The New Era of Inflammatory Disease Treatment: Anti-TNF Adalimumab Biosimilars

Author: Hannah J. Moir

Support statement: The writing and publication of this news feature was supported by Viatris, who were not involved in the creation of this content.

Anti-TNFs, also known as TNF inhibitors, actively suppress the action of TNF, a protein that plays a crucial role in inflammation. Currently, several anti-TNFs are available on the market, including adalimumab, certolizumab pegol, etanercept, golimumab, and infliximab. These anti-TNFs effectively treat a range of conditions in dermatology, gastroenterology, immunology, and rheumatology, encompassing ankylosing spondylitis, inflammatory bowel disease (IBD), psoriasis, psoriatic arthritis, and rheumatoid arthritis.

Nonetheless, anti-TNFs can prove to be expensive, thereby placing a financial burden on healthcare systems and, at times, limiting patient access. With biologic patents expiring, numerous biosimilar products have made their way into the healthcare market. Biosimilars are biological products that are highly similar to their reference products without clinically meaningful differences. Anti-TNF biosimilars offer a potential alternative that can facilitate earlier and more widespread access to appropriate therapies, alleviating the financial burdens associated with reference products.¹

GLOBAL MARKET DEVELOPMENTS FOR ADALIMUMAB BIOSIMILARS

This year marked the new dawn of the biosimilar industry, with the introduction of several adalimumab biosimilars in the USA market in July 2023.² This development is shaping the healthcare system and pricing strategies, with anticipation of how this is playing out, presenting greater opportunities for patient access, choices, and cost-savings. The immunology field is expected to grow due to the launch of these biosimilars, which have already made their mark in Europe. As such, there is movement in the pharmacoeconomic world of anti-TNF biosimilars, which is experiencing changes in response to these developments. The introduction of adalimumab biosimilars in the USA is expected to further influence this growth.²

In October 2023, there was market movement, with a substantial shift occurring in the marketing of interchangeable adalimumab biosimilars. These biosimilars were competitively priced, with significantly lower wholesale acquisition costs compared to the reference drug, which is approved for the treatment of various chronic inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis.^3,4 However, the effects on market share and substantial cost savings are yet to be observed.

Impact of Adalimumab Biosimilars on Global Healthcare Sustainability

At the forefront, these global market developments are also likely to impact the sustainability of global healthcare due to the rising demand and prevalence of autoimmune diseases and inflammatory conditions. This, coupled with the patent expiration of adalimumab in key markets and the increasing acceptance of biosimilars by patients, physicians, and payers, contributes to the ongoing discourse.

On the whole, the current global market for adalimumab biosimilars is marked by rapid growth, heightened competition, and diminishing prices. The utilisation of biosimilars has the potential to bring about a positive impact on healthcare sustainability, extending beyond cost-effectiveness.

Nonetheless, a recent publication by Alnaqbi et al.⁵ in August 2023, has identified how varying biosimilar policies can create disparities in market sustainability. To ensure the long-term sustainability of the biosimilar market, countries must establish sustainable biosimilar policies. The study evaluated countries across the Asia-Pacific region, Europe, North and South America, and the Gulf Cooperation Council nations. It was observed that countries with more experience in biosimilars, such as European countries, had more robust sustainability frameworks.⁵ However, it was recognised that all countries could benefit from biosimilar contracting approaches and further education on biosimilars. These policies should support industry sustainability and undergo regular updates to maintain long-term sustainability, with the ultimate aim of cultivating a globally sustainable biosimilar landscape and sharing best practices across international markets.⁵

ENHANCING PATIENT OUTCOMES THROUGH BIOSIMILAR INTERCHANGEABILITY

With the increasing presence of biosimilars in the market, competition is expected to further reduce prices, thus making adalimumab biosimilars even more cost-effective for both patients and payers. Biosimilars broaden access to treatment, aiming to improve patient outcomes and reduce the burden of disease. The significance of biosimilar cost reductions lies in the potential for earlier access to effective treatments, ultimately resulting in improved patient outcomes and a higher quality of life. A recent systematic review and meta-analysis, published in October 2023, found that patients who switched to a biosimilar maintained their efficacy and safety outcomes.⁶

According to guidelines from the European Alliance of Associations for Rheumatology (EULAR) and European Crohn’s and Colitis Organisation (ECCO), cost-effective drugs should be favoured over more expensive options, as long as their efficacy and safety profiles are comparable. The introduction of biosimilars has notably expanded access for patients to receive biologic therapy, including anti-TNF biosimilars, for rheumatoid arthritis and IBD.^1,7

