Insulins were administratively reclassified from drugs to biologicals in 2020, creating a streamlined pathway for more affordable biosimilar and interchangeable insulins to enter the market. Prior to 2020, originator insulins were regulated as 505(b)(1) drugs, with follow-on insulins approved via an abbreviated 505(b)(2) pathway. These insulins were not considered biosimilars in the US due to this reason. With the reclassification, insulins are now regulated as 351(a) biologicals, with an option to develop biosimilars and interchangeable biologicals using the 351(k) regulatory pathway [1]. To date, there are two insulin biosimilars approved in the US [2], one of which (Semglee) also has an interchangeability designation [3].

In a viewpoint article, authors from generics maker Sandoz, discuss how insulin biosimilars may face adoption challenges due to concerns about safety, immunogenicity, interchangeability and patient perception [4]. The US Food and Drug Administration (FDA) requires a rigorous development programme for biosimilar approval to ensure there are no additional safety and immunogenicity concerns beyond those known with the reference biological. No differences in immunogenicity have been observed to date with any biosimilar in the US or Europe, whether it is for initial use or if switched from an originator reference product.

White et al. discuss how negative patient perceptions, such as believing biosimilars are inferior in efficacy, safety, or quality to the reference biological, can lead to a nocebo effect. This induces unwanted pharmacologic effects that are unrelated to the treatment’s mode of action, leading to lower adherence rates and quality of life. Biosimilar clinical and real-world evidence education is key to increase understanding of biosimilars for patients.

Insulin biosimilars may provide patients the same benefit-risk profile as the reference insulin at a substantially lower cost, increasing affordability and accessibility to insulins. White et al. showed how this was demonstrated in a recent analysis conducted on the costs and net sales of insulin glargine products over a 10-year period. Basaglar availability was associated with a significant downward trend in net price for Lantus (decreased on average 5.2% per quarter, p <0.001) and average price (decreased 3.4% quarterly) across insulin glargine products.

Rising prescription drug costs continue to be a key issue at the federal, state and private insurer level. Multiple committees of the 116th US Congress held hearings on insulin affordability and members introduced legislation that directly and indirectly addressed insulin, some of which continue to be considered in the 117th Congress. In August 2021, the Biden administration issued a statement urging Congress to implement reforms that would lower prescription drug cost, including insulins.

To address out-of-pocket costs, the Centers for Medicare* and Medicaid Services announced a new Part D** Senior Savings Model in 2021, capping out-of-pocket insulin costs for beneficiaries at US$35 per 30-day supply during the plan year. At least 18 states passed legislation to cap out-of-pocket insulin costs. Private insurers are also offering co-payment caps or programmes that lower or eliminate out-of-pocket costs.

The authors concluded that the rising cost of insulin continues to be a challenge for all stakeholders involved; however, steps are being taken to improve the diabetes landscape. Numerous policies have been proposed and will continue to be pursued regarding insulin access and affordability. White et al. say that although insulin biosimilars may decrease drug and healthcare costs and increase patient access by introducing competition, potential challenges still exist. The authors therefore suggest that awareness of these challenges and addressing considerations for uptake through education are key to ensure that both patients and healthcare professionals are comfortable with insulin biosimilars.

*Medicare is a national social insurance programme, administered by the US federal government since 1966. It provides health insurance for Americans aged 65 and older who have worked and paid into the system, as well as to younger people with disabilities.
**Medicare Part D is an optional programme to help Medicare beneficiaries pay for their prescription drugs.

Conflict of interest
The authors of the research paper [4] declared that they are employees of Sandoz, and that this viewpoint article was supported by Sandoz.

Abstracted by Jentora White-Richardson, PharmD, Regulatory Writing and Submissions (RWS), Global Development Operations (GDO), Sandoz, New Jersey, USA.

Editor’s comment
Readers interested to learn more about policies for biosimilars are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

Can local policies on biosimilars optimize the use of freed resources – experiences from Italy

GaBI Journal is indexed in Embase, Scopus, Emerging Sources Citation Index and more.

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

GaBI Journal Citation Impact
1.9 – CiteScore 2020 (calculated on 5 May 2021)
2.2 – CiteScoreTracker 2021 (Last updated on 5 January 2022)

Submit a manuscript to GaBI Journal

Related article
Biosimilars of insulin glargine

References
1. GaBI Online - Generics and Biosimilars Initiative. Comments on FDA’s plans to transition insulin products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Feb 4]. Available from: www.gabionline.net/Guidelines/Comments-on-FDA-s-plans-to-transition-insulin-products
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Feb 4]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-approved-in-the-US
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Feb 4]. Available from: www.gabionline.net/biosimilars/news/FDA-approves-first-interchangeable-insulin-glargine-biosimilar
4. White J, Wagner A, Patel H. The impact of biosimilar insulins on the diabetes landscape. J Manag Care Spec Pharm 2021;28(1):91-8.

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2022 Pro Pharma Communications International. All Rights Reserved.