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Biologic product identification and US pharmacovigilance in the biosimilars era

Nature Biotechnology volume 32, pages 128–129 (2014)Cite this article

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To the Editor

The first approval of a biosimilar by the US Food and Drug Administration (FDA) could occur by the end of 2014 (ref. 1). Although biosimilars must demonstrate no clinically meaningful differences from their biologic reference products in terms of safety, purity and potency (per US law2), they are not expected to be identical because of the inherent complexity of biologics and differences in manufacturing. Therefore, the FDA recommends clinical efficacy and/or safety studies of biosimilars before approval; however, such studies may not be large enough to assess rare adverse events (e.g., as related to neutralizing antibodies)3. Consequently, robust post-approval surveillance of biosimilars in the United States to monitor their safety is critical. We consider that such a pharmacovigilance system requires unambiguous product identifiers that distinguish all biologics from one another to accurately trace adverse events to the correct product and to identify potential differences in safety profiles after approval. A recent case study demonstrates inconsistencies in biologic identification in the US pharmacovigilance system that limit accurate tracing of reported adverse events to the administered product when multiple manufacturers exist (see examples below)4.

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References

  1. IMS Health. Shaping the Biosimilars Opportunity: A Global Perspective on the Evolving Biosimilars Landscape. http://www.imshealth.com/ims/Global/Content/Home%20Page%20Content/IMS%20News/Biosimilars_Whitepaper.pdf (IMS Health, London, 2011; accessed January 17, 2014).

  2. Biologics Price Competition and Innovation Act of 2009. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM216146.pdf (accessed 21 October 2013).

  3. US Food and Drug Administration. Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (FDA; Rockville, MD, 2012).

  4. Government Accountability Office. Food and Drug Administration Response to Heparin Contamination Helped Protect Public Health; Controls That Were Needed for Working with External Entities Were Recently Added (GAO; Washington, DC, 2010).

  5. Olson, K. Alliance for Safe Biologic Medicine—Prescriber Survey. http://safebiologics.org/resources/wp-content/uploads/2012/09/ASBM-Survey-2.pdf (ISR, 2012; accessed 21 October 2013).

  6. Vermeer, N. et al. Traceability of biologicals in adverse event reporting systems. Presented at 28th International Conference on Pharmacoepidemiology and Therapeutic Risk Management, Barcelona, Spain, 23–26 August 2012.

  7. Booz Allen Hamilton. Evaluation of Potential Data Sources for the FDA Sentinel Initiative–Final Report. US Food and Drug Administration Contract No. HHSF223200831321P (Booz Allen Hamilton, Rockville, MD, 2010). http://www.regulations.gov/contentStreamer?objectId=0900006480e6cd8d&disposition=attachment&contentType=pdf (accessed 17 January 2014).

  8. US Food and Drug Administration. Part 15 Public Hearing on Approval Pathway for Biosimilar and Interchangeable Biological Products. (FDA, Silver Spring, MD, November 2, 2010). http://www.fda.gov/downloads/Drugs/NewsEvents/UCM289130.pdf (FDA, Silver Spring, MD, 2 November 2010; accessed 17 January 2014).

  9. Getz, K.A., Stergiopoulos, S. & Kaitin, K.I. Am. J. Ther. 10.1097/MJT.0b013e318262316f (24 September 2012)

  10. US Food and Drug Administration. Proprietary Name Review(s): BLA 125294 – [xxx]-Filgrastim (FDA, Center for Drug Evaluation and Research, Rockville, MD, 2012).

  11. US Food and Drug Administration. Approval package for application number 125418Orig1s000 (ziv-aflibercept) (FDA, Silver Spring, MD, 2012).

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Acknowledgements

The authors thank J. Balwit, whose work was funded by Amgen Inc., for assistance in the preparation of this manuscript and P. Seligman for his review and input.

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Authors and Affiliations

  1. Amgen Inc., Washington, DC, USA

    Thomas Felix

  2. Amgen Inc., Zug, Switzerland

    Torbjörn T Johansson

  3. Amgen Inc., Thousand Oaks, California, USA

    Jodi A Colliatie & Michael R Goldberg

  4. Onyx Pharmaceuticals, UK Limited, Birmingham, UK

    Andrew R Fox

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Correspondence to Thomas Felix.

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Competing interests

T.F., J.A.C. and M.R.G. are employees of and own stock in Amgen Inc. T.T.J. was a paid consultant to Amgen Inc. A.R.F. is an employee of Onyx Pharmaceuticals UK Limited (a subsidiary of Amgen Inc.) and owns stock in Amgen Inc.

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Felix, T., Johansson, T., Colliatie, J. et al. Biologic product identification and US pharmacovigilance in the biosimilars era. Nat Biotechnol 32, 128–129 (2014). https://doi.org/10.1038/nbt.2823

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