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 other instances, AbbVie injected formulation patents into the dance, even though it was clear that the biosimilars formulation did not infringe them. Not just arthritis, but Crohn's Disease, ulcerative colitis and even the heartbreak of psoriasis are treated with it. The implementation of the tender relies on a well-established system of guidelines for specific therapeutic areas. Front. 170 at 18). FIGURE 2. 8, 288. doi:10.3389/fphar.2017.00288, Kim, Y., Kwon, H.-Y., Godman, B., Moorkens, E., Simoens, S., and Bae, S. (2020). EM and RE provided data on Iceland and critically revised the manuscript. Pharmacol. Generics Biosimilars Initiative J. Originally, originator adalimumab was listed in the Dark Yellow Box, meaning it could only be reimbursed after prior approval by the chief medical officer of the respective health insurance fund (Godman et al., 2009). (2017). Front. However, Albania, Belgium and Finland had substantial decreases in list price (Figure 1). Dis. A multi-winner tender for adalimumab was chosen to ensure sustainability of the market (sales are generated for companies and shortages are prevented). Regardless of the disease severity, corticosteroids are used to treat CD patients because they are effective in inducing disease remission. Open Pharmacoecon. (2019). Last year alone, it made over 15B in sales worldwide. Italy 21 (1), doi:10.7175/fe.v21i1.1449, Putrik, P., Ramiro, S., Kvien, T. K., Sokka, T., Pavlova, M., Uhlig, T., et al. 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. Front. Figure 1 visualizes these actual prices and shows that countries that still have relatively high list prices after loss of exclusivity often have relatively low actual prices (e.g., Italy, Norway, Denmark, Netherlands). ArV and BG developed the idea for this study and were involved in the construction of the questionnaire and critically revised the manuscript. (2019). Pharmacol. When does a pile of sand become a heap? 22 (8), 722727. The case is currently pending within the Northern District of Illinois (In Re: Humira (Adalimumab) Antitrust Litigation, No. Weikersheim: La Merie Publishing, Malmstrom, R. E., Godman, B. 2019;10:279. doi:10.3389/fphar.2019.00279, PubMed Abstract | CrossRef Full Text | Google Scholar, Davio, K. (2018). Health 16 (1), 64. doi:10.1186/s12992-020-00590-3, Jakovljevic, M. B., Djordjevic, N., Jurisevic, M., and Jankovic, S. (2015). If the brand and generic can settle to avoid antitrust liability, then they will always do that. With Boehringer settlement, AbbVie completes Humira sweep: BioPharma dive. GA provided data on Cyprus and critically revised the manuscript. BG was also involved in data collection. Alerts are available for users with active subscriptions. J. Med. By using this Site you agree to the following, By using this Site you agree to the following. In most countries, additional (confidential) discounts and/or rebates existed before loss of exclusivity. Different policy measures and practices between Swedish counties influence market dynamics: Part 1-biosimilar and originator infliximab in the hospital setting. Its sales fell to $19 billion in 2019, giving the slightest taste of what things will look like after 2023 when Humira will be totally off-patent and its revenues will subsequently collapse. DrugPatentWatch employs three methods to identify biologic patents: These patents were identified from disclosures by the brand-side company, in response to 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. Inequities in access to biologic and synthetic DMARDs across 46 European countries. A bench trial is scheduled to begin in early November 2019. 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. In Austria, information on subsequent price reductions of originator adalimumab and entry of new adalimumab biosimilars (with successive price reductions) was also disseminated regularly, including price comparisons and market dynamics in the wider TNF- inhibitor class. Humira patent expiration. For instance, in some of the patent dances, which were a BPCIA statutory prelude to those litigations, AbbVie wielded scores of patents without responding to concerns from the biosimilars or elaborating on why they should be in the case. Vogler, S., Zimmerman, N., Leopold, C., Habl, C., and Mazag, J. Susannah Luthi. We are aware that expenditure on healthcare has been rising steadily among middle-income countries including the BRICS (Brazil, Russia India, China and South Africa), with growth rates exceeding those among high income countries in recent years (Jakovljevic, 2016; Jakovljevic and Getzen, 2016; Jakovljevic et al., 2020), with a similar difference seen between CEE and Western European countries (Jakovljevic et al., 2016). 