Drug Safety

, Volume 40, Issue 2, pp 105–108 | Cite as

Active Surveillance of Follow-on Biologics: A Prescription for Uptake

  • Ameet Sarpatwari
  • Joshua J. Gagne
  • Nicole L. Levidow
  • Aaron S. Kesselheim
Current Opinion

Abstract

As lower-cost versions of original biologic drugs made by different manufacturers, follow-on biologics offer the promise of meaningful savings for the US health care system and improved patient health outcomes through greater medication adherence. Fulfillment of this promise, however, is predicated on the prescribing of such products. Under state drug product selection laws, pharmacists may substitute prescriptions for brand name, small-molecule drugs with their generic equivalents, but will be indefinitely prohibited from substituting prescriptions for original biologics with their follow-on biologic counterparts given a lack of product-specific guidance on demonstrating interchangeability. Even when interchangeable follow-on biologics become available, they will face heightened barriers to substitution following the enactment of so-called carve-outs in several states. Data collected to date suggest that a substantial proportion of US physicians remain skeptical of follow-on biologics despite their long record of safe and effective use in Europe. Active surveillance of follow-on biologics within the US market using insurance claims databases can help address this skepticism and help answer key questions concerning the safety of switching between original and follow-on products or between different follow-on products, and of extrapolating to broader indications. Funding is needed to support such surveillance activities and to disseminate the findings to key stakeholders.

