The new report on The Impact of Biosimilar Competition in Europe highlights the visible benefits of biosimilar competition to increase patient access to highly innovative biological treatments. The new report was prepared by QuintilesIMS Health at the request of the European Commission with contributions from EFPIA, EuropaBio and Medicines for Europe.
Despite differences between countries, the overall trend in Europe is that biosimilar medicines are increasingly being used in medical practice and are increasing access to medicines for patients. Biosimilar competition in this high value market contributes to sustainable healthcare budgets. For many countries, especially in Eastern Europe, biosimilar medicines provide access to patients where it had previously been denied.
The QuintilesIMS report also highlights the need for multiple biosimilar players in the market to take advantage of the full benefits of competition in the long-run, which is in line with earlier findings[1]. Governments should refrain from pursuing drastic short-term policies that limit the number of competitors in the market. Aligning payers’ and manufacturers’ understanding of the short, medium and long term benefits of biosimilar medicines is a cornerstone of sustainable biosimilar policy-making and healthcare sustainability. In addition and as highlighted during the event organised by the European Commission last week in Brussels[2], the availability of information and education around the use of biosimilar medicines is important to build stakeholder confidence in biosimilar medicines. Evidence-based discussions in a multi-stakeholder setting have largely contributed to the success of gainsharing schemes thanks to which biosimilar medicines have been introduced in medical practice across Europe for better access.
Adrian van den Hoven, Director General Medicines for Europe, commented: “Biosimilar medicines form an essential part of healthcare provision in Europe today. They have brought and will continue bringing competition to the market, providing access to biological therapies that are out of reach for too many patients in Europe. Medicines for Europe acknowledges the role of the European Commission and its partnership with QuintilesIMS in pursuing the dialogue and close monitoring of the unfolding of the competition in the biologics market”.
[1] Simon Kucher & Partners, Payer’s price and market access policies supporting a sustainable biosimilars market
[2] https://www.medicinesforeurope.com/news/industry-welcomes-the-3rd-european-commission-workshop-on-biosimilar-medicines/
The European pharmaceutical industry welcomes the 3rd workshop on access to biosimilars, organised today by the European Commission Directorate General for the Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) on access to biosimilar medicines in Europe. The event brought together patients, doctors, pharmacists, academics, authorities, press and industry to share experiences with biosimilar medicines across Europe.
The event has provided a great platform for information sharing on topics such as the importance of collaboration in encouraging the use of biosimilar medicines and building stakeholder confidence in biosimilar medicines through evidence-based information sharing.
In addition, following the successful launch of a Q&A for patients on biosimilar medicines at the end of 2016, the European Commission and EMA have jointly introduced an information guide for healthcare professionals. This document provides reliable information for EU healthcare professionals with reference information on the science and regulation underpinning the use of biological medicines, including biosimilars.
The European pharmaceutical industry fully supports the increased competition in the biologics markets and its contribution to the sustainability of healthcare systems and commends the European Commission which has contributed to the acceptance of and trust in biosimilar medicines in Europe. The broad range of stakeholders that attended the event from across Europe reflects the increasing interest and relevance of biosimilar medicines.
About the issuers of this press release
The industry is represented by the European Federation of Pharmaceutical Industries, and Associations (EFPIA), the European Association for Bioindustries (EuropaBio) and Medicines for Europe-Biosimilar Medicines Group.
For further information, please contact:
EFPIA: Communications Team, +32 2626 2555, communications@efpia.eu
EuropaBio: Cosmin Popa, +32 2 739 11 73, c.popa@europabio.org
Medicines for Europe: Doris Casares, +32 2 533 98 18, doris@medicinesforeurope.com
About EFPIA
The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. Through its direct membership of 33 national associations and 39 leading pharmaceutical companies, EFPIA is the voice on the EU scene of 1,900 companies committed to researching, developing and bringing to patients new medicines that will improve health and the quality of life around the world.
About EuropaBio
EuropaBio, the European Association for Bioindustries, promotes an innovative and dynamic European biotechnology industry. EuropaBio and its members are committed to the socially responsible use of biotechnology to improve quality of life, to prevent, diagnose, treat and cure diseases, to improve the quality and quantity of food and feedstuffs and to move towards a biobased and zero-waste economy. EuropaBio represents 77 corporate and associate members and bio regions, and 16 national biotechnology associations in turn representing over 1800 biotech SMEs.
Read more about our work at www.europabio.org.
About Medicines for Europe – Biosimilar Medicines Group
Medicines for Europe represents the generic, biosimilar and value added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members employ 160,000 people at over 350 manufacturing and R&D sites in Europe, and invest up to 17% of their turnover in medical innovation.
