British Biosimilars Association (BBA) launches in UK

A new industry body, the British Biosimilars Association (BBA), has been launched with the sole focus of increasing the understanding and use of biosimilar medicines in the UK.

The BBA is the expert sector group of the British Generic Manufacturers Association (BGMA) exclusively focused on biosimilar medicines.

The core focus of BBA members will be ensuring that patients can benefit from these medicines to the same extent as people living elsewhere in Europe. Currently, the UK lags behind some European countries in the take-up of biosimilar medicines. Restricting patient access to these medicines costs the NHS money that could be used for other treatments.

Biological medicines are protein based and made or derived from living organisms. They can be tailormade so that they bind to specific targets in the body, something that is not possible with conventional medicines. A biosimilar medicine is manufactured to be similar to an existing licensed 'reference' biological medicine after expiry of its patent, with no meaningful differences in terms of quality, safety or efficacy.

Currently, there are seven biosimilar molecules on the market in the UK (somatropin, follitropin alfa, filgrastim, infliximab, epotein alfa, insulin glargine and etanercept). But this is set to increase due to a number of factors, including patent expiries, increasing clinical awareness and knowledge, as well as supportive guidance from organisations such as National Institute for Health and Care Excellence (NICE) to generate confidence in using these products.

Keith Ridge, NHS England’s Chief Pharmaceutical Officer, said: 'We very much welcome the creation of the British Biosimilars Association with its clear focus on providing information about these vitally important medicines. Biosimilar medicines have enormous potential to deliver increased patient access, as well as savings to the NHS which can be reinvested elsewhere. It is important that clinicians are aware of their potential and that wherever appropriate biosimilar competition is encouraged. We look forward to continuing to work with the BBA and its members to that end.'

Tim de Gavre, Chair of the BBA, added: 'Biological medicines are playing a significant role on a global scale in providing effective treatments for patients and contributing to improved survival rates for patients as well as providing better quality of life.

'These medicines are much larger in size and more complex than traditional small molecule equivalents and are considerably more expensive to develop and manufacture. Therefore biosimilar medicines – equivalents which have no meaningful differences from the reference product in terms of quality, safety or efficacy – have a significant role to play in providing better access for patients, choice for clinicians, driving down cost to the NHS and ultimately improving health outcomes for patients. Biosimilars also have a role in creating budget headroom so that the NHS can afford new and innovative therapies.

'Our role through the BBA is to promote the benefits of these medicines to patients’ representatives, healthcare professionals, regulators and payers, to increase understanding and to drive a sustainable environment for the development, production and continuing optimised use of biosimilar medicines across the UK.'

The new association is open to all manufacturers of biosimilar medicines – not just BGMA members – who wish to promote their use in the interests of British patients.

The Association’s founder members are Accord, Allergan, Boehringer Ingelheim, Napp, Sandoz and Teva.

Towards the end of last year, NHS England, in collaboration with industry and regulatory partners, launched a ‘What is a biosimilar?’ briefing. The document provides key clinical and non-clinical stakeholders with accessible information on how to support the appropriate use of all biological medicines, including biosimilar medicines for the benefit of NHS patients. Drawing on NHS, regulatory, professional and industry expertise, the document provides an authoritative source of reference on this complex topic.

Elsewhere, national and regional meetings have been held to increase awareness of biosimilars among key audiences. Additionally, NICE has published information on implementing specific biosimilars in the NHS such as infliximab.