Over the past decade, biosimilar medicines have generated more than 400 million patient days of positive treatment experience mainly in areas such as endocrinology and supportive cancer care. With the European approvals of biosimilar infliximab and etanercept products, these treatment options are now available to treat more patients in rheumatology. A clear understanding of the underlying scientific principles of the biosimilarity concept is important for physicians to make informed choices for their patients and to increase access to highly innovative treatments.
Therefore, the Biosimilar Medicines Group, a Medicines for Europe sector group, organised today in London a satellite symposium on the science of extrapolation and interchangeability at the annual congress of the European League Against Rheumatism (EULAR). Several hundred rheumatologists had the opportunity to learn from renowned regulatory and clinical experts about the regulatory, scientific and the latest clinical knowledge regarding biosimilar medicines.
Ahead of the event, Adrian van den Hoven, Director General of Medicines for Europe highlighted that “the Biosimilar Medicines Group is engaging actively to reduce the information gap as an essential means to improving stakeholder trust, understanding and acceptance of biosimilar medicines, which are critical factors to increase patient access to medicines and to improve the efficiency and sustainability of healthcare systems.”
During the next two days, the key pharmaceutical industry leaders from the generic, biosimilar and value added medicines industries will meet in Dubrovnik to foster international partnership, cooperation and dialogue and discuss the most recent challenges of these industries for the future. With this year’s conference in Croatia, Medicines for Europe and the International Generic and Biosimilar Medicines Association (IGBA) celebrate their first joint event.
Amongst the key topics that will be tackled during the conference are the most important global challenges that the generic, biosimilar and value added medicines industries are facing today, such as the need to stimulate more competition in pharmaceutical markets, the trade and regulatory cooperation for better access, sustainable business models, improving the efficiency of healthcare systems and the stronger representation of the generic, biosimilar and value added industries in global fora regulating the pharmaceutical industry.
Jacek Glinka, Medicines for Europe President commented: “The impact of high cost new medicines on healthcare system sustainability is a concern for many healthcare policy-makers and advocacy groups. However, our industry is committed to delivering solutions that improve patient access to high quality medicines. We see this as an opportunity for our industry to provide leadership in the pharmaceutical market through an accessible innovation policy”.
Vivian Frittelli, IGBA Chair highlighted that “The majority of the world’s medicines in use today are generic medicines, while biosimilar medicines offer opportunities to treat millions more patients with biologic medicines and value added medicines are bringing sustainable innovation to all patients across the world”.
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 GPhA (USA), 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.org
· Value Added Medicines bring innovation throughout a molecule’s lifecycle to address patients’ health, improve the safety and efficiency of the work of healthcare professionals and increase physicians’ treatment options, while preserving the sustainability of the healthcare system.
· The Value Added Medicines Group seeks to work together with policy makers, payers, patients and healthcare professionals to address the barriers to this innovation so that all concerned stakeholders can take advantage of these opportunities.
A new study Value Added Medicines: Rethink, Reinvent & Optimise Medicines: Improving Patient Health and Access was launched today in Brussels by the Value Added Medicines Group, a sector group of Medicines for Europe. The report, conducted by Mondher Toumi, Professor of Public Health at Aix-Marseille University, identified several areas of healthcare inefficiencies in Europe and highlights new opportunities for innovation, health improvements and budget efficiency. Professor Mondher Toumi emphasised that “on average, 50% of patients do not take their medication as prescribed[1], which can have considerable consequences for their health and the healthcare system[2]. Value added medicines represent an opportunity to address a number of healthcare inefficiencies such as the suboptimal use of drugs, but also an opportunity to enhance healthcare system efficiency and contribute to the sustainability of healthcare systems.”
This was acknowledged by Christoph Stoller, Chair of the Value Added Medicines Group: “We need to move from responding to sickness towards improving well-being, keeping people healthy, looking ahead and thinking in the widest sense about care that is holistic, efficient and effective. The Value Added Medicines Group aims to rethink, reinvent and optimise medicines based on known molecules. It brings innovation throughout a molecule’s lifecycle to develop medicines which better understand patient needs and improve care delivery.”
While the majority of existing treatments deliver on their promises to a large number of patients, some may need to be adapted to match specific needs of the healthcare community. Since the discovery of these off-patent medicines more than 20 years ago, new scientific knowledge and new technologies have emerged, opening new research and development opportunities to address specific situations that could not be tackled 20 years ago.
