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Coping with the Regulatory Realities of Follow-on Biologics and the Nuances of US and European Regulations

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Abstract

It is well recognized that biopharmaceuticals provide great value in treating a number of chronic diseases but that the costs of these therapies have often been prohibitive. As patents and market exclusivity expire on a number of innovator products, there is an opportunity to develop follow-on versions of these products that have the potential to reduce health care costs worldwide. Presented here is a history of regulation, examples of approved molecules, terminology, and the current state of regulatory approaches open to follow-on biologics seeking market approval in the United States. Additionally, the regulations established by the European Union and the pending US legislation are reviewed. It is thought that new legislation will be available in the near future for the development of follow-on biologics that will facilitate improved competition in the US biopharmaceutical market.

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References

  1. 1.

    CBO nearly doubles estimated savings from generic biologics. FDA Week. December 26, 2008.

  2. 2.

    Insmed, Inc. Study by leading economist identifies potential for $378 billion of savings from follow on biologics [press release]. February 11, 2008. https://doi.org/investor.insmed.com/releasedetail.cfm?ReleaseID=293143.

  3. 3.

    European Generics Association. FAQ on biosimilar medicines, https://doi.org/www.egagenerics.com/FAQ-biosimilars.htm. Last accessed April 7, 2009.

  4. 4.

    European Parliament and Council Directive 2004/27/EC of 31 March 2004. OJ. April 30, 2004. L 136/34, https://doi.org/eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0034:0057:EN:PDF. Accessed April 9, 2009.

  5. 5.

    Covington and Burling LLP. 2006. FDA approval of Sandoz’s 505(b)(2) application for a follow-on recombinant human growth hormone product [Internet]. Cited June 25, 2009. https://doi.org/www.cov.com/files/Publication/8405cdb8-b5ca-4050-a2a7-84ea54b23aac/Presentation/PublicationAttachment/356e78e0-06fc-45e3-b0b8-9385b2b205b0/oid20985.pdf.

  6. 6.

    Woodcock J, Griffin J, Behrman R, et al. 2007. The FDA’s assessment of follow-on protein products: a historical perspective. Nat Rev Drug Discov. 6:437–442.

  7. 7.

    European Medicines Agency. Scientific guidelines Tor human medicinal products. Hiosimilars. https://doi.org/www.emea.europa.eu/htms/human/humanguidelines/multidiscipline.htm. Accessed April 7, 2009.

  8. 8.

    US Food and Drug Administration. CBER: frequently asked questions. https://doi.org/www.fda.gov/cber/faq.htm#3. Accessed June 12, 2008.

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Author information

Correspondence to Joel I. Folk.

Additional information

Joel I. Falk has disclosed that he has no financial relationships to disclose.

Ross A. Davidson has disclosed that he has no financial relationships to disclose.

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Folk, J.I., Davidson, R.A. Coping with the Regulatory Realities of Follow-on Biologics and the Nuances of US and European Regulations. Ther Innov Regul Sci 44, 137–145 (2010). https://doi.org/10.1177/009286151004400205

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Key Words

  • Biosimilar
  • Follow-on biologic or protein
  • Biogenetic
  • FDA regulation
  • EMEA regulation