The recommendations highlight the importance of:
- Robust patient safety monitoring; to enable compliance with EU pharmacovigilance legislation
- Clear guidance and information to educate prescribers and patients to ensure they are aware of the important differences between biological medicines and chemically developed (smaller molecule) medicines
The full list of recommendations are highlighted below and more detail on each recommendation can be found in the ABPI position paper which can be viewed here:
Recommendation 1: All biological/biosimilar medicines should be prescribed by brand name and not by International Non-proprietary Name (INN).
Recommendation 2: Automatic substitution is not appropriate for biological medicines including biosimilars. A biological medicine including a biosimilar, must only be substituted under the direct supervision and with the consent of the treating physician.
Recommendation 3: Patients should be kept fully informed about their medication and should be consulted if any changes to their treatment are made.
Recommendation 4: The SmPC for a biosimilar medicine should clearly indicate the source of information contained within it, such as relevant data from its clinical development programme and clinical data derived from the originator or reference biological medicine.
Recommendation 5: Biosimilar medicines should be subject to health technology assessment processes in the UK.
Recommendation 6: Tenders which are undertaken involving biological medicines should not seek to source a single product only.
Recommendation 7: Extrapolation of indications for biosimilar products should be evaluated by regulators on a case by case basis.
Commenting on the publication of the position paper, ABPI Director of Value and Access Paul Catchpole said:
“It is important that both patients and prescribers have a full understanding of the differences between biosimilar medicines and more traditional, chemically produced medicines. This should happen at every stage of a patient’s treatment journey, particularly if there are changes being made to the medicines they receive. The ABPI position paper provides an authoritative list of recommendations to inform the NHS and regulators on the appropriate use of these medicines, and to help ensure patients who would benefit from biosimilar medicines can get appropriate access to them.”
The ABPI and its Biosimilars Group (BSG) are developing a suite of materials to further inform stakeholders and answer frequently asked questions to enhance understanding of biological and biosimilar medicines. These will be made available on the ABPI website later this month.
Notes to editor:
A biosimilar medicine is a biological medicine that is developed to be similar to an approved biological medicine and can only be marketed after the patent and data exclusivity period has ended.
About the ABPI
The ABPI represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK.
Our industry, a major contributor to the economy of the UK, brings life-saving and life-enhancing medicines to patients. Our members supply 90 per cent of all medicines used by the NHS, and are researching and developing over two-thirds of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome diseases.
The ABPI is recognised by government as the industry body negotiating on behalf of the branded pharmaceutical industry, for statutory consultation requirements including the pricing scheme for medicines in the UK.
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