The resulting value added medicines are medicines based on known molecules that address healthcare needs and deliver relevant improvement for patients, healthcare professionals and/or payers. Beyond improving patients’ quality of life and adherence, they can improve the safety and efficiency of the work of healthcare professionals, increase physicians’ treatment options and improve overall budget efficiency. Unfortunately, the current market environment in Europe does not allow the healthcare community to fully capture the benefits of value added medicines as the study has identified several obstacles for their uptake. While all stakeholders should recognise the benefits that value added medicines bring, HTA and pricing and reimbursement authorities should adapt their pathways so that their added value can be shown and rewarded appropriately. In return and with the right pathways, the industry needs to take a proactive approach and engage with authorities to assess how the evidence can be generated to support their claims.
Christoph Stoller added: “Delivering better outcomes will be lost if the healthcare community does not acknowledge and reward incremental innovation in the off-patent segment. Policy makers, payers, patients, healthcare professionals and our sector group need to work together to address the barriers highlighted in the study so that all concerned stakeholders can take advantage of this innovation”.
Supporting documents
[1] Sabaté E. Adherence to long-term therapies. Evidence for action. World Health Organisation (WHO). 2003. [Internet]. Available from: http://apps.who.int/iris/bitstream/10665/42682/1/9241545992.pdf (Cited 2016 May 09)
[2] Kelly M, McCarthy S, Sahm LJ. Knowledge, attitudes and beliefs of patients and carers regarding medication adherence: a review of qualitative literature. IJPP 2015, Supplement 1: 28–49. (Original reference: European Council Policy Makers Debate. An EU response to medication non-adherence. Brussels, 2010)
Medicines for Europe stands ready to contribute to the work of Fight the Fakes in educating and informing people about the public health risk posed by fake medicines.
Medicines for Europe, the voice of the generic, biosimilar and value added medicines in Europe, is proud to announce its partnership in the Fight the Fakes campaign. By joining this initiative, Medicines for Europe acknowledges the magnitude of the problem related to the existence of fake medicines. Fake medicines can be branded or generic, prescription or over-the-counter medicines. They are a threat to patient safety as they will not treat illness and can worsen a patient’s condition, potentially leading to further illness, disability and even death.
Public awareness of the issues related to medicine counterfeiting is fundamental and Medicines for Europe is ready to contribute to Fight the Fakes in educating and informing the public about these risks. Fake medicines represent a serious public health threat, since their quality and safety cannot be proved. Medicines for Europe joins over 30 partner organisations from across the world who will collaborate in raising awareness of fake medicines as part of the Fight the Fakes campaign. This new partnership is being launched today, at the 69th World Health Assembly in Geneva, where Fight the Fakes is participating in an event on the importance of empowering people in the fight against fake medicines.
Adrian van den Hoven, Medicines for Europe Director General highlighted that “Fake medicines are illegal and dangerous. Fight the Fakes represents a great opportunity for a multi-stakeholder and multi-disciplinary collaboration”.
Medicines for Europe (formerly EGA) 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.
Fight the Fakes is a campaign that aims to raise awareness about the dangers of fake medicines. The campaign gives a voice to those who have been personally impacted and shares the stories of those working to put a stop to this threat to public health. It seeks to build a global movement of organisations and individuals who will shine a light on the negative impact that fake medicines have on people around the globe and aim to reduce the negative consequences on individuals worldwide. Fight the Fakes partners endorse the campaign and share the belief that coordination among all actors involved in the manufacturing and distribution of medicines is vital to tackle this public health threat. A Joint Statement signed by all partners is available at www.fightthefakes.org. Follow the campaign @FightTheFakes.
Fight the Fakes campaign communications: Cyntia Genolet c.genolet@fightthefakes.org
Medicines for Europe, the voice of the generic, biosimilar and added value medicine industries, applauds the adoption of the European Parliament’s report on the Single Market Strategy in Plenary. In their report, Members of the Parliament urged the European Commission to introduce and implement before 2019 an SPC (Supplementary Protection Certificate) manufacturing waiver to boost the competitiveness of the European generic and biosimilar medicines industries in a highly competitive global environment which will create additional jobs and growth in the EU.
