ABPI biosimilars position paper

November 13, 2012 8:00 AM

The Association of the British Pharmaceutical Industry (ABPI) is the trade association for 150 companies in the UK producing prescription medicines for humans. The association issued a position paper about biosimilars and published it on their website today. 

The paper describes the biological medicines and also the regulatory framework in the EU at the beginning.  ABPI mentions that, once biological/biosimilar medicines are authorised within the Union, individual Member States must develop processes regarding the prescription, delivery and use of biological and/or biosimilar products. These processes vary widely across the EU MS. In the UK, health technology assessment (HTA) and NHS procurement processes need to take into account the specific requirements and assessment needs of biosimilar medicines.

Also from the paper, we can get some more details about the current tracking system of biosimilars in the UK: In the UK, the MHRA mandates that all similar biotechnology derived medicines (biosimilars) have a Black Triangle symbol because they are not identical to the originator product and therefore require intensive monitoring for safety and efficacy.

The Black Triangle scheme will be superseded in 2013 by an EU level additional monitoring system which will be mandatory for all biological medicines which were approved after 1st January 2011.

And when we come to the recommendations of ABPI, they can be listed as follows:

Recommendation 1: In order to prevent automatic substitution, all biologic /biosimilar prescriptions should be written by brand name and not by International Nonproprietary Name.

Recommendation 2: Again, with the reference of EMA Guidelines on biosimilars, ABPI insists that, a biologic or biosimilar must only be substituted with the knowledge and 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 summary of medicinal product characteristics (SmPC) should clearly indicate the source of information contained within it, such as relevant clinical studies or that it has been derived from evidence about the originator product

Recommendation 5: Biosimilar medicines should be subject to full Health Technology Assessment processes in the UK

Recommendation 6: Tenders which are undertaken involving biosimilar medicines should not seek to source a single product only

Recommendation 7: There should be no automatic indication extrapolation for biosimilar products

If you want to read the full paper, you can reach the ABPI website from the below link. But just to note, as the Editors of BiosimilarNews, we think almost the opposite of some of the recommendations of ABPI listed above. This is of course from the originators’ point of view but world, especially EU is far ahead of some of the recommendations listed here.

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Source: ABPI biosimilars position paper

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