The Biosimilar Medicines Group is a sector group of Medicines for Europe and represents the leading companies developing, manufacturing and marketing biosimilar medicines across Europe. Our members bring competition to the biologic medicines market, thereby increasing access to highly innovative medical treatments to patients in Europe and around the world, and supporting the sustainability of the European healthcare systems.
Over 100 participants explored different ways and opportunities to ensure universal access to healthcare, together with members of the European Parliament (MEPs) and healthcare stakeholders during the Universal Access to Health event that took place today in Brussels. At this year’s event, Medicines for Europe, the European Patients’ Forum (EPF), the European Public Health Alliance (EPHA) and the European Social Insurance Platform (ESIP) joined forces to explore ways to improve access to healthcare.
“This meeting offers a great opportunity to strengthen our work to date, through partnership with all relevant stakeholders supporting the current initiatives towards the achievement of the UN Sustainable Development Goal on Health, to ensure universal access and health coverage for all by 2030”. Nicola Bedlington, EPF Secretary General.
“The engagement of all stakeholders in pursuing the goal of universal access to healthcare is essential. Fundamental to this goal is the need to ensure the sustainability of healthcare systems and that of the social health insurances. In this respect, medical treatments must not only be available and affordable, they must also respect quality, efficacy and patient safety requirements”. Arnaud Emeriau, ESIP President.
“The access to medicines debate is a social justice issue in Europe today. We need a comprehensive dialogue on all issues with a balanced involvement of all stakeholders”. Yannis Natsis, EPHA Policy Coordinator for Universal Access & Affordable Medicines.
Speaking ahead of the event, Adrian van den Hoven, Medicines for Europe Director General, commented that “Medicines for Europe calls on the EU to stimulate competition in pharmaceutical markets post-patent where generic and biosimilar medicines have demonstrated their ability to massively increase access to medicines without raising the overall treatment costs, and where value added medicines can play a fundamental role to improve treatments and health outcomes”.
Medicines for Europe, EPF, ESIP and EPHA are looking forward to further progress and milestones promoting better access for better health and to meeting again in 2018 for the 5th Edition of Universal Access to Health.
Medicines for Europe represents the generic, biosimilar and value added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members employ 160,000 people at over 350 manufacturing and R&D sites in Europe, and invest up to 17% of their turnover in medical innovation. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.
Medicines for Europe Communications: Doris Casares doris@medicinesforeurope.com
/Andrea Bedorin abedorin@medicinesforeurope.com Phone: +32 (0)2 533 98 10
+++++++
EPF currently represents 74 members, which are national coalitions of patient’ organisations and disease-specific patient organisations working at European level. EPF reflects the voice of an estimated 150 million patients affected by various chronic diseases throughout Europe. EPF’s vision is that all patients with chronic and/or lifelong conditions in the EU have access to high quality, patient-centred equitable health and social care. The EPF strategic goals focus on areas such as health literacy, healthcare design and delivery, patient involvement, patient empowerment, sustainable patients’ organisations and non-discrimination. More information: www.eu-patient.eu
EPF Communications: Mr. Laurent Louette laurent.louette@eu-patient.eu Phone: +32 (0)2 280 23 35
+++++++
The European Social Insurance Platform (ESIP) represents over 40 national statutory social insurance organisations (covering approximately 240 million citizens) in 15 EU Member States and Switzerland, active in the field of health insurance, pensions, occupational disease and accident insurance, disability and rehabilitation, family benefits and unemployment insurance. The aims of ESIP and its members are to preserve high profile social security for Europe, to reinforce solidarity-based social insurance systems and to maintain European social protection quality. ESIP builds strategic alliances for developing common positions to influence the European debate and is a consultation forum for the European institutions and other multinational bodies active in the field of social security. For more information on our activities, go to www.esip.eu and follow us on Twitter @ESIP_EU
ESIP Communications: Christine Dawson chris.dawson@esip.eu Phone: +32 (0)2 282 05 62
+++++++
The European Public Health Alliance (EPHA) is a change agent advocating for better health. We are a dynamic member-led organisation, made up of public health NGOs, patient groups, health professionals, and disease groups working together to improve health and strengthen the voice of public health in Europe. EPHA is a member of, among others, the Social Platform, the Health and Environment Alliance (HEAL), and the Better Regulation Watchdog and SDG Watch Europe. http://www.epha.org
EPHA Communications: Giulia Vettore giulia@epha.org
The Value Added Medicines Group Participated for the First Time at the 22nd Congress of the European Association of Hospital Pharmacists Which Took Place 22-24 March in Cannes.