The export of generic and biosimilar medicines to unprotected markets during the SPC period will stimulate investment in Europe, support the creation of highly skilled jobs and increase access to high quality medicines in third countries, without changing the equilibrium between the originator and the generic & biosimilar medicines industries in the EU.
“The European Parliament’s strong support for the creation of pharmaceutical manufacturing jobs in Europe through an SPC manufacturing waiver is clear” said Adrian van den Hoven, Medicines for Europe Director General. “This is the third time that the Parliament calls for the manufacturing waiver, now we expect the Commission to quickly introduce this strong trade stimulus to spur high-tech job creation and economic growth in Europe”.
For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.
Biosimilar medicines provide an opportunity to increase patient access to high quality treatments and to improve the efficiency of healthcare systems worldwide, as demonstrated in the white paper Delivering on the Potential of Biosimilar Medicines: the Role of Functioning Competitive Markets[1]. Over 50 new products in clinical development are expected to increase access to medicines through price competition across Europe and the US through 2020, provided appropriate policy measures in support of biosimilar medicines uptake are put in place, including clear statements by regulatory agencies on interchangeability, more information to patients and prescribers on the benefits and the underlying science of biosimilar medicines and policy incentives for hospitals and prescribers to use more biosimilar medicines. Since their first introduction in the EU, biosimilar medicines increased patient access by 44% in the EU-5 countries between 2006 and 2014[2].
“Biosimilar medicines have the potential to dramatically increase patient access and generate savings for healthcare systems” said Carol Lynch, Global Head of Biopharmaceuticals at Sandoz and Chair of the Biosimilar Medicines Group, a Medicines for Europe sector group. “The Biosimilar Medicines Group is engaged in fostering multi-stakeholder dialogue as an essential means to improving stakeholders’ trust, understanding and acceptance – a critical factor in ensuring uptake for these important products”.
Ahead of the event, Jacek Glinka, President of Medicines for Europe, highlighted that the industry stands ready to work with Member States to increase patient access to biological treatments and reduce health access inequalities across Europe. Glinka called on Member States “to take full advantage of the introduction of biosimilar medicines and devise policies aimed at reducing the disparities in access. Europe has been a leader and an inspiration in setting the scientific framework, let’s continue and have Europe lead in the development of sustainable access policies.”
During the 14th Annual Biosimilar Medicines Group Conference, taking place today and tomorrow in London, the Biosimilar Medicines Group will gather the world’s experts in the field to look back at the 10 year success story of European biosimilar medicines and engage with stakeholders in mapping opportunities for the sector to deliver on the promise of access. Discussions will cover recent market developments and access policies as well as international regulatory convergence and regulatory science, with the involvement of regulators from the EU (EMA and BMWP), US (FDA), Korea (MFSD) and Japan (PMDA).
Biosimilar Medicines Handbook – 3rd Edition
[1] IMS Institute for Healthcare Informatics, March 2016
[2] IMS Midas 2014
Launched on 28 October 2015 , the European Commission’s new strategy ‘A Single Market Strategy for Europe – Analysis and Evidence’ proposes a manufacturing waiver during the SPC period to allow the EU generic and biosimilar medicines industries to create up to 64.000 high-tech jobs in the EU and dozens of new companies, with a €3.3 billion business value[1]. The measure would also bring pharmaceutical R&D back to Europe as R&D and manufacturing are often conducted on the same sites for pharmaceuticals. The export of generic and biosimilar medicines to non-EU countries during the SPC period will increase access to high quality medicines in third countries without changing the equilibrium between the originator and the generic & biosimilar medicines industries in the EU.Today the Committee on Internal Market and Consumer Protection (IMCO) of the European Parliament adopted its report on the “Single Market Strategy” calling on the Commission to stimulate manufacturing and early export of generic and biosimilar medicines to countries where no patent or supplementary protection certificates (SPC) exist.
Adrian van den Hoven, Medicines for Europe Director General commented: “The Parliament has once again voted for more manufacturing jobs for Europe by calling for an SPC manufacturing waiver. The Commission should now move forward without delay to make a formal legal proposal to deliver on this tremendous development opportunity for the European pharmaceutical manufacturing industry”.
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
[1] Vanda Vicente and Sergio Simoes, 2014, Manufacturing and export provisions: Impact on the competitiveness of European pharmaceutical manufacturers and on the creation of jobs in Europe.