Requirements for generic antiepileptic medicines: A clinical perspective

Journal of Neurology

Volumn 258, Issue 12, 2011, Pages 2128-2132

  Trinka, Eugen ^a   Krämer, Günter ^b   Graf, Martin ^c  

^a PARACELSUS MEDICAL UNIVERSITY   (Austria)

^b Swiss Epiklinik   (Switzerland)

^c Department of Neurology ^*  (Austria)

Author keywords

Antiepileptic drugs; Bioequivalence; Epilepsy; Generics; Health economy

Indexed keywords

ANTICONVULSIVE AGENT; CLOBAZAM; GENERIC DRUG; LAMOTRIGINE; PHENYTOIN; TOPIRAMATE; VALPROIC ACID;

ANTICONVULSANT THERAPY; AREA UNDER THE CURVE; BIOEQUIVALENCE; BREAKTHROUGH SEIZURE; COST CONTROL; DRUG BIOAVAILABILITY; DRUG COST; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG QUALITY; DRUG SAFETY; DRUG SUBSTITUTION; EPILEPSY; HEALTH CARE COST; HUMAN; MAXIMUM PLASMA CONCENTRATION; PATIENT SAFETY; PRESCRIPTION; PRIORITY JOURNAL; REVIEW; SEIZURE; UNSPECIFIED SIDE EFFECT;

ANTICONVULSANTS; DRUGS, GENERIC; EPILEPSY; HUMANS; THERAPEUTIC EQUIVALENCY;

EID: 83255191702     PISSN: 03405354     EISSN: 14321459     Source Type: Journal    
DOI: 10.1007/s00415-011-6126-6     Document Type: Review

References (41)

