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Bioequivalence

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In medicine and pharmacology, bioequivalence, or therapeutic equivalency, is "the relative equivalency in the efficacy of different modes of treatment of a disease, most often used to compare the efficacy of different pharmaceuticals to treat a given disease."[1]

Pharmaceutical bioequivalence

In the United States, the Office of Generic Drugs of Food and Drug Administration (FDA) is dedicated to "dedicated to approving safe, effective, high-quality and bio-equivalent generic drug products for use by consumers".[2] The approval process for generic drugs began in the late 1960s. Generic drug manufacturers are required to prove that their formulation exhibits bioequivalence to the innovator product.

In a systematic review of drugs used for cardiovascular disease, 35 of 38 randomized controlled trials found bioequivalence.[3] The same study also found that in spite of these results, 53% of published editorials on the topic "expressed a negative view of generic drug substitution".

A second study addressed the bioequivalenc] of the anticoagulant warfarin has been only available under the trade name Coumadin in North America until recently. Warfarin has a narrow therapeutic window and requires frequent blood tests of the International Normalized Ratio (INR) to make sure patients do not have a subtherapeutic or a toxic level. A study showed that replacing Coumadin with generic warfarin was safe.[4]

Generic drugs have been recalled for lack of bioequivalence.[5][6]

References

  1. Anonymous (2019), Bioequivalence (English). Medical Subject Headings. U.S. National Library of Medicine.
  2. Anonymous. Welcome to the Office of Generic Drugs. Food and Drug Administration. Retrieved on 2009-02-01.
  3. Kesselheim AS, Misono AS, Lee JL, et al (December 2008). "Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis". JAMA 300 (21): 2514–26. DOI:10.1001/jama.2008.758. PMID 19050195. Research Blogging.
  4. Pereira JA, Holbrook AM, Dolovich L, Goldsmith C, Thabane L, Douketis JD, Crowther MA, Bates SM, Ginsberg JS. (2005). "Are brand-name and generic warfarin interchangeable? Multiple n-of-1 randomized, crossover trials.". Ann Pharmacother 39 (7-8): 1188-93. PMID 15914517.
  5. ETHEX Corporation Issues Nationwide Voluntary Recall of Products. Food and Drug Administration (2009). Retrieved on 2009-01-29.
  6. ETHEX Corporation Initiated Nationwide Voluntary Recall of a Single Lot of Hydromorphone HCl 2 mg Tablets Due to Potential for Oversized Tablet (2008). Retrieved on 2009-01-29.