A special satellite symposium was organized on “Value added medicines – What value repurposed medicines might bring to hospital pharmacists”. Christoph Stoller, chair of the Value Added Medicines Group, chaired the session and opened with a short introduction to value added medicines. Professor Doctor Stephan Krähenbuhl, from the University Hospital of Basel, explained to the audience the importance of continuous innovation on existing molecules for the physician perspective. He presented several examples of repurposed medicines which benefited him in his work. Minodora Voiculescu, Medical Advisor at Fresenius Kabi, closed the presentations by focussing on the existing barriers for value added medicines in Europe and how hospital pharmacists can ensure their availability.
With 10 years of positive experience with biosimilar medicines, medical societies and regulators across Europe have now adopted clear guidance in support of biosimilar medicines use and in physician-led switching from reference to biosimilar medicine. Biosimilar medicines are an essential part of healthcare provision in Europe today in the therapeutic areas where they have been authorised.
Carol Lynch, Global Head of Biopharmaceuticals at Sandoz and Chair of the Biosimilar Medicines Group at Medicines for Europe, commented today: “With the imminent arrival of a new wave of biosimilar medicines, we need to build upon our 10 years of experience with successful biosimilar medicines use. We know that education and sharing benefits among stakeholders are key drivers to improve access and treatment for patients. The Biosimilar Medicines Group encourages stakeholders to take an active role in creating a biosimilar sustainable environment to deliver better access to biologics for the patients of tomorrow”.
Biosimilar medicines provide an outstanding opportunity to improve access to essential, life-saving medicines in a way that is sustainable for healthcare systems, as exemplified at the 15th Biosimilar Medicines Conference in London. The biosimilar medicines portfolio is set to expand to the Top 10 medicines having the highest impact on healthcare budgets1, among which several target oncology therapies. The first of these was the EU approval for a biosimilar medicine – rituximab – as a first line indication in oncology in February of this year. This opens up new frontiers for better access, better health.
Healthcare spending continues to grow, with global spending on medicines for cancer care having reached the $100 billion threshold already in 2014[2]. Disparities in access to cancer medicines vary widely among countries. This trend is likely to continue due to demographic and other factors increasing cancer incidence among the EU population.
Biosimilar medicines are now widely used in medical practice, bringing competition to the market, further increasing patient access to biological therapies and other needed health services. In an era of tight and pressured healthcare budgets, the benefits of biosimilar medicines cannot be ignored.
Jacek Glinka, Medicines for Europe President, highlighted that “Biosimilar medicines are a real game changer for better health. Stakeholders have a shared responsibility to ensure timely availability of biosimilar medicines to improve patient access to biological therapies and the sustainability of national healthcare systems.”
[1] IMS Health, MIDAS 2016
[2]IMS Institute for Healthcare Informatics, 07 October 2015 – http://www.imshealth.com/en/thought-leadership/quintilesims-institute/reports/ims-health-finds-global-cancer-drug-spending-crossed-$100-billion-threshold-in-2014-article
Key authorities, eminent lawyers and industry leaders discussed today in London the proposals put forward by the European Commission to stimulate jobs and growth in the pharmaceutical sector in Europe at the Medicines for Europe 13th Legal Affairs Conference. The high level participation at the event was crucial to advance discussions on key legal and IP topics impacting the generic, biosimilar and value added medicines industries.
This year’s conference addressed fundamental issues such as the consequences of the EU Health Council Conclusions of June 2016 calling for a review of pharmaceutical incentives, the impact of Brexit on the industry, antitrust developments, SPC case law, as well as interactive roundtables on the Unified Patent Court, orphan drugs, second medical use patents, clinical trial transparency, grace periods, the industry Code of Conduct, compulsory licenses, the Falsified Medicines Directive, EPO developments and data protection. The Commission proposal for an SPC manufacturing waiver for pharmaceutical production and R&D in Europe and to foster high-skill job creation and economic growth was discussed in depth.
“Today’s conference provides pathways to encourage competition, innovation and growth in the pharmaceutical sector. Patients, governments and healthcare systems rely on a strong generic, biosimilar and value added medicines industry to increase access to medicines and to create jobs for Europe”, commented Sergio Napolitano, Legal Affairs Director at Medicines for Europe, speaking ahead of the 13th Legal Affairs Conference, “an adapted legal environment that includes the SPC manufacturing waiver will boost investments in our sector and we stand ready to support job creation measures”.
