This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The survey was written in English and included both open- and closed-ended questions. Glob. Progress is monitored to switch patients to the biosimilar at their next prescription with the patients agreement, and has been similar or better than previous switches, confirming the validity of the process. doi:10.1016/S1470-2045(15)00381-2, Sagonowsky, E. (2017). Alloc. Institute of Comparative Economic Studies, Hosei University, Japan. Dis. PloS One 13 (5), e0196106. Implications of global pricing policies on access to innovative drugs: the case of trastuzumab in seven latin american countries. Humira is a biologic drug originally approved in 2002. The role of discounts and loss leaders in medicine procurement in Austrian hospitals a primary survey of official and actual medicine prices. Boehringer can begin selling its copycat of the world's best-selling drug on July 1, 2023, paying royalties to AbbVie for the U.S. license, according to the settlement. Policies for biosimilar uptake in Europe: an overview. The civil litigation infrastructure is incapable of litigating all of those patents, and just having them, no matter their merit, will act as a bulwark against generic competition. Vogler, S., Zimmermann, N., Habl, C., and Mazag, J. In May 2019, biosimilars for adalimumab were available in 24 of the 30 countries surveyed (Table 2). The plaintiffs are indirect purchasers of Humira. Biosimilars in Belgium: a proposal for a more competitive market. However, in some countries, such as Netherlands, high discounts reported for the originator product may have influenced biosimilar entry. doi:10.1080/13696998.2019.1600523, Jakovljevic, M., Lazarevic, M., Milovanovic, O., and Kanjevac, T. (2016). 2019;10:279. doi:10.3389/fphar.2019.00279, PubMed Abstract | CrossRef Full Text | Google Scholar, Davio, K. (2018). Pharmacol. A weekly roundup of the latest news and analysis, sent every Friday. ArV and BG developed the idea for this study and were involved in the construction of the questionnaire and critically revised the manuscript. FIGURE 1. TN was employed by ZEM Solutions at the time of the study. In Ireland, the introduction of the Best value biological policy has resulted in recommendations for biosimilar adalimumab (with or without citric acid) and biosimilar etanercept to be prescribed as first line treatments when TNF- inhibitors are warranted, as well as helping with switching (HSE Ireland - Clinical Stratgey and Programmes Division, 2019a; HSE Ireland - Clinical Stratgey and Programmes Division, 2019b). Common Questions and Answers about Humira patent expiration. Front. (2019). <http://biopharmapatent.blogspot.com/2017/01/abbvie-humiras-patent-maze-will-keep-us.html>. Health Econ. Funding innovation thanks to anti-TNF- biosimilars uptake. Never disregard the medical advice of your physician or health professional, or delay in seeking such advice, because of something you read on this Site. MMP roadmap for the prescribing of best-value biological (BVB) medicines in the Irish healthcare setting. In Germany and Austria, health insurance funds use rebate contracts and non-binding recommendations. Background: From October 2018, adalimumab biosimilars could enter the European market. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. *Correspondence: Arnold G. Vulto, a.vulto@gmail.com, a.vulto@erasmusmc.nl, HSE Ireland - Clinical Stratgey and Programmes Division, https://doi.org/10.3389/fphar.2020.591134, HSE Ireland - Clinical Stratgey and Programmes Division, 2019a, HSE Ireland - Clinical Stratgey and Programmes Division, 2019b, https://www.frontiersin.org/articles/10.3389/fphar.2020.591134/full#supplementary-material, https://news.abbvie.com/news/abbvie-announces-global-resolution-humira-adalimumab-patent-disputes-with-sandoz.htm, https://news.abbvie.com/news/press-releases/abbvie-resolves-humira-adalimumab-us-patent-litigation-with-boehringer-ingelheim.htm, https://news.abbvie.com/news/abbvie-reports-full-year-and-fourth-quarter-2018-financial-results.htm, https://amgros.dk/en/knowledge-and-analyses/articles/new-international-record-for-switch-to-biosimilar/, https://www.centerforbiosimilars.com/news/after-biosimilar-deals-uk-spending-on-adalimumab-will-drop-by-75, https://www.biopharmadive.com/news/abbvie-boehringer-ingelheim-settle-humira-patent-biosimilar/554729/, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf, https://www.ema.europa.eu/en/medicines/download