Biosimilar Adoption in the UK: Patient and Consultant Views on Safety and Switching

Key findings showed that there continues to be a lack of understanding and/or confidence in biosimilars among providers and patients, leading to diminished provider willingness to prescribe biosimilars and patient perceptions about the safety of switching to a biosimilar.

The UK-based study, published in Pharmacy, aimed to describe the opinions of patients undergoing treatment with originator biologics and medical consultants managing their conditions and identify barriers and enablers to switching to a biosimilar.¹

“The patient needs to be assured that the process is not just a cost-saving exercise but will allow additional services to be provided across the NHS [National Health Service] to patients, that the treatments are equivalent to their biologics, effective, and equally safe as adverse drug reactions were a concern for the patients, and that an option to revert back would be available to them,” wrote the authors.

Biologics target specific immune proteins to reduce inflammation but are expensive and often used after other treatments fail. Biosimilars entered the UK market beginning in 2006, allowing earlier treatment and expanded access. Unlike generic drugs, biosimilars are not identical to their reference biologics, which has caused concerns about the safety of switching to biosimilars among providers and patients.

In November 2022, the UK’s Medicines and Healthcare products Regulatory Agency updated its guidance on licensing biosimilar products, stating that authorized biosimilars are interchangeable with their reference products and other biosimilars to the same reference product.² This means prescribers can expect the same therapeutic effect when switching between them, making such switches standard clinical practice. However, switching safety concerns persist.

Despite evidence of their safety and effectiveness, gaps in prescriber knowledge and patient doubts hinder biosimilar adoption. Spending on biologics and biosimilars in the UK rose from £6.63 billion ($8.4 billion) in 2017 to £9.45 billion ($11.9 billion) in 2023, with biosimilars helping to control costs. The authors stressed that effective communication from health care providers will be crucial to address concerns and prevent patients from experiencing negative outcomes after switching to biosimilars caused by the nocebo effect. Studies have also emphasized the need for through education to ensure successful transitions to biosimilars and maximize cost savings.

This study explored views on switching from originator biologics to biosimilars using focus groups and interviews. Nine patients and 5 consultants took part in the analysis. Patients on infliximab (n = 2) or etanercept (n = 7) were randomly selected for focus groups, while medical consultants were individually interviewed. The primary researcher, a registered pharmacist, conducted the study. Patients had to be on their medication for at least 6 months. An 80% response rate was achieved, but many participants couldn't attend initially, prompting a second round of invitations. Consultants were invited via email for 45-minute interviews. Both focus groups and interviews were recorded and transcribed.

The focus groups included a presentation on biologics and biosimilars to ensure consistent knowledge. Discussions covered the impact of switching, communication methods, and necessary patient information. Data were anonymized and analyzed to identify themes.

Five consultants from gastroenterology, dermatology, and rheumatology participated in face-to-face interviews. At the time of the study, none had prescribed biosimilar medicines. Four main themes were identified:

1. Benefits to the NHS
2. Efficacy and safety evidence
3. Team roles
4. Effective communication during switching

There was consensus among consultants about the financial benefits of switching from biologics to biosimilars. The savings could be redirected within the NHS or used to increase patient access to treatments. One consultant highlighted that lower costs could lower the threshold for prescribing these drugs, allowing more patients to benefit.

Consultants agreed that evidence of biosimilar efficacy and safety was crucial for making the switch. Most trusted the regulatory approvals from bodies like the FDA and European Medicines Agency as sufficient evidence. Concerns about adverse effects were noted, but they were seen as similar to those of reference biologics. One consultant expressed caution, preferring more data before switching. Manufacturer reputation was also important, with some consultants trusting known manufacturers more. There was concern that lower costs might lead to higher adverse event reporting. Despite this, most consultants agreed that monitoring should remain the same as for biologics, with some suggesting more intensive monitoring initially until more robust data was available.

The consultants felt that doctors or specialist nurses should handle the communication about switching to biosimilars, rather than pharmacists, especially if there was no preexisting relationship with the patient. Effective communication might require additional resources, and there was concern about having enough personnel to support the enhanced patient contact required.

Regarding effective communication, results showed a distinction between what patients want to know and how the information should be communicated. Patients need time to process information about switching to biosimilars. They should be given time to review and absorb this information and have the option to revert to the original biologic if they experience issues. This option was seen as important for patient reassurance and acceptance of the switch.

Both written and face-to-face communication were preferred for informing patients about the switch. Simple information sheets and frequently asked question documents were recommended to avoid overwhelming patients with too much information at once. Consultants noted that upfront information could prevent unnecessary anxiety later. Information from hospitals was seen as more trustworthy than from manufacturers. Transparency about the reasons for switching, cost savings, and examples of what the savings could fund were also deemed important. For instance, one consultant suggested explaining that the savings could fund additional treatments or procedures, enhancing patient understanding and acceptance of the switch.

The study had limitations, including no double coding and a small sample size for the infliximab originator focus group. Although it included gastroenterology, rheumatology, and dermatology representations, the lack of time to repeat focus groups and ensure data saturation was a limitation. Further research should focus on equality, diversity, and inclusivity, particularly involving marginalized groups prescribed biosimilars. Socioeconomic and ethnic backgrounds were not captured but were broadly representative of the local population.

References

1. Rosembert DC, Twigg MJ, Wright DJ. Patient’s and consultant’s views and perceptions on switching from an originator biologic to biosimilar medication: a qualitative study. Pharmacy. 2024;12(2):65. doi:10.3390/pharmacy12020065

2. Guidance on the licensing of biosimilar products. MHRA. Updated November 7, 2022. Accessed June 26, 2024. https://www.gov.uk/government/publications/guidance-on-the-licensing-of-biosimilar-products/guidance-on-the-licensing-of-biosimilar-products