Nevertheless, the Cardinal Health’s 2023 Biosimilars Report, focusing on the USA healthcare market of adalimumab biosimilars, identified that over 60% of healthcare providers expressed a preference for prescribing adalimumab biosimilars with interchangeability designations.⁸ This preference suggests the impact of the label on adoption, which could be attributed to safety concerns associated with switching. Interestingly, approximately 84% of providers reported being either “somewhat” or “very” comfortable with prescribing adalimumab biosimilars, with the highest level of comfort observed among gastroenterologists (93%).⁸ However, 64% of gastroenterologists and 62% of rheumatologists agreed or strongly agreed that they were only comfortable prescribing adalimumab biosimilars if they had an interchangeability designation.⁸

Regulatory agencies in Europe (The European Medicines Agency [EMA], the Heads of Medicines Agencies [HMA]), and the UK Medicines and Healthcare products Regulatory Agency [MHRA]) have updated their guidance to indicate that once authorised, a biosimilar product is considered interchangeable with their reference product. Additionally, several jurisdictions in Canada have implemented switching policies.

These recent shifts in the therapeutic landscape have led to an increase in strategic partnerships aimed at enhancing the supply and commercialisation of biosimilars. Interchangeable biosimilars are gaining prominence in regions like Australia, Europe, the USA, and the UK, as well as China, Japan, and South Korea. These developments are expected to intensify price competition, resulting in lower prices for adalimumab biosimilars. Ultimately, this will likely expand the accessibility of more affordable adalimumab treatment options for patients worldwide. The competition in this market is poised to have far-reaching implications.

Patient Perspective on Switching to Biosimilars

Transitioning patients from reference biologics to biosimilars has the potential for substantial cost savings; however, in the past, there has been some reluctance from healthcare professionals and patients. Emerging real-world evidence from registries, observational studies, and clinical practice also aligns with the findings of clinical trials, supporting the switch to biosimilars. Furthermore, ongoing real-world experience and patient education initiatives are pivotal in ensuring the successful switch to biosimilars. This wealth of data supports the effectiveness and safety of biosimilars in many indications, such as IBD, Crohn’s disease, and ulcerative colitis, and contributes to the increased acceptance by both healthcare professionals and patients, not only in initiating treatment with a biosimilar but also in switching from a reference product to a biosimilar.

Examining the real-world application of biosimilars, a recent observational study, PERFUSE (published in June 2023),⁹ delved into the experience of patients with IBD in France who received or switched to an adalimumab biosimilar. The study used a patient perception survey to determine the impact of these factors on treatment adherence and discontinuation. It also explored patients’ willingness to undergo training in biosimilar use. A total of 406 patients with IBD participated, including 62% who had never previously received a biologic therapy and 38% who had prior biologic exposure.⁹ The study highlighted that training was more frequently provided to patients new to biologics (87% versus 31% in those with prior biologic use).⁹ The findings underscore the necessity for comprehensive multidisciplinary patient education to enhance the patient experience and training in the administration of subcutaneous injections.⁹ Participants who attended training sessions expressed greater satisfaction with using the injection device. The research suggests that there is a perceived lack of support during switches, emphasising the importance of providing patients with appropriate information when starting new treatments, particularly during switching. Moreover, patient perception questionnaires may be a valuable tool for informing physician decisions and identifying patients at higher risk of non-adherence.

In terms of treatment adherence, a poster presentation at ECCO 2023 in March¹⁰ and another at EULAR 2023 in June,¹¹ indicated that patients who switched from another biologic were more likely to continue with the adalimumab biosimilar, in comparison to those who were new to biologics. This underscores the significance of patient education in supporting adherence and continuation with adalimumab biosimilars.

Adalimumab biosimilars are here to stay, and the focus going forward will revolve around the real-world practicalities and challenges such as storage and device training, as well as the quest for market stability. The introduction of adalimumab biosimilars has ushered in cost-savings, marking a potential turning point for healthcare.

References

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2. The IQVIA Institute. Global Use of Medicines 2023. Outlook to 2027. Available at: https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/the-global-use-of-medicines-2023. Last accessed: 11 October 2023.
3. Sunny ME, Wingrove P. Boehringer launches 81% discounted biosimilar of AbbVie’s Humira. Reuters. 2023. Available at: https://www.reuters.com/business/healthcare-pharmaceuticals/boehringer-launches-unbranded-humira-biosimilar-81-discount-2023-10-02. Last accessed: 11 October 2023.
4. Cision PR Newswire. Adalimumab-adbm, Boehringer Ingelheim’s Interchangeable biosimilar to Humira®, now available at low wholesale acquisition cost. 2023. Available at: https://www.prnewswire.com/news-releases/adalimumab-adbm-boehringer-ingelheims-interchangeable-biosimilar-to-humira-now-available-at-low-wholesale-acquisition-cost-301943422.html. Last accessed: 11 October 2023.
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8. Cardinal Health. Cardinal Health 2023 Biosimilars Report. Available at: https://www.cardinalhealth.com/en/product-solutions/pharmaceutical-products/biosimilars/biosimilars-report.html. Last accessed: 11 October 2023.
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