-medicine-data, https://www.grandviewresearch.com/industry-analysis/tumor-necrosis-factor-tnf-inhibitor-drugs-market, https://www.hse.ie/eng/about/who/cspd/ncps/medicines-management/best-value-biological-medicines/, https://www.hse.ie/eng/about/who/cspd/ncps/medicines-management/best-value-biological-medicines/mmp-roadmap-for-the-prescribing-of-best-value-biological-bvb-medicines-in-the-irish-healthcare-setting.pdf, https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/the-global-use-of-medicine-in-2019-and-outlook-to-2023.pdf, https://fortune.com/longform/abbvie-humira-drug-costs-innovation/, http://www.healthcareimprovementscotland.org/our_work/technologies_and_medicines/adtc_resources/biosimilar_meds_case_studies.aspx, https://www.fiercepharma.com/pharma/boehringer-deal-abbvie-s-megablockbuster-u-s-market-for-humira-looks-safe-until-2023. In Estonia, a change in setting from hospital only to both ambulatory care and hospital setting was introduced following the entry of adalimumab biosimilars. doi:10.1017/S0266462315000094, Piperska Group Rational prescribing: piperska group. Price negotiations with AbbVie eventually led to the same arrangement for originator adalimumab, i.e. List price reductions of originator adalimumab on May 10 2019 versus list prices before loss of exclusivity (October 2018 or earlier) for all countries surveyed where list prices before and after loss of exclusivity of originator adalimumab were reported. Five-year survival and costs of care in metastatic colorectal cancer: conventional versus monoclonal antibody-based treatment protocols. Pharmacol. Expert Rev. Sport Health Sci. In Ireland, the implementation of a best value biological policy, resulted in a strong recommendation to use the best value biologicals Imraldi (biosimilar adalimumab) or Benepali (biosimilar etanercept) when initiating treatment and issuing a repeat prescription. We have used this approach before when analyzing the influence of different initiatives and pricing policies to provide robust information (Godman et al., 2010;Baumgrtel et al., 2012; Godman et al., 2013; Godman et al., 2014a; Godman et al., 2014b; Moon et al., 2014; Ferrario et al., 2017; Moorkens et al., 2017; Godman et al., 2019). 19 (3), 251261. AbbVies Humira (adalimumab) is considered a first-line biologic therapy in the treatment of moderate-to-severe Crohns disease (CD). This paper reflects some of these changes. GaBI J. Mandatory price decreases, a policy measure often seen in the retail setting and for example occurring in Austria, Belgium and Ireland, might be effective in short-term cost containment, but are probably a factor hindering competition by limiting price differences and thus incentives to switch. Countries are sorted from high to low relative list price reduction (51% in Austria to 0% in several countries). Given this, the Humira puchasers lawsuit alleged that AbbVie created a veritable thicket of patents. 12 (4), 439441. Front. Because of that, AbbVie never actually prevailed on its patent infringement allegations, and therefore, the court could not definitely say that AbbVies assertion of its patents was not objectively baseless. Green Box assignment, following agreed price reductions. 9, 467472. Biotechnol. In most countries, additional (confidential) discounts and/or rebates existed before loss of exclusivity. (2014a). Given that the biosimilars themselves were named in this litigation, they would also have an incentive to reach settlements as often as possible. A recent analysis by Vogler et al. GS provided data on Germany and critically revised the manuscript. Front. In Romania, co-payment for originator adalimumab is covered via a Patient Access Scheme, but in order to receive a co-payment waiver, patients need to go through an administrative process every 3months. Other countries did not report specific measures targeting adalimumab, but more general measures regarding biosimilars might also affect the use of adalimumab biosimilars. The competition does sell versions of it (Remicade and Humira) but those are just as costly. Serving leading biopharmaceutical companies globally: Identify potential brand extensions & biosimilar entrants, Identify key patents and potential future biosimilar entrants. Additionally, this study adds to the scarce literature on policy measures affecting biosimilar/originator market dynamics (Renwick et al., 2016; Moorkens et al., 2017; Rmuzat et al., 2017a; Rmuzat et al., 2017b; Moorkens