Low Biosimilar Awareness in MS Patients Points to Critical Gap in Nurse-Led Education

Most people with multiple sclerosis had never heard of biosimilars—even while taking them—a new Italian study reveals, raising urgent questions about patient education gaps in MS care.1

Biosimilar Blindspot: Over 60% of MS Patients Reported No Prior Awareness

Despite the growing availability and clinical adoption of biosimilar therapies for multiple sclerosis (MS), a large majority of people actively treated with these agents had never heard of them before beginning therapy, according to the cross-sectional study published in BMC Nursing. The finding underscores a significant informational deficit that may be shaping—and limiting—biosimilar acceptance across the MS care continuum.

Biosimilar therapies have emerged as a central strategy for improving affordability and expanding patient access to high-cost biologic treatments, including agents used in relapsing forms of MS. The recent approval of biosimilar natalizumab (studied in the Antelope phase 3 trial, NCT04115488) exemplifies this trend.2 Yet patient resistance to initiating or switching to biosimilars remains a documented challenge—one that researchers increasingly attribute not to entrenched opposition but to gaps in health literacy and what is known as the nocebo effect, wherein negative expectations drive perceived adverse outcomes.

To better understand how informational experiences and health literacy shape biosimilar acceptance in this population, researchers in Italy conducted a multicenter observational study using a newly developed, theory-informed questionnaire structured around 4 health literacy domains: access, understand, appraise, and apply.

Study Design and Patient Demographics

The study was conducted from March to May 2025 across multiple Italian health care facilities through the Italian Network of Multiple Sclerosis Nurses. A total of 99 adults with confirmed MS diagnoses—representing a 49.5% response rate—completed the questionnaire. Participants had a mean (SD) age of 44.3 years (11), and 71.7% were female. Most were married or cohabiting (62.6%), and the sample was highly educated, with nearly half holding a university degree (47.5%). The majority of participants resided in Southern and Central Italy, with the largest proportion from Puglia (46.5%).

The questionnaire was developed through an iterative process that included interdisciplinary expert review and patient focus groups using a think-aloud method, ultimately yielding a 23-item instrument.

Knowledge Gaps Ran Deep Across All 4 Health Literacy Domains

In the access domain, 62.6% of participants reported never having heard of biosimilar drugs before beginning treatment. Most participants—94.9%—had received some information from a health care professional, but verbal explanation alone accounted for 91.5% of all informational delivery; printed materials and structured educational sessions were used in only 2.1% and 1.1% of cases, respectively.

Comprehension-related findings were similarly concerning. The item assessing perceived adequacy of information yielded the lowest mean (SD) score of the 4 domains (2.68 [1.04]), with 38.4% of participants disagreeing or strongly disagreeing that they felt adequately informed—compared with only 21.2% who agreed or strongly agreed.

In the appraise domain, trust in health care professionals was relatively high (mean [SD], 3.29 [0.94]), yet 35.3% disagreed or strongly disagreed that clinicians had provided complete information. Nearly half of respondents (45.4%) reported independently seeking additional information beyond what providers had shared—a pattern the researchers flagged as a potential vulnerability to misinformation.

The apply domain offered some encouraging findings. Acceptance of biosimilars for first-line treatment initiation showed the strongest positive response, with 49.5% of participants agreeing or strongly agreeing they would use a biosimilar if recommended by their physician. Nurse advice was reported as decisive or very influential on treatment decisions by 82.8% of participants, while physician advice reached that threshold among 92.9%.

MS Nurses Identified as Underutilized but Pivotal in Biosimilar Education

A key finding of the study was the substantial—yet largely untapped—role of MS nurses in shaping patient knowledge and therapeutic decision-making. Nurses were the first source of information about biosimilars for 36.4% of participants, compared with 52.5% who first received information from a physician. The authors noted that, given their frequency of patient contact and continuity of care, nurses are uniquely positioned to reinforce education and address informational gaps across the entire treatment journey.

As the authors wrote, "Biosimilar acceptance in MS appears to be shaped more by difference in health literacy processes than by negative attitudes. MS nurses play a pivotal role in addressing these gaps, supporting informed understanding, reducing uncertainty, and guiding therapeutic decision-making."

Limitations Temper the Findings

The authors acknowledged several limitations. The cross-sectional design prevents causal conclusions. The relatively small sample (n = 99), convenience sampling strategy, and geographic concentration in Southern Italy limit generalizability. The sample's high educational attainment and female predominance may not reflect the broader MS population. All data were self-reported, introducing potential recall and social desirability bias. Additionally, the questionnaire used in this study has not yet undergone formal psychometric validation for reliability or construct validity, meaning the results should be interpreted as exploratory.

Implications for Managed Care and Policy

These findings carry practical relevance for managed care organizations and health systems working to promote biosimilar uptake. Patient education remains a critical and potentially modifiable barrier to biosimilar adoption—one that nurse-led communication strategies may be well-positioned to address. Strengthening structured, tailored educational interventions delivered by MS nurses could represent a cost-effective lever for improving biosimilar acceptance and, ultimately, supporting sustainable biologic prescribing.

Reference

1. Pastore F, Cicolini G, Forastefano B, et al. Health literacy and biosimilar acceptance in people with multiple sclerosis: a cross-sectional study. BMC Nurs. 2026;25(1):482. doi:10.1186/s12912-026-04660-6
2. Hemmer B, Wiendl H, Roth K, et al. Efficacy and safety of proposed biosimilar natalizumab (PB006) in patients with relapsing-remitting multiple sclerosis: the Antelope phase 3 randomized clinical trial. JAMA Neurol. 2023;80(3):298-307. doi:10.1001/jamaneurol.2022.5007