On 9th March, IFPMA launched jointly with EFPIA and EBE a position paper entitled Considerations for physicians on switching decisions regarding biosimilars. Physician-led switching of biological medicines is a well-known medical practice. Although data on the frequency of switching in clinical practice is scarce, no evidence from clinical trials or post marketing surveillance data has found that switching to or from different biotherapeutics leads to safety concerns[2].
Given the fact that, from the regulatory and scientific viewpoints, a biosimilar medicine is a biological medicine containing a highly similar version of the same active substance as its reference product and also that the medical community is keen to express its social responsibility as well as support increased access to biological treatments, it is consequently surprising that the encouragement of physicians to switch from an original biological product to any of its biosimilar products (or vice-versa) is challenged.
It is also surprising from a scientific perspective: biological product manufacturers make frequent changes to manufacturing processes both during development and after approval which leads to highly similar versions of the same product over time, after having performed a thorough comparability exercise. This approach is outlined in the ICH guideline Q5E: “The demonstration of comparability does not necessarily mean that the quality attributes of the pre-change and post-change product are identical, but that they are highly similar and that the existing knowledge is sufficiently predictive to ensure that any differences in quality attributes have no adverse impact upon safety or efficacy of the drug product.”[3]
These scientific principles have been used successfully by industry and regulators for several decades to ensure close similarity of a biological product before and after a manufacturing change, and have therefore formed the basis for establishing the concept of biosimilarity. Furthermore, “when comparability has been demonstrated, the new version can be introduced to the market without informing prescribers, pharmacists, or patients.”1
We consequently call upon all stakeholders to maintain trust in our medical communities and regulators in the context of biosimilar medicines and in particular in their risk evaluation of a switch from a reference medicine to a biosimilar medicine or vice-versa. EU regulators, who have the longest global experience with biosimilar medicines use (over 10 years) concluded recently that “a switch between comparable versions of the same active substance approved in accordance with EU legislation is not expected to trigger or enhance immunogenicity”1, and that “switching patients from the original to a biosimilar medicine or vice versa can be considered safe”1 Physician-led switching is indeed fundamental for unlocking the full potential of biosimilar medicines and is supported by regulators and medical societies throughout Europe.[4]
Adrian van den Hoven, Chair of the International Generic and Biosimilar Medicines Association (IGBA), commented “We trust that this positive 10 year European experience with biosimilar medicines gives hope to patients around the world that improved access to biological medicines is possible.”
About IGBA
The International Generic and Biosimilar Medicines Association (IGBA) was founded as IGPA (International Generic Pharmaceutical Alliance) in March 1997 to strengthen cooperation between associations representing manufacturers of generic medicines. Its membership includes Medicines for Europe (Europe), the CGPA (Canada), the AAM (Association for Accessible Medicines), the JAPM (Jordan), the NAPM (South Africa), the TGPA (Taiwan) and the JGA (Japan) while the associations from Australia (GBMA), Brazil (ProGenericos) and Mexico (AMEGI) are Associate Members. The IGBA is at the forefront of stimulating competitiveness and innovation in the pharmaceutical sector by providing high quality pro-competitive medicines to millions of patients around the world. Through its constituent member associations, the IGBA maintains constant dialogue with government authorities (including the European Commission for Europe) as well as with international institutions such as WTO, WIPO and WHO. More information: www.igbamedicines.com
[1] Kurki P, et al. Interchangeability of Biosimilars: A European Perspective. BioDrugs. 2017 Jan 24. doi: 10.1007/s40259-017-0210-0
[2] Hans C. Ebbers et al. The safety of switching between therapeutic proteins. Expert Opin. Biol. Ther.2012
[3] ICH Q5E COMPARABILITY OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS SUBJECT TO CHANGES IN THEIR MANUFACTURING PROCESS
[4] Overview of positions on physician-led-switching
Medicines for Europe welcomes the fact that EFPIA (supported by EBE and IFPMA) recognises in its recently released paper the well-established nature of physician-led switching for biological medicines. This medical practice is common place, way beyond the sole field of biosimilar medicines.
The three associations also acknowledge that the similarity between a biosimilar medicine and its reference product is so high that if the reference product is associated with loss of efficacy or a tolerability issue, then a switch to the biosimilar medicine would have exactly the same consequences. EU regulators have recently concluded that ‘On the basis of current knowledge, it is unlikely and very difficult to substantiate that two products, comparable on a population level, would have different safety of efficacy in individual patients upon a switch[1]’.
