As an example, one patent application formed the basis for twenty-two derivative continuation patents. Boehringer buckles in AbbVie patent fight, saving Humira from biosims until 2023. Pharmacol. Front. doi:10.1089/blr.2017.29000.cmh. Biosimilars in Belgium: a proposal for a more competitive market. Some examples of countries with guidelines on economic prescribing include Greece, Belgium, and Germany. For those on the consumer-side of drug prices, some elements of the district courts reasoning may be a bit difficult to swallow. It found that the biosimilar companies who settled with AbbVie, including Amgen, Samsung Bioepis and Sandoz, conceded that they had to enter into the settlement agreements because their only other choices were years of expensive litigation over an impassable patent thicket or an at-risk launch likely to result in a hefty damages award. (Dkt. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2022, www.DrugPatentWatch.com. Green Box assignment, following agreed price reductions. Furthermore, evolving volumes, market shares and policy measures could be studied together for the whole class of TNF- inhibitors. It seems that countries with biosimilars on the market have price competition leading to lowered list or actual prices. We chose to include price changes relative to the price before loss of exclusivity of Humira in October 2018. Cost Eff. In Lithuania, physicians are obliged by treatment guidelines, which are approved by order of the Ministry of Health, to prescribe new patients the least expensive TNF- inhibitor. Application filed by AbbVie Inc. 2016-02-11. How to solve financing gap to ensure patient access to patented pharmaceuticals in CEE countries? Hum. 7, 193. doi:10.3389/fphar.2016.00193, Moorkens, E., Simoens, S., Troein, P., Declerck, P., Vulto, A. G., and Huys, I. As launch dates differ between countries, choosing a fixed point in time for each country (October 2018) enhances comparability of the results. VS provided data on Netherlands and critically revised the manuscript. According to the district court, patents that are not acquired by fraud are presumed to be valid, and patent Examiners are presumed to be competently examining applications. List prices ranged from 233.65 per unit in Austria to 955.47 in Germany (factor 4.1 difference). In the Netherlands, some insurance companies support hospitals which have a less favourable biosimilar contract by giving a grant for the implementation of a biosimilar or providing higher reimbursement to the hospital, which would otherwise make a loss on dispensing biosimilars. The adalimumab biosimilar Idacio, which was given marketing authorization in April 2019, was only just launched in Germany (May 1, 2019). In Belgium, a pilot project (started in 2019) is testing a financial incentive that encourages physicians to prescribe a percentage of biosimilar adalimumab or etanercept in ambulatory care. doi:10.1016/j.jshs.2019.09.002, Jakovljevic, M., Timofeyev, Y., Ranabhat, C. L., Fernandes, P. O., Teixeira, J. P., Rancic, N., et al. The pharmaceutical industry's most comprehensive news and information delivered every month. Funding innovation thanks to anti-TNF- biosimilars uptake. humira. The Noerr-Pennington doctrine exempts instances of petitioning the government from antitrust liability, even if doing so has an anticompetitive effect. Resour. A biological medicines treatment cost comparator for TNF- inhibitors and competing biologicals was also developed nationally and shared with Health Boards, showing average treatment costs of different agents over a three-year time horizon. patent expired in Europe, Japan and Australia in 2012, and as an indicator to what is to come for Pfizer in the United States; between 2012 and 2015, Pfizer's annual revenue from Methods: Experts in European countries received a survey consisting of three parts: 1) general financing/co-payment of medicines, 2) reimbursement status and prices of originator adalimumab, and availability of biosimilars, and 3) policy measures related to the use of adalimumab. 