Introduction
The British Biosimilars Association (BBA) is the expert sector group of the British Generic Manufacturers Association (BGMA) exclusively focused on biosimilars.
Who we are
The membership of the British Biosimilars Association (BBA) comprises a wide group of manufacturers active in the development and production of biosimilar medicines including those who have successfully manufactured and sold them in the UK for the past ten years.
The members of the BBA ensure access for UK patients to biosimilar medicines approved to the same high standards of safety, quality and efficacy as the originator or reference products. As industry experts, we partner with patients’ representatives, healthcare professionals, regulators and payers to increase understanding and to drive a sustainable environment for the development, production and optimised use of biosimilar medicines across the UK.
Our challenge
We have a market in the UK where off patent generic medicines fulfil over three-quarters1 of all prescriptions for conventional medicines, delivering some of the lowest medicines prices in Europe as a result.
For biosimilar medicines however, despite prolonged use in the UK since 2006, subsequent NICE guidance and resources as well as recent NHS England support for the appropriate use of biosimilars, there remains a surprisingly low up-take in using biosimilar treatments in the UK compared to a number of other European countries8 and variance between different Trusts in England.9
As of 2014, eight out of the top ten medicines sold in Europe were biological medicines.12 Given five of the top seven biologics will lose patent by 2020, biosimilars may play a profound role in the future of healthcare, allowing more patients to benefit from effective and proven treatment options.5
Demand for important but expensive biologic medicines is expected to increase, further stretching payer expenditures and thus limiting patient access. By introducing competition, biosimilar medicines offer more choices at competitive prices thereby providing the opportunity to increase patient access without increasing overall spending. Furthermore, competition from biosimilars can free up resources to help fund new medical breakthroughs, with competition motivating producers of patent protected medicines to develop innovative products – driving the 'virtuous circle' of innovation and contributing to the financial sustainability of EU healthcare systems2.
We expect to see this virtuous circle develop in the UK in the next few years due to the loss of patent exclusivity on key molecules, combined with a rapidly developing biosimilar pipeline, resulting in multiple drug launches in long-term and life-saving therapeutic areas such as rheumatoid arthritis, cancer treatments and diabetes. The biosimilar market is therefore set to grow, providing the opportunity to improve access for patients to life transforming biological medicines and potentially saving the NHS hundreds of millions of pounds6,7 at a time when the NHS is looking to find £22bn in efficiency savings by 2020.10
For example, data based on 2010 usage of human growth hormone (hGH) at The North Central London Formulary and Medicines Management Group at University College London Hospitals NHS Trust suggests, annual cost savings in excess of £200,000 per annum are possible from a single centre if all patients were switched from originator hGH3 to biosimilar hGH . Savings generated through biosimilars can be reallocated in the same disease area to help fund access to recent innovative products or help fund access in other disease areas.4
Our approach and activities
The British Biosimilars Association is dedicated to furthering confidence in and education on the benefits of biosimilars for the NHS, patients and health care professionals. To this end we set out clear policy positions on a range of topics to advance the understanding and rapid adoption of biosimilar medicines and sign- post stakeholders to a range of authoritative resources in support of this goal.
We have produced resource materials on the following important biosimilar topics:
• Extrapolation
• Sustainable pricing, procurement and reimbursement
• Interchangeability
• Switching
• Patient access
We will continuously update our materials in response to this rapidly changing environment.
We have worked alongside NHS England , NICE, the MHRA and professional groups and other industry colleagues including ABPI, and other key stakeholders in developing materials such as the production of ‘What is a biosimilar?’ We participate actively in education programmes such as the NHS England biosimilar national and regional meetings. We have regular dialogue with patient and health professional bodies advocating accurate and transparent information on biosimilars.
Members
1 NHS Digital, Prescriptions Dispensed in the Community, Statistics for England - 2005-2015. Available here
2 IMS, Delivering on the Potential for Biosimilar Medicines, 1st March 2016. Available here
3 Drug appraisal. Assessing the efficacy and safety of Omnitrope, The British Journal of Clinical Pharmacy 2010; 2:298-301
4 GfK EGA Sustainability Study 2014 September 9, Pg. 36
5 AbrahamJ et al. Developing oncology biosimilars: an essential approach for the future. Semin Oncol 2013:40 (Suppl 1): S5-S24
6 Delivering on the Potential of Biosimilar Medicines The Role of Functioning Competitive Markets, IMS, March 2016. Available here
7 Improving efficiency and resource allocation in future cancer care, OHE, September 2016. Available here
8 Assessing biosimilar uptake and competition in European markets, IMS Institute for Healthcare Informatics, October 2014. Available here
9 Medicines Optimisation dashboard on infliximab. Available here
10 NHS England, Five Year Forward View, October 2014. Available here
11 NHS Digital, Statistics available here
12 IMS Health, MIDAS, MAT, Rx bound. Europe doesn’t include Russia and Turkey, June 2014
77%
1
We have a market in the UK where generic and biosimilar medicines fulfil nearly three-quarters of all prescriptions for conventional medicines.
Our team
Dr. Andrew Ellis
Chair of the British Biosimilars Association
Dr Andrew Ellis, Director of Secondary Care at Teva UK, is the chair of the BBA. Dr Ellis, a graduate from the University of Liverpool, began his career as a research scientist specialising in the development of agents to treat ischaemic heart disease. Since then, the vast majority of his career has focused on marketing and sales roles within the pharmaceuticals and medical devices sectors.
