skip to main content

Biosimilar Pharmacovigilance — SCE Rheumatology MCQ

Instant feedback + full explanation. One question, done properly.

EasyRheumatology PharmacologyBiosimilar PharmacovigilanceSCE Rheumatology

A 55-year-old woman with rheumatoid arthritis has received the adalimumab biosimilar Imraldi (SB5) for 2 years. She develops a clinically significant suspected adverse drug reaction that warrants reporting through the Yellow Card scheme. Which approach best supports appropriate prescribing and pharmacovigilance in the UK?

Educational content. Not a substitute for clinical judgement or local policy.

Reveal the answer and explanation

Correct answer: D — Prescribe and record the biological medicine by brand, and include its brand name and batch number in the Yellow Card report

The correct answer is D. Biological medicines, including biosimilars, require product- and batch-level traceability because different products share the same international non-proprietary name and safety signals may be brand- or batch-specific. Imraldi should therefore be prescribed and recorded by brand, with its batch number documented. A Yellow Card report should identify the substance, specific brand and batch number. Reporting only “adalimumab” is inadequate for product-specific pharmacovigilance. Suspected reactions are not exempt from reporting merely because the product is a biosimilar or is no longer under additional monitoring. Reporting is not restricted to originator products, and automatic pharmacy-level substitution of biological medicines without consulting the prescriber is not permitted in UK practice.

Reference: Medicines and Healthcare products Regulatory Agency. Guidance on the licensing of biosimilar products, sections 9–11: Traceability, Interchangeability and Substitution. Updated 27 February 2025. https://www.gov.uk/government/publications/guidance-on-the-licensing-of-biosimilar-products/guidance-on-the-licensing-of-biosimilar-products