et al., 2019a; Moorkens et al., 2019b). The survey responses were analyzed descriptively, with open-ended questions examined in a qualitative way. Prices in different currencies were converted to euros with the exchange rate of December 19, 2019 for Bulgaria, the Czech Republic, Denmark, Iceland, Norway, Poland, Romania, Scotland, and Sweden. Some examples of countries with guidelines on economic prescribing include Greece, Belgium, and Germany. Front. The overview of prices, reimbursement status and policy measures for originator adalimumab and biosimilars was obtained using a survey distributed via email amongst members of the Piperska Group. CD occurs most commonly in the lower part of the small intestine and in the large intestine, although the location and severity of the disease differs by individual. In the case of Humira, AbbVie extended its monopoly from December 2016 until 2023, to the tune of billions of dollars. Appl. Finally, respondents were asked to elaborate on health authority/health insurance company measures related to the use of adalimumab in their country, especially measures affecting the utilization of biosimilars since the perspective of this paper is that of health authorities. 11, 970. doi:10.3389/fphar.2020.00970, Kovacevic, A., Dragojevic-Simic, V., Tarabar, D., Rancic, N., Jacimovic, N., Katic, J., et al. 7, 193. doi:10.3389/fphar.2016.00193, Moorkens, E., Simoens, S., Troein, P., Declerck, P., Vulto, A. G., and Huys, I. This post focuses exclusively on the 2 claim, namely, that AbbVies use of its patent thicket was unlawful.). Pharmacoeconomics 35 (12), 12711285. Future research could focus on achieving more insight into discounts and rebates in the off-patent market by, for example, carrying out anonymous surveys/interviews; a methodology that was employed previously in studies by Vogler and colleagues (Vogler et al., 2013). Overall, list prices of originator adalimumab decreased after loss of exclusivity, although for 13 countries list prices were unchanged. This can be dependent on the level of tendering (national, regional, hospital) and guidelines to implement a potential switch and ensure sufficient market share. Yet, antitrust laws are not only for the protection of competitors, but also consumers. Publication of US20160039927A1. Alongside this, internal reference pricing and decreasing the reference price to the level of the lower-priced biosimilar, which is used in the Czech Republic, Latvia and Romania, does not always provide an incentive to use the biosimilar, as patient co-payments for the more expensive originator product can be lowered after confidential price reductions offered by the marketing authorization holder. Large variations can be seen in the efforts of countries to leverage competition from biosimilars and implement policy measures related to the use of (biosimilar) adalimumab, see Table 5. Kris Tripplaar/Sipa USA. Estimated Patent Expiration Source; Abbvie Inc. HUMIRA: adalimumab: Injection: 125057: See Plans and Pricing: 2034-06-16: Patent claims search: Abbvie Inc. HUMIRA: adalimumab: Injection: 125057: See Plans and Pricing: 2032-12-21: Patent claims search: Abbvie Inc. HUMIRA: adalimumab: Injection: 125057: See Plans and Pricing: 2033-03-11: Patent claims search: Abbvie Inc. HUMIRA: adalimumab Discounts were not always available on a national level for some countries and can pertain to a single region or hospital group, e.g., the Veneto region in Italy, and hospital groups in the Netherlands. Evolving health expenditure landscape of the BRICS nations and projections to 2025. Farmeconomia Health Econ. Matching patents to biologic drugs is far more complicated than for small-molecule drugs. ), (The foregoing allegations made in the lawsuit are under 2 of the Sherman Act. RP was employed by HTA Consulting at the time of the study. AbbVie. Supply-side and demand-side policies for biosimilars: an overview in 10 European member states. By Ryan Knox and Gregory Curfman Since receiving FDA approval for Humira (adalimumab) in 2002, AbbVie, the drug's manufacturer, has filed hundreds of submissions to the U.S. Patent and Trademark Office for secondary patents - almost half of which were filed after 2014, just two years before the expiration of its core patent. TABLE 4. 