BIA and ABPI jointly launch new communication materials to enhance understanding of biosimilar medicines

The Association of the British Pharmaceutical Industry (ABPI) and the Bioindustry Association (BIA) have jointly developed materials on biological medicines, including biosimilar medicines, to enhance prescribers’ and other stakeholders’ understanding of these medicines and answer any frequently asked questions.

The new materials provide an interesting overview on this ever-growing market at a significant time, with biological medicines — which include biosimilar medicines — now amongst today’s most important medicines. Interesting facts in the materials include

• It is predicted that by 2016 seven of the top ten medicines worldwide will be biologics.
• Since 2006, over 18 branded biosimilar medicines have been granted marketing authorisations in the EU.
• The introduction of biological medicines in the early 1980s revolutionised treatment for some life-threatening and rare diseases, such as cancer, diabetes, blood conditions, rheumatoid arthritis, multiple sclerosis and autoimmune disorders.
• The number of biosimilar medicines available in the UK is expected to increase with biosimilar medicines entering a much wider range of therapy areas, including rheumatoid arthritis, oncology and diabetes.
• It is recommended by the ABPI and BIA that all biological medicines, including biosimilar medicines, should be prescribed by brand name, and not by international non-proprietary names (INN), to ensure accurate reporting and analysis of suspected adverse reactions.
• Automatic substitution is not appropriate for biological medicines, including biosimilar medicines. These must only be substituted under the direct supervision and with the consent of the treating physician.

Commenting on the publication of these documents, ABPI director of value and access Paul Catchpole, said: “A number of ABPI and BIA members are developing biosimilar medicines and we are therefore building relationships with key stakeholders at a national and local level to improve understanding of biological medicines, including biosimilar medicines. These new informative materials will assist in ensuring that these medicines are well understood and used appropriately for the benefit of all eligible NHS patients.”

Commenting, BIA CEO Steve Bates, said: “Biological medicines, including biosimilar medicines, have complex molecular structures and unique manufacturing processes. The development of biosimilar medicines involves many technical challenges and requires distinct regulatory pathways from those applied to generic medicines. For this reason the BIA has been actively engaged in the development of EMA guidelines on biosimilar medicines, including biosimilar monoclonal antibodies over a period of many years, highlighting the issues to be addressed and ensuring that patient safety remains paramount.

“With much support from our members and working in partnership with colleagues at the ABPI we have developed these educational materials to reflect the latest developments in this evolving field. We hope that they will assist healthcare professionals in particular to be aware of, and better understand the challenges of, the introduction of biosimilar medicines to the NHS.”