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Bioequivalence
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== Bioequivalence issues == While the FDA maintains that approved generic drugs are equivalent to their branded counterparts, bioequivalence problems have been reported by physicians and patients for many drugs.<ref name="Midha KK, McKay G 664β70">{{cite journal | vauthors = Midha KK, McKay G | title = Bioequivalence; its history, practice, and future | journal = The AAPS Journal | volume = 11 | issue = 4 | pages = 664β70 | date = December 2009 | pmid = 19806461 | pmc = 2782076 | doi = 10.1208/s12248-009-9142-z }}</ref> Certain classes of drugs are suspected to be particularly problematic because of their chemistry. Some of these include [[chiral drugs]], poorly absorbed drugs, and cytotoxic drugs. In addition, complex delivery mechanisms can cause bioequivalence variances.<ref name="Midha KK, McKay G 664β70"/> Physicians are cautioned to avoid switching patients from branded to generic, or between different generic manufacturers, when prescribing anti-epileptic drugs, [[warfarin]], and [[levothyroxine]].<ref name="Bate et al 2016">{{cite journal | vauthors = Bate R, Mathur A, Lever HM, Thakur D, Graedon J, Cooperman T, Mason P, Fox ER | display-authors = 6 | title = Generics Substitution, Bioequivalence Standards, and International Oversight: Complex Issues Facing the FDA | journal = Trends in Pharmacological Sciences | volume = 37 | issue = 3 | pages = 184β191 | date = March 2016 | pmid = 26687297 | doi = 10.1016/j.tips.2015.11.005 }}</ref> Major issues were raised in the verification of bioequivalence when multiple generic versions of FDA-approved generic drug were found not to be equivalent in efficacy and side effect profiles.<ref>http://www.raps.org/focus-online/news/news-article-view/article/3794/{{Dead link|date=July 2020 |bot=InternetArchiveBot |fix-attempted=yes }}</ref> In 2007, two providers of consumer information on nutritional products and supplements, [[ConsumerLab.com]] and The People's Pharmacy, released the results of comparative tests of different brands of bupropion.<ref name=peoples>{{cite web |url=http://www.peoplespharmacy.com/archives/generic_drug_problems/generic_drug_equality_questioned.php |title=Generic drug equality questioned |access-date=13 October 2007 |archive-date=20 October 2012 |archive-url=https://web.archive.org/web/20121020041011/http://www.peoplespharmacy.com/2007/10/12/generic-drug-eq/ |url-status=dead }}</ref> The People's Pharmacy received multiple reports of increased side effects and decreased efficacy of generic bupropion, which prompted it to ask ConsumerLab.com to test the products in question. The tests showed that some generic versions of Wellbutrin XL 300 mg didn't perform the same as the brand-name pill in laboratory tests.<ref name=msnbc>{{cite web |url=http://www.nbcnews.com/id/21142869 |archive-url=https://web.archive.org/web/20131011111651/http://www.nbcnews.com/id/21142869/ |url-status=dead |archive-date=11 October 2013 |title=Report questions generic antidepressant |access-date=13 October 2007 | vauthors = Stenson J |date=12 October 2007|work=[[NBC News]]}}</ref> The FDA investigated these complaints and concluded that the generic version is equivalent to Wellbutrin XL in regard to bioavailability of bupropion and its main active metabolite hydroxybupropion. The FDA also said that coincidental natural mood variation is the most likely explanation for the apparent worsening of depression after the switch from Wellbutrin XL to Budeprion XL.<ref name="urlReview of Therapeutic Equivalence: Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg">{{cite web |url=https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm153270.htm|archive-url=https://web.archive.org/web/20110606092603/https://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm153270.htm |archive-date=6 June 2011|title=Review of therapeutic equivalence: generic bupropion XL 300 mg and Wellbutrin XL 300 mg |website=[[Food and Drug Administration]] |access-date=19 April 2008 }}</ref> After several years of denying patient reports, in 2012 the FDA reversed this opinion, announcing that "Budeprion XL 300 mg fails to demonstrate therapeutic equivalence to Wellbutrin XL 300 mg."<ref name=PR_FDA20121023>{{cite press release |title=Budeprion XL 300 mg not therapeutically equivalent to Wellbutrin XL 300 mg |publisher=FDA |date=3 October 2012 |url=https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm322161.htm |archive-url=https://web.archive.org/web/20121006020843/http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm322161.htm? |url-status=dead |archive-date=6 October 2012 |access-date=23 March 2013}}</ref> The FDA did not test the bioequivalence of any of the other generic versions of Wellbutrin XL 300 mg, but requested that the four manufacturers submit data on this question to the FDA by March 2013. As of October 2013, the FDA has made determinations on the formulations from some manufacturers not being bioequivalent.<ref>{{cite web|title=FDA Update|url=https://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm322161.htm|archive-url=https://web.archive.org/web/20121006020843/http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm322161.htm|url-status=dead|archive-date=6 October 2012|publisher=FDA|access-date=15 June 2015|date=October 2013}}</ref> In 2004, [[Ranbaxy]] was revealed to have been falsifying data regarding the generic drugs they were manufacturing. As a result, 30 products were removed from US markets and Ranbaxy paid $500 million in fines. The FDA investigated many Indian drug manufacturers after this was discovered, and as a result at least 12 companies have been banned from shipping drugs to the US.<ref name="Bate et al 2016"/> In 2017, The [[European Medicines Agency]] recommended suspension of a number of nationally approved medicines for which bioequivalence studies were conducted by Micro Therapeutic Research Labs in India, due to inspections identifying misrepresentation of study data and deficiencies in documentation and data handling.<ref>{{Cite web|date=2017-03-24|title=EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs|url=https://www.ema.europa.eu/en/news/ema-recommends-suspension-medicines-due-unreliable-studies-micro-therapeutic-research-labs|access-date=2020-11-17|website=European Medicines Agency}}</ref>
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