1. Andermann F, Duh MS, Gosselin A, Paradis PE (2007) Compulsory generic switching of antiepileptic drugs: high switchback rates to branded compounds compared with other drug classes. Epilepsia 48:464-469 (Pubitemid 46365174)
2. Anderson S, Hauck WW (1990) Consideration of individual bioequivalence. J Pharmacokinet Biopharm 18:259-273 (Pubitemid 20308933)
3. Andlin-Sobocki P, Jonsson B, Wittchen HU, Olesen J (2005) Cost of disorders of the brain in Europe. Eur J Neurol 12(Suppl 1):1-27
4. Berg MJ (2007) What's the problem with generic antiepileptic drugs? A call to action. Neurology 68:1245-1246 (Pubitemid 46625966)
5. Bialer M (2007) Generic products of antiepileptic drugs (AEDs): is it an issue? Epilepsia 48:1825-1832 (Pubitemid 47537455)
6. Bialer M, Midha KK (2010) Generic products of antiepileptic drugs: a perspective on bioequivalence and interchangeability. Epilepsia 51:941-950
7. Bialer M, Yacobi A, Moros D, Levitt B, Houle JM, Munsaka MS (1998) Criteria to assess in vivo performance and bioequivalence of generic controlled-release formulations of carbamazepine. Epilepsia 39:513-519 (Pubitemid 28221808)
8. Borgheini G (2003) The bioequivalence and therapeutic efficacy of generic versus brand-name psychoactive drugs. Clin Ther 25:1578-1592
9. Chen ML (1997) Individual bioequivalence-a regulatory update. J Biopharm Stat 7:5-11
10. Chen ML, Lesko LJ (2001) Individual bioequivalence revisited. Clin Pharmacokinet 40:701-706 (Pubitemid 33027886)
11. Chen ML, Patnaik R, Hauck WW, Schuirmann DJ, Hyslop T, Williams R (2000) An individual bioequivalence criterion: regulatory considerations. Stat Med 19:2821-2842
12. Chen ML, Shah V, Patnaik R, Adams W, Hussain A, Conner D, Mehta M, Malinowski H, Lazor J, Huang SM, Hare D, Lesko L, Sporn D, Williams R (2001) Bioavailability and bioequivalence: an FDA regulatory overview. Pharm Res 18:1645-1650 (Pubitemid 34020417)
13. Crawford P, Feely M, Guberman A, Kramer G (2006) Are there potential problems with generic substitution of antiepileptic drugs? A review of issues. Seizure 15:165-176
14. Davit BM, Conner DP, Fabian-Fritsch B, Haidar SH, Jiang X, Patel DT, Seo PR, Suh K, Thompson CL, Yu LX (2008) Highly variable drugs: observations from bioequivalence data submitted to the FDA for new generic drug applications. AAPS J 10:148-156
15. Davit BM, Nwakama PE, Buehler GJ, Conner DP, Haidar SH, Patel DT, Yang Y, Yu LX, Woodcock J (2009) Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration. Ann Pharmacother 43:1583-1597
16. Duh MS, Paradis PE, Latremouille-Viau D, Greenberg PE, Lee SP, Durkin MB, Wan GJ, Rupnow MF, LeLorier J (2009) The risks and costs of multiple-generic substitution of topiramate. Neurology 72:2122-2129
17. Guberman A, Corman C (2000) Generic substitution for brand name antiepileptic drugs: a survey. Can J Neurol Sci 27:37-43 (Pubitemid 30126864)
18. Haas JS, Phillips KA, Gerstenberger EP, Seger AC (2005) Potential savings from substituting generic drugs for brand-name drugs: medical expenditure panel survey, 1997-2000. Ann Intern Med 142:891-897
19. Haidar SH, Davit B, Chen ML, Conner D, Lee L, Li QH, Lionberger R, Makhlouf F, Patel D, Schuirmann DJ, Yu LX (2008)Bioequivalence approaches for highly variable drugs and drug products. Pharm Res 25:237-241
20. Haidar SH, Makhlouf F, Schuirmann DJ, Hyslop T, Davit B, Conner D, Yu LX (2008) Evaluation of a scaling approach for the bioequivalence of highly variable drugs. AAPS J 10:450-454
21. Hauck WW, Anderson S (1991) Individual bioequivalence: what matters to the patient. Stat Med 10:959-960
22. Hauck WW, Anderson S (1992) Types of bioequivalence and related statistical considerations. Int J Clin Pharmacol Ther Toxicol 30:181-187
23. Hauck WW, Anderson S (1994) Measuring switchability and prescribability: when is average bioequivalence sufficient? J Pharmacokinet Biopharm 22:551-564
24. Hauck WW, Bois FY, Hyslop T, Gee L, Anderson S (1997) A parametric approach to population bioequivalence. Stat Med 16:441-454 (Pubitemid 27073012)
25. Hauck WW, Hyslop T, Chen ML, Patnaik R, Williams RL (2000) Subject-by-formulation interaction in bioequivalence: conceptual and statistical issues. FDA Population/Individual Bioequivalence Working Group. Food and Drug Administration. Pharm Res 17:375-380
26. Heaney DC, Sander JW (2007) Antiepileptic drugs: generic versus branded treatments. Lancet Neurol 6:465-468 (Pubitemid 46551869)
27. Henney JE (1999) From the Food and Drug Administration. JAMA 282:1995
28. Kramer G, Biraben A, Carreno M, Guekht A, de Haan GJ, Jedrzejczak J, Josephs D, van RK, Zaccara G (2007) Current approaches to the use of generic antiepileptic drugs. Epilepsy Behav 11:46-52 (Pubitemid 47087191)
29. Kramer G, Denning D, Schmidt D, For the Ad Hoc Kommission der Deutschen Gesellschaft für Neurologie (2005) Generika in der Epileptologie: Was ist zu beachten? Aktuelle Neurologie 32:275-278 (Pubitemid 40911022)
30. LeLorier J, Duh MS, Paradis PE, Lefebvre P, Weiner J, Manjunath R, Sheehy O (2008) Clinical consequences of generic substitution of lamotrigine for patients with epilepsy. Neurology 70:2179-2186
31. Midha KK, Rawson MJ, Hubbard JW (1997) Individual and average bioequivalence of highly variable drugs and drug products. J Pharm Sci 86:1193-1197 (Pubitemid 27486085)
32. Midha KK, Rawson MJ, Hubbard JW (1998) Bioequivalence: switchability and scaling. Eur J Pharm Sci 6:87-91 (Pubitemid 28164277)
33. Midha KK, Rawson MJ, Hubbard JW (1999) Prescribability and switchability of highly variable drugs and drug products. J Control Release 62:33-40 (Pubitemid 29486479)
34. Nightingale SL, Morrison JC (1987) Generic drugs and the prescribing physician. JAMA 258:1200-1204
35. Perucca E, Albani F, Capovilla G, Bernardina BD, Michelucci R, Zaccara G (2006) Recommendations of the Italian League against Epilepsy working group on generic products of antiepileptic drugs. Epilepsia 47(Suppl 5):16-20 (Pubitemid 44924186)
36. Pugliatti M, Beghi E, Forsgren L, Ekman M, Sobocki P (2007) Estimating the cost of epilepsy in Europe: a review with economic modeling. Epilepsia 48:2224-2233 (Pubitemid 350243405)
37. Sander JW (2003) The epidemiology of epilepsy revisited. Curr Opin Neurol 16:165-170 (Pubitemid 36521202)
38. Schall R, Luus HG (1992) Comparison of absorption rates in bioequivalence studies of immediate release drug formulations. Int J Clin Pharmacol Ther Toxicol 30:153-159
39. Schall R, Luus HG (1993) On population and individual bioequivalence. Stat Med 12:1109-1124 (Pubitemid 23213960)
40. Wilner AN (2004) Therapeutic equivalency of generic antiepileptic drugs: results of a survey. Epilepsy Behav 5:995-998 (Pubitemid 40003924)
41. Zachry WM III, Doan QD, Clewell JD, Smith BJ (2009) Casecontrol analysis of ambulance, emergency room, or inpatient hospital events for epilepsy and antiepileptic drug formulation changes. Epilepsia 50:493-500