Biosimilar medicines form an essential part of healthcare provision in Europe today. They have brought and will continue bringing competition to the market, providing access to biological therapies which have been out of reach for too many patients in Europe. In an era of tight and pressured healthcare budgets, the benefits of biosimilar medicines cannot be ignored. Physician-led switching is fundamental for unlocking the full potential of biosimilar medicines and is supported by regulators and medical societies throughout Europe.
Regulators have assessed and authorised biologic medicines for 35 years and physicians have a long experience with switching patients on biological medicines. Medical Societies are issuing guidance supporting the introduction of biosimilar medicines[2]. Therefore we believe that the industry should stay strongly aligned behind the robustness of the regulatory science which has proved to be effective following 10 years of experience1.
Adrian van den Hoven, Director General Medicines for Europe, commented: “These are exciting times, new biosimilar medicines in oncology and immunology are around the corner, enabling patient access to key therapies and to support sustainability. This will be at the heart of the debate in our upcoming conference where stakeholders will discuss this opportunity for better healthcare.”
[1] Kurki P, et al. Interchangeability of Biosimilars: A European Perspective. BioDrugs. 2017 Jan 24. doi: 10.1007/s40259-017-0210-0
[2] Overview of position statements – https://www.medicinesforeurope.com/wp-content/uploads/2017/03/M-Biosimilars-Overview-of-positions-on-physician-led-switching.pdf
Today, the European Parliament voted on the report on ‘Options for improving access to medicines’ that places generic, biosimilar and value added medicines at the heart of the debate on access to medicines. Together with the June 2016 Council Conclusions, this report provides the Commission and the Member States with a clear mandate to encourage more competition from generic and biosimilar medicines, underlining that generic medicines are a cornerstone of European healthcare, and biosimilar medicines offer tremendous opportunity for access to biotherapies.
The report also recognises the innovation in the off-patent sector as it can be beneficial for patients and deliver added value (hence value added medicines). These types of medicines will help address major healthcare challenges such as delivering better adherence and quality of life as well as better safety and efficacy and their benefits should be assessed.
“We urge the Commission and Member States to take action to ensure that these proposals are translated into real support measures for generic, biosimilar and value added medicines, allowing all patients across Europe to get access to the treatment they need” commented Adrian van den Hoven, Medicines for Europe Director General.
MEPs are also reiterating the call on the European Commission to stimulate manufacturing and export of generic and biosimilar medicines to countries where no patent or Supplementary Protection Certificate (SPC) exists. A manufacturing waiver for generic and biosimilar medicines during the SPC period will increase access to high quality medicines in unprotected markets, without changing the equilibrium between the originator and the generic and biosimilar medicines industries in the EU.
Europe is the cradle of the manufacturing industry and has been at the forefront of industrial revolutions and technological innovations. The industry directly employs over 34 million people across all Member States, in supply chains comprising hundreds of thousands of SMEs and larger suppliers. It also indirectly accounts for millions of additional jobs in related sectors.
The European manufacturing industry has tremendous capacity for research and innovation, boasts a skilled workforce and has earned a global reputation for quality and sustainability. What it now needs is the swift and determined support of the European institutions and the Member States to create more jobs and growth in Europe.
The time has come to raise the alarm about the considerable challenges that we are all facing. Between 2000 and 2014, the share of manufacturing in total EU output fell from 18.8% to 15.3%, while 3.5 million manufacturing jobs were lost between 2008 and 2014. Meanwhile, countries around the world are putting industry at the very top of their political agendas. The “Make in India” strategy aims to ensure India is “the next manufacturing destination” and “Made in China 2025” seeks to turn China into the “leading manufacturing power”. The recent US shift towards “America First” will inevitably have a strong impact on their industrial policy.
At the beginning of his mandate, European Commission President Jean-Claude Juncker identified the reindustrialisation of Europe as one of his top priorities and confirmed the objective of increasing the share of industry in the European GDP to 20% by 2020. As we approach the preparation of the next Multiannual Financial Framework, it is vital for the European Commission to act and help the EU remain a competitive global industrial power playing in a fairer world market.
Therefore we, the European manufacturing industry, representing a diverse range of sectors, call on the European Commission to:
Member States and the European Parliament clearly stated their full support for a strong European industrial strategy via the European Council Conclusions calling to strengthen and modernise the EU’s industrial base (15 December 2016) and the Parliament Resolution on the need for a European reindustrialisation policy (5 October 2016).
We, the Signatories of this Joint Declaration, are ready to step up our cooperation with the European Commission, the European Parliament and the Competitiveness Council to define and implement this ambitious and coordinated European industrial strategy that will help safeguard the world leadership of European manufacturers and jobs in Europe.
See the full Joint Declaration for an ambitious EU industrial strategy