Biosimilar policies in the UK Posted 30/11/2012

The UK was placed in 10th position in the global pharmaceutical markets in 2011 [1]. The UK also had some of the lowest prices for medicines in Europe [2]. Cost pressures and a well-developed generics market mean that the UK is likely to be a fast-adopter of biosimilars. However, relatively low usage of biologicals reduces the UK’s attractiveness as a biosimilars market [3].

The Medicines and Healthcare products Regulatory Agency (MHRA), an agency of the Department of Health (DoH), was created in 2003 and is the governmental body responsible for the licensing of medicines, including biosimilars, in the UK [4].

The UK has in principle a free pricing system. However, the price of pharmaceuticals reimbursable by the National Health Service (NHS) is subject to the Pharmaceutical Price Regulation Scheme (PPRS). This scheme covers brand-name products and excludes generic medicines [5]. Biosimilars, like brand-name products, however, are included under the PPRS.

Substitution and interchangeability
In the UK, automatic substitution in community pharmacies is not allowed. The pharmacist is therefore obliged to supply the product specified on the prescription [6]. This is in accordance with the Medicines Act 1968 and the Royal Pharmaceutical Society of Great Britain’s Code of Ethics, which state, respectively:
‘No person shall, to the prejudice of the purchaser, sell any medicinal product which is not of the nature or quality demanded by the purchaser.’
‘Except in an emergency, a specifically named product is not substituted with any other product, without the approval of the patient or carer, and the prescriber, a hospital drug and therapeutics committee, or other similarly agreed local protocol.’

In February 2008, MHRA also issued the following recommendation:
‘When prescribing biological products, it is good practice to use the brand name. This will ensure that automatic substitution of a biosimilar product does not occur when the medicine is dispensed by the pharmacist.

MHRA adds that ‘products (biosimilar and reference) that have the same international non-proprietary name (INN) are not to be presumed identical’ due to the fact that ‘biological products are fundamentally different from standard chemical products in terms of their complexity, and it is unlikely that the biosimilar product will have an identical structure to that of the reference product, thereby requiring evidence of safety and efficacy before approval’ [7].

Pricing and reimbursement
There are no special arrangements for pricing and reimbursement of biosimilars in the UK. As for other brand-name medicines, they fall under the PPRS regulation. If it is granted a new active substance marketing authorization, the company has the freedom to set the launch price; if it is an already existing substance they have to negotiate the price.

Regarding reimbursement, if the product is licensed and the price approved, reimbursement is at 100% as for non-biosimilars unless a product appears on a small negative list.

Biosimilar launches
Horizon scanning is used to identify launches of all medicines.

Horizon scanning aims to identify in advance treatments that may have significant implications for clinical practice, service design or finance that are likely to become available to the NHS [8]. Information for early horizon scanning is available through access to the UK Medicines Information’s daily updated New Drugs Online database, which contains information about drugs in clinical development through to launch [9].

Related articles

Biosimilar policies in Spain

Biosimilars policies in Italy

Biosimilar substitution in the EU

References

1.  ABPI. Global pharmaceutical industry and market [monograph on the Internet] UK, ABPI [cited 2012 Nov 30]. Available from: www.abpi.org.uk/industry-info/knowledge-hub/global-industry/Pages/industry-market-.aspx

2.  ABPI. The pharmaceutical industry and market in the UK [monograph on the Internet] UK, ABPI [cited 2012 Nov 30]. Available from: www.abpi.org.uk/industry-info/knowledge-hub/uk-economy/Pages/uk-industry-market.aspx

3.  Pisani J, Bonduelle Y. Opportunities and barriers in the biosimilar market: evolution or revolution for generics companies? 2006.

4.  GaBI Online - Generics and Biosimilars Initiative. Licensing Guidelines and Regulations [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 November 30]. Available from: www.gabionline.net/Country-Focus/United-Kingdom/Licensing-Guidelines-and-Regulations 

5.  GaBI Online - Generics and Biosimilars Initiative. Market Analysis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 November 30]. Available from: www.gabionline.net/Country-Focus/United-Kingdom/Market-Analysis 

6.  Rovira J, et al. The impact of biosimilars’ entry in the EU market. January 2011.

7.  MHRA. Biosimilar Products. Drug Safety Update. 2008;1(7):8.

8.  NPC. New medicines - Horizon scanning explained [monograph on the Internet] UK, ABPI [cited 2012 Nov 30]. Available from: www.npc.nhs.uk/new_medicines/horizon.php

9.  UKMi. The UKMi ‘Information on New Products’ Portfolio [monograph on the Internet] UK, UKMi [cited 2012 Nov 30]. Available from: www.ukmi.nhs.uk/activities/newProducts/default.asp?pageRef=3

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