170 at 17). Likewise, the court acknowledged that it is important to view the plaintiffs characterization of the alleged monopolization scheme as a whole. In Iceland, originator adalimumab is not recommended as a first-choice medicine to treat immunological conditions, since less expensive biosimilars are available, and is only reimbursed when the prescriber provides specific medical reasons. (2010). Pharmacol. However, reimbursement does not always equal actual patient access to treatment, especially in some CEE countries (Kawalec et al., 2017). Yusimry should be available in the U.S. after Humira's patent expires in July 2023. On October 16, 2018, product-specific patent protection on Humira (extended with a supplementary protection certificate and an additional 6months of pediatric exclusivity) came to an end in most European Union (EU) countries, 15years after the initial marketing authorization (Storz, 2017). Ithad estimated CD-specific sales of $1.9bn in 2016 across the seven major healthcare markets (7MM) ofthe US, France, Germany, Italy, Spain, the UK,and Japan. Whether or not that may be true, the industry-at-large is watching this suit. What are the takeaways from the case? In all of the countries surveyed, originator adalimumab is reimbursed (fully or partially, and sometimes with restrictions in use), except for Kosovo, where it is not marketed. (2019a). 170 at 31). Available at https://www.fiercepharma.com/pharma/boehringer-deal-abbvie-s-megablockbuster-u-s-market-for-humira-looks-safe-until-2023, Storz, U. Pharmacoecon. M provided data on Norway and critically revised the manuscript. The district courts decision acknowledges as much. Competitors are already taking advantage of it. This is particularly welcomed among CEE countries to help enhance the use of biologicals from a lower base compared to Western 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. 7, 18. doi:10.3389/fphar.2016.00018, Jakovljevic, M., Potapchik, E., Popovich, L., Barik, D., and Getzen, T. E. (2017). Data was collected between May and November 2019. Overview of reimbursement status and treatment setting of originator adalimumab (Humira) in the different European countries surveyed (May 2019). This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). Reimbursement was limited to certain criteria regarding disease group, failure of pre-treatments and prescription by specialized physicians. But this theory falls apart, according to the district court, because it involves petitioning the government. Available at: http://www.piperska.org/, Povero, M., and Pradelli, L. (2020). In Estonia, adalimumab had changed treatment setting (hospital to retail). Prescribing of the most cost-effective TNF- inhibitor, adalimumab, was requested. This group is a Pan-European network of health authority, health insurance company personnel and their advisers, as well as academics performing research on the rational use of medicines. The major learning from this research is that both originator and biosimilar companies adjust their strategy and pricing to each individual market, each with its own peculiarities. No use, distribution or reproduction is permitted which does not comply with these terms. First, who are the plaintiffs and what are their allegations? Information on financing of medicines in the different countries surveyed and levels of co-payment, gathered via part 1 of the survey, can be found in the Supporting Material. In addition, enhance the opportunity for greater access to effective biological medicines among Central and Eastern European (CEE) countries as well as other lower- and middle-income countries where access has been an issue due to high prices, sustainability of healthcare systems, and high co-payment levels (Mihajlo, 2014; Putrik et al., 2014; Jakovljevic et al., 2015; Kovacevic et al., 2015; Pichon-Riviere et al., 2015; Baumgart et al., 2019). (2017). 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. Humiras rise to the top of the anti-tumour necrosis factor (anti-TNF) class is partly due to its convenient administration as a subcutaneous injection, as well as AbbVies extensive marketing. Generics Biosimilars Initiative J. Grand View ResearchAvailable at: https://www.grandviewresearch.com/industry-analysis/tumor-necrosis-factor-tnf-inhibitor-drugs-market, Holman, C. M. (2017). 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 . With sales of US$20 billion in 2018, Humira is the highest selling product in the world and generates 60% of AbbVies revenue (AbbVie News Center, 2019). TABLE 1. Moreover, the resulting portfolio included numerous overlapping patentsfor example, dozens of formulation patents or process patents with only minor distinctions among them. doi:10.5639/gabij.2019.0802.007, Godman, B., Malmstrom, R. E., Diogene, E., Jayathissa, S., McTaggart, S., Cars, T., et al. In 15 of the countries surveyed, adalimumab can be dispensed in ambulatory care (retail pharmacy or similar setting), while in 14 countries its use is restricted to hospital use only (including day care/ambulant patients) (Table 3). Reported discounts varied widely between countries. PLoS One 12 (12), e0190147. For example, in Austria restrictions for prescribing of adalimumab have been lifted. The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. If AbbVies wall of patents truly worked to compel the biosimilars to agree to a 2023 entry date, despite the merits of the allegations, then the fact that AbbVie threw sharp elbows at its sophisticated competitors is cold comfort for consumers. 