References

  1. 1.
    Observations on trends in prescription drug spending. ASPE Issue Brief. March 8, 2016. https://aspe.hhs.gov/sites/default/files/pdf/187586/Drugspending.pdf. Accessed 4 Oct 2016.
  2. 2.
    Patient Protection and Affordable Care Act, Pub. L. No. 111–148, Title VII, Subtitle A, 124 Stat. 119, 804–21 (2010).Google Scholar
  3. 3.
    Westgate A. Five specialty pharmaceutical trends to watch. Managed Healthcare Executive. October 5, 2016. http://managedhealthcareexecutive.modernmedicine.com/managed-healthcare-executive/news/five-specialty-pharmaceutical-trends-watch. Accessed 5 Oct 2016.
  4. 4.
    Delivering on the potential of biosimilar medicines. IMS Institute for healthcare Informatics. March 2016. http://www.imshealth.com/files/web/IMSH%20Institute/Healthcare%20Briefs/Documents/IMS_Institute_Biosimilar_Brief_March_2016.pdf. Accessed 4 Oct 2016.
  5. 5.
    Shrank WH, Hoang T, Ettner SL, Glassman PA, Nair K, et al. The implications of choice: prescribing generic or preferred pharmaceuticals improves medication adherence for chronic conditions. Arch Intern Med. 2006;166:332–7.CrossRefPubMedGoogle Scholar
  6. 6.
    Gagne JJ, Choudhry NK, Kesselheim AS, Polinski JM, Hutchins D, Matlin OS, et al. Comparative effectiveness of generic and brand-name statins on patient outcomes: a cohort study. Ann Intern Med. 2014;161:400–7.CrossRefPubMedGoogle Scholar
  7. 7.
    Reading the signs: a roadmap for engaging physicians in the biosimilar discussion. Quantia. August 15, 2015. http://cdn2.hubspot.net/hubfs/436920/Whitepaper_-_Quantia_-_Reading_the_Signs_August_2015.pdf. Accessed 4 Oct 2016.
  8. 8.
    Grabowski D, Henderson B, Lam D, Keystone EC, Thorne C, Jamal S, et al. Attitudes towards subsequent entry biologics/biosimilars: a survey of Canadian rheumatologists. Clin Rheumatol. 2015;34:1427–33.CrossRefPubMedGoogle Scholar
  9. 9.
    Woodcock J, Griffin J, Behrman R, Cherney B, Crescenzi T, Fraser B, et al. The FDA’s assessment of follow-on protein products: a historical perspective. Nat Rev Drug Discov. 2007;6:437–42.CrossRefPubMedGoogle Scholar
  10. 10.
    Price WN 2nd, Rai AK. Drug development: are trade secrets delaying biosimilars. Science. 2015;348:188–9.CrossRefPubMedGoogle Scholar
  11. 11.
    Hunt D, Kavanagh D, Drummond I, et al. Thrombotic microangiopathy associated with interferon beta. N Engl J Med. 2014;370:1270–1.CrossRefPubMedPubMedCentralGoogle Scholar
  12. 12.
    42 U.S.C. § 262.Google Scholar
  13. 13.
    Sarpatwari A, Choudhry NK, Avorn J, Kesselheim AS. Paying physicians to prescribe generic drugs and follow-on biologics in the United States. PLoS Med. 2015;12:e1001802.CrossRefPubMedPubMedCentralGoogle Scholar
  14. 14.
    Mass. Gen. Laws ch. 112, § 12D.Google Scholar
  15. 15.
    Mass. Gen. Laws ch. 112, § 12EE.Google Scholar
  16. 16.
    Del. Code Ann. tit.24, § 2549.Google Scholar
  17. 17.
    Del. Code Ann. tit.24, § 2549A.Google Scholar
  18. 18.
    Ga. Code Ann. § 26-4-81.Google Scholar
  19. 19.
    N.C. Gen. Stat. § 90-85.28.Google Scholar
  20. 20.
    Stobaugh DJ, Deepak P, Ehrenpreis ED. Alleged isotretinoin-associated inflammatory bowel disease: disproportionate reporting by attorneys to the Food and Drug Administration Adverse Event Reporting System. J Am Acad Dermatol. 2013;69:393–8.CrossRefPubMedGoogle Scholar
  21. 21.
    Stergiopoulos S, Getz K. Evaluating AE reporting of two off-patent biologics to inform future biosimilar naming and reporting practices. Drug Saf. 2015;38:687–92.CrossRefPubMedGoogle Scholar
  22. 22.
    Schneeweiss S, Gagne JJ, Patrick AR, Choudhry NK, Avorn J. Comparative efficacy and safety of new oral anticoagulants in patients with atrial fibrillation. Circ Cardiovasc Qual Outcomes. 2012;5:480–6.CrossRefPubMedPubMedCentralGoogle Scholar
  23. 23.
    Solomon DH, Massarotti E, Garg R, Liu J, Canning C, Schneeweiss S. Association between disease-modifying antirheumatic drugs and diabetes risk in patients with rheumatoid arthritis and psoriasis. JAMA. 2011;305:2525–31.CrossRefPubMedGoogle Scholar
  24. 24.
    Gagne JJ, Kesselheim AS, Choudhry NK, Polinski JM, Hutchins D, Matlin OS, et al. Comparative effectiveness of generic versus brand-name antiepileptic medications. Epilepsy Behav. 2015;52(Pt A):14–8.Google Scholar
  25. 25.
    Medicare program; revisions to payment policies under the physician fee schedule and other revisions to Part B for CY 2016. Proposed rule. 80 Fed Regist. 2015;80:41686.Google Scholar
  26. 26.
    42 U.S.C. § 1395w-3a.Google Scholar
  27. 27.
    Medicare program; revisions to payment policies under the physician fee schedule and other revisions to Part B for CY 2016. Final rule with comment period. 80 Fed Regist. 2015;80:70886.Google Scholar
  28. 28.
    Implementation of biosimilar claim modifiers. Centers for Medicare and Medicaid Services. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R1542OTN.pdf. September 4, 2015. Accessed 4 Oct 2016.
  29. 29.
    Neupogen: highlights of prescribing. FDA. July 2015. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103353s5186lbl.pdf. Accessed 5 Oct 2016.
  30. 30.
    Zarxio: highlights of prescribing. FDA. March 2015. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125553lbl.pdf. Accessed 5 Oct 2016.
  31. 31.
    Gagne JJ, Avorn J, Shrank WH, Schneeweiss S. Refilling and switching of antiepileptic drugs and seizure-related events. Clin Pharmacol Ther. 2010;88:347–53.CrossRefPubMedPubMedCentralGoogle Scholar
  32. 32.
    Biologics and biosimilars collective intelligence consortium. Academy of Managed Care and Pharmacy. http://www.amcp.org/BBCIC/. Accessed 7 Nov 2016.
  33. 33.
    Kesselheim AS, Gagne JJ, Eddings W, Franklin JM, Ross KM, Fulchino LA, et al. Prevalence and predictors of generic drug skepticism among physicians: results of a national survey. JAMA Intern Med. 2016;176:845–7.CrossRefPubMedGoogle Scholar
  34. 34.
    Avoidable costs in U.S. health care. IMS Institute for Healthcare Informatics. June 2013. http://www.imshealth.com/files/web/IMSH%20Institute/Reports/Avoidable_Costs_in%20_US_Healthcare/IHII_AvoidableCosts_2013.pdf. Accessed 4 Oct 2016.
  35. 35.
    Effects of therapeutic class on generic drug substitution. Department of Health and Human Services. April 25, 2014. http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-14-014.html. Accessed 4 Oct 2016.
  36. 36.
    Educating groups influencing generic drug use. Department of Health and Human Services. March 25, 2015. http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-15-013.html. Accessed 4 Oct 2016.

Copyright information

© Springer International Publishing Switzerland 2016

Authors and Affiliations

  • Ameet Sarpatwari
    • 1
  • Joshua J. Gagne
    • 1
  • Nicole L. Levidow
    • 1
  • Aaron S. Kesselheim
    • 1
  1. 1.From the Program On Regulation, Therapeutics And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of MedicineBrigham and Women’s Hospital and Harvard Medical SchoolBostonUSA

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