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Why Biologics and Biosimilars Remain So Expensive: Despite Two Wins for Biosimilars, the Supreme Court’s Recent Rulings do not Solve Fundamental Barriers to Competition

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Biologics and biosimilars are medicines made from living cells that treat common and serious diseases such as cancer, diabetes, rheumatoid arthritis, and other inflammatory diseases. They are highly targeted, efficacious, and represent an increasingly important part of physicians’ armamentaria in the combat against these medical conditions. Yet they are extremely expensive, costing on average $10,000–$30,000 per year and exceed $500,000 for the most expensive biologics. The advent of biosimilar drugs, or high similar copies of biologics, was supposed to help reduce costs, but thus far the cost of treatment with biologics or biosimilars has not fallen sharply in the USA. We argue that a primary hurdle is the extent of patent protection for the reference biologics that impedes greater numbers of biosimilars entering into the market. To date, of the 12 biosimilars approved for marketing by the US Food and Drug Administration (FDA), only five are commercially available. All but one of the remaining biosimilars are withheld from commercialization due to patent disputes. We argue that the market for biologics and biosimilars will become price competitive only if more biosimilars are available to patients. To this end, the process to eliminate marginally inventive patents held by the reference drug makers must be streamlined and improved. In this perspective article, we suggest actions to improve the pre-FDA approval patent resolution process known as the patent dance, the streamlined patent invalidation process known as Inter Partes Reviews, and the process of granting patents.

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  1. Bennett CL, Chen B, Hermanson T, Wyatt MD, Schulz RM, Georgantopoulos P, et al. Regulatory and clinical considerations for biosimilar oncology drugs. Lancet Oncol. 2014;15(13):e594–605.

    Article  Google Scholar 

  2. Yang YT, Chen B, Bennett CL. Biosimilars—curb your enthusiasm. JAMA Oncol. 2017;3(11):1467–8.

    Article  Google Scholar 

  3. Mulcahy AW, Hlavka JP, Case SR. Biosimilar cost savings in the United States: initial experience and future potential. Rand Health Q. 2018;7(4):3.

    PubMed  PubMed Central  Google Scholar 

  4. Chen B, Yang YT, Bennett CL. Challenges to biosimilar substitution. Jama. 2017;318(12):1186.

    Article  Google Scholar 

  5. Chen B, Yang TY, Bennett C. Reply—Friction in the path to use of biosimilar drugs. N Engl J Med. 2018;378(22):2148.

    PubMed  Google Scholar 

  6. Frank RG. Friction in the path to use of biosimilar drugs. N Engl J Med. 2018;378(9):791–3.

    Article  Google Scholar 

  7. Sandoz Inc. v. Amgen Inc. 582 U.S. ___ 2017.

  8. Oil States Energy Services, LLC v. Greene’s Energy Group, LLC, et al.: 584 U.S. ___ 2018.

  9. Bultman M. Biologic fights drive PTAB drug challenges to record high. Law360. 2018. Accessed May 10 2018.

  10. Gifford CN. Boehringer Ingelheim Prevails in IPR Against AbbVie’s’ 135 Humira Patent. Rothwell Figg. 2017. Accessed 11 Oct 2018.

  11. Stanton D. AbbVie: Humira’s patent maze will keep US biosimilars away until at least 2022. Biopharma Reporter. 2015. Accessed 11 Oct 2018.

  12. Malkin BJ. Biosimilars patent litigation in the EU and the US: a comparative strategic overview. GABI J Generics Biosimilars Initiative J. 2015;4(3):113–7.

    Article  Google Scholar 

  13. Sohn J-Y. Samsung bioepis files lawsuit against AbbVie on Humira patents. Korea Herald. 2016 April 4.

  14. Staff Reporter. Settled lawsuit paves way for Humira biosimilar in EU from October. BioPharma Reporter. 2018. Accessed 11 Oct 2018.

  15. AbbVie, Amgen settlement sets Humira U.S. biosimilar launch for 2023. Reuters. 2017 September 28.

  16. Shapiro-Barr T, Heimbecher R. Biosimilars: Poised to Turn to Inter Partes Review to Resolve Patent Disputes. Metropolitan Corporate Counsel. 2015. Accessed 13 Jan 2018.

  17. Lund D. Members of Congress Express Concerns About Abuses of PTO’s Inter Partes Review System. Center for the Protection of Intellectual Property. 2016. Accessed 10 May 2018.

  18. United States Government Accountability Office. Intellectual Property: Patent Office Should Define Quality, Reassess Incentives, and Improve Clarity. 2016.

  19. Hirschler B, Shields M. Novartis launches first U.S. ‘biosimilar’ drug at 15 percent discount. Reuters. 2015. Accessed 11 Oct 2018.

  20. Davio K. Pfizer Launches Biosimilar Filgrastim, Nivestym, at a Substantial Discount. 2018. Accessed 11 Oct 2018.

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We thank Mark Joshua Gordon, Oliver Sartor, James Armitage, and Terhi Hermanson for their valuable feedback.

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Correspondence to Brian K. Chen.

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The author have no conflicts of interest to report. This article has not been submitted to any other publication.

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This article was supported in part by Grants from the American Cancer Society (IRG13-043-01), the National Institute of Health (R01CA165609), the University of South Carolina and the Centers for Economic Excellence program of the state of South Carolina (11150-13-32600), and philanthropic gifts from Doris Levkoff Meddin and Frank P. and Josie M. Fletcher to the Smart State Center for Medication Safety.

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Chen, B.K., Yang, Y.T. & Bennett, C.L. Why Biologics and Biosimilars Remain So Expensive: Despite Two Wins for Biosimilars, the Supreme Court’s Recent Rulings do not Solve Fundamental Barriers to Competition. Drugs 78, 1777–1781 (2018).

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