P0646 Implementing a biosimilar switch

Abstract Background Experience with the use of biosimilars has shown switching between a biosimilar and its originator does not appear to impact on efficacy, safely or immunogenicity. The National Health Service ((NHS) has set targets for the uptake of best value biological medicines for both newly initiated and existing patients to achieve substantial savings for the UK publicly funded healthcare system. In September 2024, Ustekinumab became the third biosimilar available for IBD patients in the UK. Methods Between October 2024 - April 2025 all patients initiated on or due prescription renewal in a large IBD tertiary referral centre were switched from the originator Stelara® to a biosimilar. As with most IBD centres implementation of the switch was predominantly overseen by the pharmacy team. Implementation steps included: Choice and procurement of biosimilar product (consideration of licensing, cost, formulation, presentation, excipients, stability) Patient notification via letter from the clinical team notifying them of the change and rationale Updating the Service Level Agreement with a homecare delivery company to dispense, deliver and provide administration support as required Providing a patient support line to answer queries and concerns One off face to face clinic for those requiring additional reassurance Collecting baseline data e.g. c-reactive protein and faecal calprotectin to be repeated at 6 and 12 months to assess the effectiveness, safety and tolerability of the biosimilar Results In the 6 month transition period 482 patients were prescribed a biosimilar. 79% (n = 381) were switched from the originator as their current prescription expired and 21% (n = 101) were initiated on ustekinumab treatment with biosimilar. 2.6% (n = 10) contacted the clinical team with concerns which included a belief there was a complete change in medicine, a reduction in efficacy or potential for new side effects. 50% of these were seen face to face in clinic with a consultant and pharmacist. All ten patients agreed to subsequently switch. One patient switched back due to side effects 3.7% (n = 18) were switched to alternative treatment due to loss of response. Conclusion We successfully introduced another biosimilar medicine for the treatment of patients with Inflammatory Bowel Disease as part of ongoing efforts to enhance care and improve value for the NHS. The changeover to the biosimilar was carefully planned with the pharmacy team, IBD specialist nurses and Gastroenterologists all integral to the process with careful communication and support for affected patients. This collaborative team approach has enabled us to deliver sustainable care with savings that can be reinvested into patient care and service improvements. References: Department of Health and Social Care (DHSC), 2023. Guidance on the licensing of biosimilar products. [online] GOV.UK. Available at: https://www.gov.uk/government/publications/guidance-on-the-licensing-of-biosimilar-products/guidance-on-the-licensing-of-biosimilar-products [Accessed 21 May 2025]. European Medicines Agency (EMA), 2022. Statement on the scientific rationale supporting the interchangeability of biosimilar medicines in the EU. [pdf] Available at: https://www.ema.europa.eu/en/documents/public-statement/statement-scientific-rationale-supporting-interchangeability-biosimilar-medicines-eu_en.pdf [Accessed 21 May 2025]. NHS England, 2023. What is a biosimilar medicine? [online] Available at: https://www.england.nhs.uk/publication/what-is-a-biosimilar-medicine/ [Accessed 21 May 2025]. Specialist Pharmacy Service (SPS), 2023. Understanding biological and biosimilar medicines. [online] Available at: https://www.sps.nhs.uk/articles/understanding-biological-and-biosimilar-medicines/ [Accessed 21 May 2025]. Conflict of interest: Cripps, Sarah: Consultancy fees: Abbvie, Advanz, Dr Falk, Galapagos, Pfizer, Lilly, SALTs healthcare, Sandoz, Takeda Sponsorship: Abbvie, BMS, Celltrion, Gilead, Lilly, Tillots Sanford, Jack: No conflict of interest Azzu, Hanan: speaker fees Takeda, Pfizer