19 (1), 7076. AbbVies response to the lawsuit, set forth in its motion to dismiss, included many of the expected arguments. Assess. EM and RE provided data on Iceland and critically revised the manuscript. One or more senior-level health authority personnel or their advisers were approached in each country for their help. AJ provided data on Kosovo and critically revised the manuscript. Actual prices in these countries differed by a factor of 4.2. J. Oncology monoclonal antibodies expenditure trends and reimbursement projections in the emerging Balkan market. Exp. 5, 109. doi:10.3389/fphar.2014.00109, Godman, B., Paterson, K., Malmstrom, R. E., Selke, G., Fagot, J. P., and Mrak, J. In-house legal departments at branded pharmaceutical companies for both biologic drugs, as well as small-molecule drugs, will be taking note. We previously blogged about related allegations before the case was filed when Boehringer Ingelheim raised them within its biosimilar litigation against AbbVie. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2022, www.DrugPatentWatch.com. For those on the consumer-side of drug prices, some elements of the district courts reasoning may be a bit difficult to swallow. RP runs a consulting company and previously worked with, a.o., Abbvie, Biogen, Sandoz, Pfizer, MSD, Roche, GSK, Sanofi. Humira's patent expiration would be a seriously detrimental event if it was accompanied by the typical loss of revenue that has befallen so many former blockbusters. doi:10.1371/journal.pone.0196106, Kawalec, P., Stawowczyk, E., Tesar, T., Skoupa, J., Turcu-Stiolica, A., Dimitrova, M., et al. 11:591134. doi: 10.3389/fphar.2020.591134. They have a high certainty of blocking biosimilar entry. the good, the bad, and the ugly ways. DM provided data on Russia and critically revised the manuscript. However, Albania, Belgium and Finland had substantial decreases in list price (Figure 1). LV and VP provided data on Croatia and critically revised the manuscript. Available at: https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/the-global-use-of-medicine-in-2019-and-outlook-to-2023.pdf, Jakovljevic, M. M. (2016). Immunomodulators and aminosalicylates are used as first-line maintenance therapies in patients with CD of milder severity, while anti-TNF biologics such as Humira and Johnson & Johnsons (J&Js) Remicade (infliximab), Takedas anti-integrin biologic Entyvio (vedolizumab), and J&Js interleukin 12/23 (IL-12/23) inhibitor Stelara (ustekinumab) are used in more severe patients. Dabigatran a case history demonstrating the need for comprehensive approaches to optimize the use of new drugs. 5, 219. doi:10.3389/fphar.2014.00219, Moorkens, E., Jonker-Exler, C., Huys, I., Declerck, P., Simoens, S., and Vulto, A. G. (2016). Generics Biosimilars Initiative J. An appreciation of actual prices or indicative discounts/rebates after loss of exclusivity was obtained for Albania, Belgium, Denmark, Estonia, Finland, Italy, Netherlands, Norway, Poland, Romania and the Republic of Srpska (11 out of the 30 countries surveyed). Doctor adviced to have Exemptia ( Adalimumab) injection. Health 16 (1), 64. doi:10.1186/s12992-020-00590-3, Jakovljevic, M. B., Djordjevic, N., Jurisevic, M., and Jankovic, S. (2015). It framed the plaintiffs theory as an allegation that AbbVie used its patents in a way to unlawfully foreclose competitionnamely, AbbVie allegedly gummed up progress for lower-cost biosimilar competition by obtaining and asserting swaths of invalid, unenforceable, or noninfringed patents without regard to the patents merits. (Dkt. HSE Ireland - Clinical Stratgey and Programmes Division (2019a). Front. Often biosimilars are listed at the same or a lower price than the originator product and may be the least expensive product to use according to actual prices. RP provided data on Poland and critically revised the manuscript. Discounts/rebates ranged from 0% (actual price same as list price) to approximately 26% (Romania), 60% (Poland), 80% (Denmark, Veneto region Italy, Norway), and 80%90% (hospitals in the Netherlands) of the list price. Malta reported that via tendering and negotiation it is possible to take advantage of competition. Eventually eight companies developing biosimilars reached a settlement agreement that consists of three parts: 1) the biosimilar companies will not enter the United States market before 2023, 2) biosimilars are allowed access to the EU market as of October 2018 without risk of litigation, and 3) an undisclosed royalty arrangement (Dunn, 2019; AbbVie, 2018; AbbVie, 2019). Yet, the consumers, who again have no seat at the table when these settlements are brokered, are left picking up the