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.
We thank Mark Joshua Gordon, Oliver Sartor, James Armitage, and Terhi Hermanson for their valuable feedback.
Compliance with ethical standards
Conflict of interest
The author have no conflicts of interest to report. This article has not been submitted to any other publication.
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.
- 7.Sandoz Inc. v. Amgen Inc. 582 U.S. ___ 2017.Google Scholar
- 8.Oil States Energy Services, LLC v. Greene’s Energy Group, LLC, et al.: 584 U.S. ___ 2018.Google Scholar
- 9.Bultman M. Biologic fights drive PTAB drug challenges to record high. Law360. 2018. https://www.law360.com/articles/1010653/biologic-fights-drive-ptab-drug-challenges-to-record-high. Accessed May 10 2018.
- 10.Gifford CN. Boehringer Ingelheim Prevails in IPR Against AbbVie’s’ 135 Humira Patent. Rothwell Figg. 2017. http://www.biosimilarsip.com/2017/07/17/boehringer-ingelheim-prevails-ipr-abbvies-135-humira-patent/. Accessed 11 Oct 2018.
- 11.Stanton D. AbbVie: Humira’s patent maze will keep US biosimilars away until at least 2022. Biopharma Reporter. 2015. https://www.biopharma-reporter.com/Article/2015/11/03/AbbVie-Humira-s-patent-maze-to-keep-US-biosimilars-at-bay-until-2022. Accessed 11 Oct 2018.
- 13.Sohn J-Y. Samsung bioepis files lawsuit against AbbVie on Humira patents. Korea Herald. 2016 April 4.Google Scholar
- 14.Staff Reporter. Settled lawsuit paves way for Humira biosimilar in EU from October. BioPharma Reporter. 2018. https://www.biopharma-reporter.com/Article/2018/04/06/Settled-lawsuit-paves-way-for-Humira-biosimilar-in-EU-from-October. Accessed 11 Oct 2018.
- 15.AbbVie, Amgen settlement sets Humira U.S. biosimilar launch for 2023. Reuters. 2017 September 28.Google Scholar
- 16.Shapiro-Barr T, Heimbecher R. Biosimilars: Poised to Turn to Inter Partes Review to Resolve Patent Disputes. Metropolitan Corporate Counsel. 2015. http://www.metrocorpcounsel.com/articles/32490/biosimilars-poised-turn-inter-partes-review-resolve-patent-disputes. 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. https://cpip.gmu.edu/2016/12/09/members-of-congress-express-concerns-about-abuses-of-ptos-inter-partes-review-system/. Accessed 10 May 2018.
- 18.United States Government Accountability Office. Intellectual Property: Patent Office Should Define Quality, Reassess Incentives, and Improve Clarity. 2016.Google Scholar
- 19.Hirschler B, Shields M. Novartis launches first U.S. ‘biosimilar’ drug at 15 percent discount. Reuters. 2015. https://www.reuters.com/article/us-novartis-drug-idUSKCN0R30C220150903. Accessed 11 Oct 2018.
- 20.Davio K. Pfizer Launches Biosimilar Filgrastim, Nivestym, at a Substantial Discount. 2018. https://www.centerforbiosimilars.com/news/pfizer-launches-biosimilar-filgrastim-nivestym-at-a-substantial-discount. Accessed 11 Oct 2018.