponding reference product (usually the innovator product, but may be sometimes another generic product if the innovator product was withdrawn).…”

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confidence: 99%

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