BIA and ABPI Launch Factsheets on Biological Medicines

The Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA) have jointly developed materials on biological and biosimilar medicines to improve understanding of these medicines and answer any frequently asked questions.

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. Since 2006 over 18 branded biosimilar medicines have been granted marketing authorisations in the EU and it is predicted that by 2016 seven of the top ten medicines worldwide will be biologics.

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.

 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 in order 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.”

 BIA Chief Executive Officer Steve Bates added “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.

The materials can be downloaded from the ABPI and BIA websites.