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High-alert therapy area: Respiratory biologics are among the most complained-about products at the PMCPA. Competitor biologic comparisons (Dupixent vs Nucala vs Fasenra), ICS step-down claims and patient support programme compliance are consistent triggers for formal proceedings.
Comparative claims between IL-5, IL-4/IL-13 and IL-33-targeting biologics — Dupixent, Nucala, Fasenra, Tezspire — without head-to-head data are a top source of PMCPA complaints. Indirect comparisons require careful qualification.
Promoting biologics outside their licensed indication, including implied use in phenotypes or severity bands not covered by NICE approval, is a consistent regulatory risk for respiratory teams.
Claims suggesting patients can step down from ICS/LABA combinations following biologic initiation, without robust supporting data and appropriate clinical context, have attracted regulatory scrutiny.
Claims about inhaler technique, device superiority or convenience that go beyond licensed indications or lack robust comparative evidence — particularly for ICS/LABA devices — present real risk.
Respiratory patient support programmes, particularly those linked to biologic initiation, must comply with ABPI Code requirements on nurse educator services, financial support and third-party relationships.
Using exacerbation reduction data from clinical trials in promotional materials requires careful attention to patient population, trial design and whether the claim is supported across the licensed indication.
Built specifically for pharma teams working in respiratory — not generic compliance content repurposed for your therapy area.
The pack includes expert walkthroughs of all relevant PMCPA adjudications in the respiratory space. Here are three landmark cases.
The pack includes all relevant respiratory PMCPA cases with video walkthroughs, expert commentary and quiz questions.
MSLs and medical advisors presenting biologic data, responding to off-label questions and managing HCP relationships in respiratory medicine and allergy
Sales representatives and brand managers responsible for biologic promotional materials, device claims and CRM communications to respiratory specialists
HEOR and market access teams making NHS, NICE and formulary claims for respiratory biologics and ICS/LABA products in promotional and non-promotional contexts
Regulatory affairs and compliance officers reviewing respiratory promotional materials, patient programmes and device claims against the ABPI Code 2024
Speak to us about the Respiratory Compliance Pack. Tell us your team size and therapy area focus and we'll put together the right package.
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PD-1/PD-L1 inhibitors, CDK4/6 inhibitors, PARP inhibitors. OS vs PFS claims, biomarker-driven promotion and compassionate use.
All 2,000+ PMCPA cases. Video. Podcast. Quiz. 5 points per case. The only case library of its kind in the UK.
12 therapy area packs covering Respiratory, Oncology, Cardiovascular, CNS, Diabetes, Immunology, Infectious Diseases, Dermatology, Musculoskeletal, Ophthalmology and more.
One real case. One key lesson. Every week — free.