4 injections (40mg 8ml) was given. TN was employed by ZEM Solutions at the time of the study. This thicket was insurmountable for biosimilars needing to litigate their way through it towards freedom to operate for biosimilar versions. Results: In May 2019, adalimumab biosimilars were available in 24 of the 30 countries surveyed. Grand View ResearchAvailable at: https://www.grandviewresearch.com/industry-analysis/tumor-necrosis-factor-tnf-inhibitor-drugs-market, Holman, C. M. (2017). 1 (2), 5868. Inflammatory bowel disease refers to chronic autoimmune diseases CD and ulcerative colitis, which cause intestinal inflammation. To address this uncertainty, biosimilar developers started several patent litigation cases against AbbVie for these secondary patents. It was noticed that the regions of North Glasgow and Clyde, which already had additional staffing for rheumatology for the etanercept switch, were able to quickly switch to the selected adalimumab biosimilar with high switching rates (near 100%). Please enter a work/business email address. These patents were identified from searching drug labels and other general disclosures from the brand-side company. Health Pol. 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 . However, based on key opinion leader insights, GlobalData forecasts risankizumab sales across the 7MM to fall closely behind Stelara, generating sales ofmore than$1bn by 2026. By clicking the Download Free Report button, you accept the terms and conditions and acknowledge that your data will be used as described in the GlobalData privacy policy Green Box assignment, following agreed price reductions. originator adalimumab and, when reported, also for biosimilars. However, a more general policy framework for biosimilars might have already been implemented. Findings from across Europe and their implications. 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. 12 (4), 439441. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). 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. Pharmacoeconomics Outcomes Res. In-house legal departments at branded pharmaceutical companies for both biologic drugs, as well as small-molecule drugs, will be taking note. For those on the consumer-side of drug prices, some elements of the district courts reasoning may be a bit difficult to swallow. There is no warranty that the data contained herein is error free. As there was no improvement. To leverage competition following entry of biosimilar adalimumab, only a few countries adopted measures specifically for adalimumab in addition to general policies regarding biosimilars. Mark. AbbVie is developing IL-23 inhibitorrisankizumab, which GlobalData forecasts to launch in the CD market as early as 2021 in the US and EU. See patent lawsuits and PTAB cases for adalimumab, LOE / Generic Entry Opportunies 2022 - 2023, ClinicalTrialExchange - Connecting volunteers and trials, Brand-side disclosures in response to biosimilar applications, Analyze global market entry opportunities, Obtain formulation and manufacturing information. It concluded that supply-side policies were in place in most of the countries surveyed, but that more could be done to communicate on biosimilars and educate stakeholders, especially physicians (Moorkens et al., 2017). 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). The editor and reviewer's affiliations are the latest provided on their Loop research profiles and may not reflect their situation at the time of review. (2010). Resour. When reported, discounts/rebates on originator adalimumab after loss of exclusivity ranged from 0% to approximately 26% (Romania), 60% (Poland), 80% (Denmark, Italy, Norway), and 8090% (Netherlands), leading to actual prices per pen or syringe between 412 (Finland) and 50 99 (Netherlands). Funding innovation thanks to anti-TNF- biosimilars uptake. Countries are sorted from high to low relative list price reduction (51% in Austria to 0% in several countries). 