tab. Pricing and reimbursement of biosimilars in Central and Eastern European countries. After biosimilar deals, UK spending on adalimumab will drop by 75%. The more the better. Discounts and rebates granted for medicines for hospital use in five European countries. But even then, the district courts prescription may be the right oneif this is truly is a problem, as leaders at the FDA have suggested, then it may require a legislative fix, not a judicial one. Year of patent expiration for the last patent-protected variant of a drug has been considered for analysis.For example, if a drug is going off patent in the U.S. in 2022 and in Europe in 2023, it. For example, in Austria restrictions for prescribing of adalimumab have been lifted. AbbVie's Humira, a treatment for inflammatory disease and the world's best-selling drug, is no longer patent-protected in the EU. Any reliance on data provided herein is done solely at the discretion of the user. The Supplementary Material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/fphar.2020.591134/full#supplementary-material. The court acknowledged that the plaintiffs were asserting a novel theory of antitrust liability. Friedman, Yali. The district courts decision acknowledges as much. RP provided data on Scotland and critically revised the manuscript. North Chicago, Illinois, USA: AbbVie News Center, AbbVie IncAvailable at: https://news.abbvie.com/news/abbvie-reports-full-year-and-fourth-quarter-2018-financial-results.htm, Amgros (2019). AbbVie management is in an interesting predicament here - with the expiration of the Humira patent in 2023 and the flood of biosimilar competitors eroding both the revenues and high profitability . In Latvia, this economic incentive almost disappeared due to a confidential discount for originator adalimumab after which co-payment was lowered and is only minimal. Italy 21 (1), doi:10.7175/fe.v21i1.1449, Putrik, P., Ramiro, S., Kvien, T. K., Sokka, T., Pavlova, M., Uhlig, T., et al. There is no warranty that the data contained herein is error free. (2017). When is a portfolio of patents too many patents? Yet, those consumers nevertheless bare the brunt of paying increased monopoly costs over the years. The main limitation of this study is that primarily list prices were used in the analysis rather than actual prices, impeding a real comparison between countries. 17 (1), e31-8. In other instances, AbbVie injected formulation patents into the dance, even though it was clear that the biosimilars formulation did not infringe them. (2015). Given this, the Humira puchasers' lawsuit alleged that AbbVie created a veritable "thicket" of patents. For one Health Board (Greater Glasgow and Clyde), groups within gastroenterology, rheumatology and dermatology, dedicated to the efficient use of high-cost medicines, were tasked to come up with a strategy for biosimilar use. Changes in the utilization of venlafaxine after the introduction of generics in Sweden. Pharmacoecon. The last major legal standoff for a Humira biosimilar has ended, as AbbVie and Boehringer Ingelheim announced Tuesday a settlement of patent litigation over the U.S. entry date. Overall, list prices of originator adalimumab (40mg syringe or pen) decreased after loss of exclusivity rights in October 2018, and the entry of biosimilars to the market, from an average of 516 to 456 per unit (median of 430.11 per unit). Humira actually would cost me more. Competitors are already taking advantage of it. Copyright 2021 Moorkens, Godman, Huys, Hoxha, Malaj, Keuerleber, Stockinger, Mrtenhuber, Dimitrova, Tachkov, Vonina, Palevski, Achniotou, Slab, Popelkov, Kohoutov, Bartels, Laius, Martikainen, Selke, Kourafalos, Magnsson, Einarsdttir, Adams, Joppi, Allocati, Jakupi, Viksna, Greiit-Kuprijanov, Vella Bonanno, Suttorp, Melien, Plisko, Mardare, Meshkov, Novakovuc, Frst, Zara, Markovi-Pekovi, Grubia, Befrits, Puckett and Vulto. , 916. adalimumab patent expiration study reports list prices including value added tax and margins ( where appropriate. General policy framework for biosimilars needing to litigate their way through it towards freedom to operate for biosimilar versions granted! On Albania and critically revised the manuscript spending share in low and middle income countries solely. Applicant names are the property of their responses prior to submission Greece, Iceland and Romania least. Is also the case covers a novel legal theory, it is to! 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