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Pharmacoepidemiol Drug Saf. 2020 Jul;29(7):811-813. doi: 10.1002/pds.4885. Epub 2019 Aug 11.

Barriers and facilitators to conduct high-quality, large-scale safety and comparative effectiveness research: The Biologics and Biosimilars Collective Intelligence Consortium experience.

Pharmacoepidemiology and drug safety

Catherine M Lockhart, Cara L McDermott, Thomas Felix, Nancy D Lin, Mark J Cziraky, Aaron B Mendelsohn, Jeffrey S Brown

Affiliations

  1. Biologics and Biosimilars Collective Intelligence Consortium, Academy of Managed Care Pharmacy, Alexandria, VA, USA.
  2. Intercontinental Medical Affairs, Amgen, Thousand Oaks, CA, USA.
  3. Epidemiology, OptumInsight Inc, Eden Prairie, MN, USA.
  4. Research Development and Operations, HealthCore, Wilmington, DE, USA.
  5. Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.

PMID: 31402533 DOI: 10.1002/pds.4885

[No abstract available.]

References

  1. Koyfman H. Biosimilarity and interchangeability in the Biologics Price Competition and Innovation Act of 2009 and FDA's 2012 draft guidance for industry. Biotechnol Law Rep. 2013;32(4):238-251. - PubMed
  2. Hemmington A, Dalbeth N, Jarrett P, et al. Medical specialists' attitudes to prescribing biosimilars. Pharmacoepidemiol Drug Saf. 2017;26(5):570-577. - PubMed
  3. Jacobs I et al. Patient attitudes and understanding about biosimilars: an international cross-sectional survey. Patient Prefer Adherence. 2016;10:937-948. - PubMed
  4. Sentinel. 2019 [cited 2019 April 25]; Available from: https://www.sentinelinitiative.org/. - PubMed
  5. Biologics and Biosimilars Collective Intelligence Consortium. 2019 [cited 2019 April 25]; Available from: http://www.bbcic.org. - PubMed
  6. McMahill-Walraven C et al. Differentiation of adults with type 1 versus type 2 diabetes in administrative claims analysis: experience from the Biologics and Biosimilars Collective Intelligence Consortium. in AMCP Nexus; October 2018; Orlando, FL. - PubMed
  7. The World Bank Group. Population ages 65 and above (% of total). 2017 Revision [cited 2019 May 8]; Available from: https://data.worldbank.org/indicator/SP.POP.65UP.TO.ZS?end=2017&locations=US&start=1960&view=chart. - PubMed
  8. Jackson, T. Does Medicare cover dialysis? 2019 April 4, 2019 [cited 2019 May 9]; Available from: https://medicare.com/coverage/medicare-cover-dialysis/. - PubMed
  9. Biologics & Biosimilars Collective Intelligence Consortium, Data on file. 2018. - PubMed
  10. He M et al. ICD-9 to ICD-10 mapping for database research in originator biologics and biosimilars. in AMCP Nexus; October 2018; Orlando, FL. - PubMed
  11. Zhang, J., et al. Capture of biologic and biosimilar dispensings in a consortium of U.S.-based claims databases-utilization of National Drug Codes and HCPCS modifiers in medical claims. in AMCP Annual Meeting. 2019. San Diego, CA. - PubMed
  12. Centers for Medicare & Medicaid Services. Medicare part B drug average sales price: part B biosimilar biological product payment and required modifiers. 2018 [cited 2019 April 29]. - PubMed
  13. Flory JH et al. Missing laboratory results data in electronic health databases: implications for monitoring diabetes risk. J Comp Eff Res. 2017;6(1):25-32. - PubMed
  14. Raebel MA, Shetterly S, Lu CY, et al. Methods for using clinical laboratory test results as baseline confounders in multi-site observational database studies when missing data are expected. Pharmacoepidemiol Drug Saf. 2016;25(7):798-814. - PubMed
  15. McMahill-Walraven, C., et al. Descriptive analysis of the use of long- and intermediate-acting insulin, and key safety outcomes in adults with diabetes mellitus. In: AMCP Nexus; October 2018; Orlando, FL. - PubMed

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