He joined Teva in 2007 as Marketing Manager for the Hospitals Business Unit and has also worked across branded (specialty) medicines in therapy areas ranging from oncology, pain, mental health, urology, immunotherapy, women’s health and neurology. His current role as Director of the Secondary Care business sees him focus on issues of market access, while leading the commercial and marketing teams.
Matthew EddlestonMatthew Eddleston
Vice Chair of the BBA
Matthew is the BBA’s vice-chair and commercial Director at Celltrion Healthcare UK Ltd. He was formerly Biosimilars Business Unit Lead at Fresenius Kabi. (UK & Ireland). Prior to that, he worked at Pfizer, where he was Biosimilars Regional Commercial Director, Northern Europe. Matthew’s first senior leadership role in Biosimilars began in 2014, as Hospira’s Head of Market Access, UK, Benelux and Ireland.
Matthew brings healthcare leadership over a 21-year career to date, working across key commercial roles in both the generic and pharma sectors. He established Fresenius Kabi’s Biosimilar Business Unit and previously implemented the market access strategy for the European launch of the World’s first Biosimilar monoclonal antibody.
Matthew graduated with a dual bachelors degree in International Business from Hull Business School and Auckland University, New Zealand.
Dr. Andrew EllisMark SamuelsMark Samuels
CEO
Mark is the Chief Executive of both the British Biosimilars Association (BBA), as well as its sister body the British Generic Manufacturers Association (BGMA). Mark’s career has spanned diverse experience across the life sciences sector. He is a former executive at Roche and co-founded the Medicines Discovery Catapult Ltd. He was the founding Managing Director of the government’s Office for Clinical Research Infrastructure – instrumental in managing the Department of Health’s £0.6 billion/year investment in research centres across the NHS. Mark served for seven years on the Chief Medical Officer for England’s strategy board for health research, and he has worked with Number 10 to contribute to the Prime Minister’s strategy for life sciences.
Matthew EddlestonJeremy DurrantJeremy Durrant
Communications Director
Jeremy Durrant heads up all internal and external communications activity on behalf of the British Biosimilars Association (BBA). He also is actively involved in stakeholder engagement, membership services, events and networking.
Mark SamuelsPaul FlemingPaul Fleming
Technical Director
Paul Fleming is Technical Director of the British Generic Manufacturers Association (BGMA) and the British Biosimilars Association (BBA). The roles include close and regular working with MHRA, Department of Health and Social Care, the NHS, UK Government and other stakeholders. At a European level, Paul is a member of the regulatory and quality committees of Medicines for Europe. In 2015 he wrote the Regulatory Efficiency Report for EGA, setting out a wide range of recommendations identifying opportunities for improvement within the regulatory system for generic medicines.. Paul has 15 years’ experience from working in the generic sector of the European pharmaceutical industry, in a variety of senior board level roles covering R&D, drug regulation, pharmacovigilance and clinical development. Earlier in his career Paul spent six years with the MHRA as a pharmaceutical assessor. He is a registered pharmacist and holds a higher degree in pharmaceutical technology. Throughout his professional life Paul has maintained an involvement with the science of pharmaceutical development connecting to how medicines can be used for the maximum benefit of patients and the NHS.
Jeremy DurrantAnia SwirskiAnia Swirski
Biosimilars Manager
Ania supports the BBA’s engagement with NHS England, NICE, MHRA and other relevant bodies and stakeholders to increase understanding of biosimilar medicines through information, guidance and partnership working.
Paul FlemingOur members
Disclosure
Medicines for Europe disclosure request
As a national association member of Medicines for Europe, BGMA asks its members to disclose certain in-kind or actual transfers of value that have been made over the previous year to healthcare professionals, healthcare institutions or patient organisations.
Some BGMA (and BBA) members already voluntarily disclose this information through their membership of other trade bodies; and so they do not need to report twice. Some BGMA members have chosen to post their disclosure record on their own website. And some members have opted to post their return on the BGMA website.
As such, BGMA confirms that the following companies have opted to make a disclosure return on the BGMA website:
| Company name | Reporting a nil return or a transfer in value? | Type of transfer of value | Explanation | Value or payment (£) | Total amount transfers of value (£) |
|---|---|---|---|---|---|
| Rivopharm UK Ltd | Nil return | NA | NA | NA | 0 |
| Bowmed Ibisqus Ltd | Transfer of value | Third party organised congress | NHS Pharmaceutical Quality Assurance & Technical Services Symposium | 225.00 | 225.00 |
| Aspire Pharma Limited | Transfer of value | Fees for service and consultancy to HCP | Professional services from HCP 1 | 32,424.00 | |
| Transfer of value | Fees for service and consultancy to HCP | Professional services from HCP 1 | 3,432.00 | ||
| Transfer of value | Fee to healthcare organisation | Attendance of event with company stand | 600.00 | ||
| Transfer of value | Fee to healthcare organisation | Attendance of event with company stand | 250.00 | ||
| Transfer of value | Fee to healthcare organisation | Attendance of event with company stand | 240.00 | 36,946.00 |