Introduction to Biosimilars for Immune-Mediated Inflammatory Diseases: 2022 Update

Am J Manag Care. 2022;28(suppl 12):S215-S216. https://doi.org/10.37765/ajmc.2022.89295

Biosimilars are biologic products that are highly similar to existing FDA-approved biologics, with no clinically meaningful differences in terms of safety, efficacy, purity, and potency.¹ The regulatory approval process for biosimilars represents innovation and regulatory advancements in bringing these vital biologic therapies to market via an expedited pathway intended to reduce delays and costs, based on the concepts of extrapolation and totality of evidence. With biologics representing some of the most costly treatments available, biosimilars have the potential to drive price competition, resulting in cost savings and increased patient access to critical biologic treatments.² The FDA has approved biosimilars for the treatment of immune-mediated inflammatory diseases such as rheumatoid arthritis, Crohn disease, and ulcerative colitis.³ Article 1 of this supplement presents an overview of these biosimilars and provides a summary of the current evidence associated with them.⁴

Prescriber and patient confidence in biosimilars has increased over the years, particularly in select therapeutic areas like oncology, but there is still room for significant improvement more broadly. The education of patients and caretakers, nurses, pharmacists, physicians, payers, and other health care stakeholders will be crucial for biosimilars to be widely adopted. Article 2 discusses how patients, physicians, and pharmacists may perceive the potential benefits of biosimilars and the barriers to their uptake, based on evidence from surveys.⁵ Some health care providers (HCPs) are still cautious about using biosimilars, given that the potential cost savings may not be immediately apparent within the US health care system.⁶ Diseases treated with biologic products often have debilitating symptoms; this can lead to a hesitancy to switch a patient who is being successfully treated and maintained on a biologic reference product, particularly in the absence of meaningful cost savings to the patient. However, acceptance and willingness to prescribe biosimilars are more associated with treatment-naive patients, given the ability to initiate treatment earlier in the disease course.⁷

Pharmacists, who often have an intermediary role between both patients and prescribers, play an important role in communicating the efficacy and safety of biosimilars. As such, they are well positioned to enable and support successful biosimilar adoption. Education and information via HCPs, including prescribers and pharmacists, will play a key role in easing the transition of a patient to a biosimilar or in initiating a new patient on a biosimilar treatment. However, many HCPs would benefit from more clarity on topics such as substitution and interchangeability.^8,9

Article 3 provides an additional look into biosimilar experiences thus far, with a deeper dive on the managed care landscape, which significantly influences biosimilar performance in the United States.¹⁰ Considerations associated with designation of a biosimilar as interchangeable and its applicability are also highlighted in this article. Interchangeability, a regulatory designation unique to the United States, allows pharmacist-level substitution per state laws. However, interchangeability continues to be one of the most commonly cited knowledge gaps among providers, contributing to barriers to adoption. Closing key knowledge gaps and increasing accessibility to biosimilars would help to drive competition and innovation in the treatment of immune-mediated inflammatory diseases, potentially decreasing the overall systemic financial burden.¹¹ However, the US health care system may unintentionally encourage the use of higher-cost medications due to misaligned incentives within the current opaque health care delivery model. These incentives can result in inclusion of higher-cost medications on formulary lists or encourage them to be included on a lower formulary tier than a less expensive biosimilar. Inconsistent coverage, combined with the administrative burden to prescribers who may need to obtain a prior authorization to prescribe a nonformulary medication, decreases the likelihood of a biosimilar being prescribed.

Biosimilars offer potentially significant opportunities for cost savings and for increased access to biologic products that are used to treat immune-mediated inflammatory diseases, with no compromises in efficacy and safety. However, the real-world benefits they ultimately deliver under the current system will be determined by their acceptance across the managed care landscape, including the pharmacy benefit managers and payers, among other considerations. The necessary education, regulatory, and legislative reforms that are needed to improve the uptake of biosimilars would benefit not only their intended population, but also society as a whole due to accelerated health care innovation that is derived from market competition. Greater cost transparency, changes to limit or simplify the legal barriers that slow the release of biosimilars, reductions of the administrative burden associated with prescribing a biosimilar, and enhancements to reimbursement models to improve formulary access could vastly improve accessibility of affordable biologics for many patients. These changes could have both short-term cost savings opportunities and long-term benefits by paving the way for the next generation of cutting-edge therapies.

Acknowledgments

The author meets criteria for authorship as recommended by the International Committee of Medical Journal Editors. Medical writing assistance, supported financially by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI), was provided by Andy Shepherd, PhD, CMPP, of Elevate Scientific Solutions during the preparation of this manuscript. BIPI was given the opportunity to review this manuscript for medical and scientific accuracy as well as intellectual property considerations.

Author Affiliation: Cardinal Health, Dublin, OH.

Funding Source: This supplement was supported by Boehringer Ingelheim Pharmaceuticals, Inc.

Author Disclosures: Dr Oskouei reports employment with Cardinal Health, whose clients include pharmaceutical companies.

Authorship Information: Concept and design; drafting of the manuscript; and critical revision of the manuscript for important intellectual content.

Address Correspondence to: Sonia T. Oskouei, PharmD. Email: sonia.oskouei@gmail.com

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