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. Malta reported that via tendering and negotiation it is possible to take advantage of competition. It is possible that the senior-level co-authors might not always know about the various measures and initiatives, especially local practices. However, competitive pricing keeps the market shares of originator adalimumab high (personal communication). However, Humira is set to face competition from biosimilars in the near future, with approvals from the European Commission (EC)and US Food and Drug Administration (FDA) for Amgens adalimumab biosimilar Amjevita in March 2017 and September 2016, respectively. Despite this, the court found that because all of the Humira patent cases eventually settled, that forecloses a finding that they were objectively baseless. Before nearly any of these cases moved past the preliminary stages, the biosimilars all fell in line and settled for entry dates in 2023. 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. 5, 219. doi:10.3389/fphar.2014.00219, Moorkens, E., Jonker-Exler, C., Huys, I., Declerck, P., Simoens, S., and Vulto, A. G. (2016). B., Diogene, E., Baumgartel, C., Bennie, M., Bishop, I., et al. Available at: https://fortune.com/longform/abbvie-humira-drug-costs-innovation/, NHS (2016). For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. But unlike most of its . More information on co-payment for adalimumab products in each of the countries surveyed can be found in the Supporting Material. AbbVie grew Humira into the world's bestselling medicine in part through price hikes and an ag Belg. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. Pharmacoecon. We disclaim all responsibility for the professional qualifications and licensing of, and services provided by, any physician or other health providers posting on or otherwise referred to on this Site and/or any Third Party Site. doi:10.1007/s40273-017-0559-4, Godman, B., Burkhardt, T., Bucsics, A., Wettermark, B., and Wieninger, P. (2009). Cost Eff. GaBI J. Countries with no adalimumab biosimilars on the market at that time were Cyprus, Greece, Kosovo, Malta, Serbia and the Republic of Srpska; with Greece at the time waiting for approval of reimbursement (eventually received in July 2020). EM was involved in construction of the questionnaire, data collection and validation, and drafted the initial version of the manuscript. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. 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. 2006-09-13. IM provided data on Romania and critically revised the manuscript. Sometimes a strategy was implemented even before loss of exclusivity, for example in Denmark and Scotland. This dual approach is important to help address discounting tactics by originator companies just before or soon after patent expiry to dissuade biosimilar manufacturers from entry. Completed surveys were obtained from 30 countries, 23 EU Member States, plus Albania, Iceland (member of the European Economic Area (EEA)), Norway (member of the EEA), Russia, Serbia, the Republic of Kosovo, and the Republic of Srpska (entity in Bosnia and Herzegovina). GlobalData (2017). As an example, one patent application formed the basis for twenty-two derivative continuation patents. AbbVie. According to AbbVie, there is no law proscribing how many patents are too many, and the plaintiffs cannot point to any law, rule or regulation that AbbVie purportedly violated in the course of lawfully procuring patents from the Patent Office, asserting them against the biosimilars and reaching the settlements that it did. As launch dates differ between countries, choosing a fixed point in time for each country (October 2018) enhances comparability of the results. doi:10.1371/journal.pone.0190147, Mukherjee, S. (2019). Available at: https://news.abbvie.com/news/abbvie-announces-global-resolution-humira-adalimumab-patent-disputes-with-sandoz.htm, AbbVie (2019). The expiration dates listed for these patents are estimates, based on the grant date of the patent. Indeed, that finding by the court may alone create a clear exit plan for any branded pharmaceutical company to avoid antitrust liability for misusing an enormous heap of patents (unless those patents were procured by fraud.) First, who are the plaintiffs and what are their allegations? Pharmacol. PloS One 13 (5), e0196106. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2022, www.DrugPatentWatch.com. Conclusion: Even though originator adalimumab is the highest selling product in the world, few countries have implemented specific policies and practices for (biosimilar) adalimumab. Out of that $15.4 billion, only $2.6 billion was international sales, with $12.8 billion coming from the US market alone. (2020). Pharmacoeconomics Outcomes Res. Earlier papers have also suggested a focus on demand-side policies, such as specific stakeholder incentives, guidelines and education, rather than solely targeting price is important to enhance their use and attain target savings (Moorkens et al., 2017; Rmuzat et al., 2017b). Ann. The plaintiffs allegations do not appear to be just that AbbVie accumulated lots of patents, but rather that AbbVie used that unwieldy heap of patents, regardless of their merits, to force the biosimilars to avoid litigation all together. Biotechnol. AbbVies success rate with its patent applications was 53.4%, or more than half. 7, 18. doi:10.3389/fphar.2016.00018, Jakovljevic, M., Potapchik, E., Popovich, L., Barik, D., and Getzen, T. E. (2017). (2019). Countries with available and reimbursed biosimilars on the market seem to have price regulation and/or competition leading to lowered list or actual prices. TN provided data on Serbia and critically revised the manuscript. Background: From October 2018, adalimumab biosimilars could enter the European market. Outcomes Res. Some countries already provided prices in euro, but have a different currency (Albania, Croatia, Serbia, Republic of Srpska, Russia). Competitors are already taking advantage of it. <http://biopharmapatent.blogspot.com/2017/01/abbvie-humiras-patent-maze-will-keep-us.html>. In addition to list prices and actual prices shown in Table 4, claw-backs might also play a role in further lowering prices; for example in Belgium, where sales of biosimilars and low-priced biologicals (i.e., biological products decreased to the price level of the biosimilar) were at the time of the study included when calculating claw-back taxes. AGV is involved in consulting, advisory work and speaking engagements for a number of companies, a.o. The plaintiffs are indirect purchasers of Humira. J. (2015). Antibodies 25 (12), 116. 73 (1), 198206. Front. Although this information is not easily elucidated, we at least partly succeeded. J. 9, 467472. Fierce Pharma AsiaBeiGene's BTK win; Bayer, Hua's diabetes nod; Novavax, Fujifilm's ill-fated COVID deal. In addition, the link between the development of adalimumab biosimilar market shares in different countries and actual price differences between originator and biosimilar products or other policy measures could be further investigated to help understand originator/biosimilar market dynamics, as was previously studied for infliximab and etanercept in the Swedish context (Moorkens et al., 2019a; Moorkens et al., 2019b). J. (2019). Pharmacoeconomics 35 (12), 12711285. 9 (5), 475484. IM is involved in consulting and advisory work and recently worked with I&S Hungary, Ewopharma, Genesis Pharma, GSK. Application filed by AbbVie Inc. 2016-02-11. Sport Health Sci. In addition, companies marketing biosimilars are playing the pricing game, since country representatives often reported that, even with large discounts/rebates for originator adalimumab, the biosimilar is the least expensive product to use (e.g., Denmark, Italy, Poland, Romania, and some hospitals in the Netherlands). (2017b). AbbVies Humira (adalimumab) is considered a first-line biologic therapy in the treatment of moderate-to-severe Crohns disease (CD). Secondly, the availability of biosimilars, the reimbursement status of originator adalimumab, listed and reimbursed prices, and potential discounts, before and after loss of exclusivity (up to May 10, 2019), were requested. Background: From October 2018, adalimumab biosimilars could enter the European market. Policies to enhance prescribing efficiency in Europe: findings and future implications. Front. (Vogler et al., 2019) on price developments for several molecules, including adalimumab, has shown that the average cost per milligram of a molecule decreased after the entry of the biosimilar in 15 European countries. Comparative financing analysis and political economy of noncommunicable diseases. Lancet Oncol. Can using too many patents to compel generics to take a later entry date turn into monopolistic conduct? However, reimbursement does not always equal actual patient access to treatment, especially in some CEE countries (Kawalec et al., 2017). Farmeconomia Health Econ. Amyloid plaque inhibition #1 target for Alzheimers pipeline, but is it off-target? J. In addition to specific supply-side policy measures related to pricing and reimbursement that were discussed earlier, demand-side policy measures and practices might also influence originator/biosimilar market dynamics. Several patent litigation cases against AbbVie for these patents are estimates, based the! 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