11, 970. doi:10.3389/fphar.2020.00970, Kovacevic, A., Dragojevic-Simic, V., Tarabar, D., Rancic, N., Jacimovic, N., Katic, J., et al. Exceptions included Albania, Austria, Finland, Greece, Iceland and Romania. Despite Humira patent expiry, Abbvie is poised to remain a market leader in Crohn's disease AbbVie's Humira (adalimumab) is considered a first-line biologic therapy in the treatment of moderate-to-severe Crohn's disease (CD). Pharmaceutical companies leverage the patent system to protect their investments in research and development. Protect at all costs: how the maker of the worlds bestselling drug keeps prices sky-high: fortune. (2019b). For Europe, from October 16, 2018 adalimumab biosimilars could potentially enter the market and offer countries, by increasing competition, new ways to reduce expenditures in immunological disease areas using TNF- inhibitors. Supply-side and demand-side policies for biosimilars: an overview in 10 European member states. J. DB provided data on Denmark and critically revised the manuscript. (2015). Comparison of historical medical spending patterns among the BRICS and G7. TN was employed by ZEM Solutions at the time of the study. Oct 14, 2022 09:05am. Disease-specific out-of-pocket and catastrophic health expenditure on hospitalization in India: do Indian households face distress health financing? Whilst the majority of data gathered via the survey was objective information regarding, for example, the availability of products and prices available in official databases, we also questioned (policy) measures related to the use of adalimumab. We previously blogged about related allegations before the case was filed when Boehringer Ingelheim raised them within its biosimilar litigation against AbbVie. A weekly roundup of the latest news and analysis, sent every Friday. The plaintiffs also alleged that AbbVies settlement agreements with the biosimilars, which gave permission to distribute in Europe, violated 1 of the Sherman Act. In Denmark, preparations included statements to physicians on switching, letters to patients and ensuring the presence of additional nurses to support switching. Humira is the trade name for adalimumab, (easy for you to say), that was initially approved for rheumatoid arthritis but has gone on to have indications in a variety of diseases. The competition does sell versions of it (Remicade and Humira) but those are just as costly. doi:10.1371/journal.pone.0196106, Kawalec, P., Stawowczyk, E., Tesar, T., Skoupa, J., Turcu-Stiolica, A., Dimitrova, M., et al. Impact of recent reforms in Austria on utilization and expenditure of PPIs and lipid-lowering drugs: implications for the future. Here, AbbVies allegedly anticompetitive conduct involved petitioning the government in multiple different ways. The reverse is the exception, and specific examples, based on actual prices, where originator adalimumab was the least expensive product to use, are Norway, the Stockholm region (Sweden), and some hospitals in the Netherlands. Available at: 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, Inotai, A., and Kalo, Z. (2014). ArV and BG developed the idea for this study and were involved in the construction of the questionnaire and critically revised the manuscript. An overview of patents on therapeutic monoclonal antibodies in Europe: are they a hurdle to biosimilar market entry? doi:10.1017/S0266462315000094, Piperska Group Rational prescribing: piperska group. doi:10.1080/17843286.2020.1761, Moorkens, E., Vulto, A. G., Huys, I., Dylst, P., Godman, B., Keuerleber, S., et al. 11 (4), 383393. But the court was still not convinced. 11:591134. doi: 10.3389/fphar.2020.591134. But unlike most of its . One or more senior-level health authority personnel or their advisers were approached in each country for their help. The authors would like to thank Michelle Derbyshire of MD Writing services for language editing and proofreading of the manuscript. Matching patents to biologic drugs is far more complicated than for small-molecule drugs.