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”.
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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.
Medicines for Europe and its Biosimilar Medicines Group took note of the EuropaBio paper on physician preference regarding biosimilar labels (SmPC)[2] which attempts to create an unnecessary differentiation between biosimilar medicines and their reference products, despite the stringent science-based EU approval process guaranteeing full comparability in efficacy and safety. Biosimilar medicines are assessed and authorised based on a head-to head comparison and the ‘totality of evidence’ available, which includes the experience and knowledge gathered for the originator medicine and well captured in the ‘same label’ approach, which is consistent with the EU legal, scientific and regulatory framework, as well as the current practice for all medicines in case of a line extension or following manufacturing changes.
Regrettably, the second part of the paper fails to acknowledge some fundamental elements such as the existing consensus on the need to improve accessibility and suitability of the information on all medicines for both Healthcare Professionals and Patient Communities, beyond the sole product information. The availability of unbiased information from regulatory agencies is typically not an issue thanks to transparent policies where, for example, anyone can access the European Public Assessment Report for any centrally authorised medicine on the EMA website.
According to Adrian van den Hoven, Director General Medicines for Europe, “our Biosimilar Medicines Group is engaged in many multi-stakeholder platforms to facilitate the accessibility and understanding of the information”.
See the Annex document with the full position
[1] Physicians prefer greater detail in the biosimilar label (SmPC) – Results of a survey across seven European countries, A.Hallersten et. al, http://www.sciencedirect.com/science/article/pii/S0273230016300654
[2] Physicians prefer greater detail in the biosimilar label (SmPC) – Results of a survey across seven European countries, A.Hallersten et. al, http://www.sciencedirect.com/science/article/pii/S0273230016300654
Over 100 participants will explore different ways and opportunities to ensure universal access to healthcare, together with members of the European Parliament (MEPs) and healthcare stakeholders. We have jointly agreed that this issue should be a priority on the European political agenda.
“We have now a great opportunity to accelerate our work to date through the Patient Access Partnership and the Riga Roadmap, by also collaborating on the actions needed now to ensure the sustainable development goal on universal access becomes reality by 2030”. Nicola Bedlington, EPF Secretary General.
“Exchange of information and collaboration among the different stakeholders is indispensable to improve access to healthcare. The treatments must not only be available, they also have to be affordable. The annual meetings among the different actors in healthcare are a first step to foster dialogue in order to guarantee high quality health services for everybody”. Menno Aarnout, AIM Executive Director.
“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.
Better access to medicines leads to better health. For this reason, the EU needs 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.
Speaking ahead of the event, Adrian van den Hoven, Medicines for Europe Director General, commented that “cooperation among stakeholders is key to improve access to healthcare in Europe. This annual gathering is a great opportunity to build a partnership with stakeholders to deliver access to high quality healthcare, including medicines to patients, while ensuring the sustainability of our systems”.
Medicines for Europe, EPF, EPHA and AIM are looking forward to further progress and milestones promoting better access for better health and to meeting in 2017 for the 4th Edition.
Biosimilar medicines represent an essential opportunity to optimise patient access to high quality treatments and the efficiency of healthcare systems worldwide, according to the white paper “Delivering on the Potential of Biosimilar Medicines: The Role of Functioning Competitive Markets”, published by the IMS Institute for Healthcare Informatics this week. Some 50 new products in clinical development are expected to increase access to medicines through price competition across Europe and the US through 2020.
The white paper highlights the extraordinary contribution of biosimilar medicines to the growing demand of patients to access effective gold standard biological therapies and to address the sustainability of healthcare budgets. The white paper advocates for rapid biosimilar medicines uptake and for a sustainable biosimilar market environment, underlining that patient access to biologic treatments has grown by as much as 100 percent following the availability of biosimilar medicines. In order to maximise the benefits of biosimilars, the report says that acceptance of biosimilar medicines is the largest contributor to success.
Medicines for Europe Director General, Adrian van den Hoven, welcomed the IMS Institute for Healthcare Informatics publication: “This white paper confirms the efforts made by biosimilar manufacturers to invest strongly in better access for patients and more sustainability to pharmaceutical markets across the world. With more than 10 years of positive patient treatment experience and some 20 products successfully launched in Europe, biosimilar medicines provide a huge opportunity today to deliver significantly improved access to modern therapies for millions of European patients in both chronic and acute care in areas such as cancer, diabetes, rheumatoid arthritis or other immune-related diseases. Biosimilar medicines answer one of Europe’s major healthcare challenges: how to ensure that all European patients get equitable access to treatment”.
The European Generic and Biosimilar Medicines Association is now Medicines for Europe Better access. Better health. Generic medicines are now the cornerstone of European healthcare, the Biosimilar medicines sector is developing rapidly, and the need and opportunity for Value Added medicines will further transform healthcare. Our industries supply the majority of Europe’s prescription medicines which is estimated to grow from the current 56% to 75% in volume over the next 5 years, as the demand for access to high quality medicines for European patients has never been greater. The repositioning of our association as Medicines for Europe aims to drive greater healthcare efficiency through better health outcomes while providing solutions for the sustainability of European healthcare systems facing increased demographic demands on healthcare services.
“Medicines for Europe Better access. Better health reflects our industries’ purpose and strategic objectives,” said Medicines for Europe President Jacek Glinka. “As an organisation we have been through an incredible journey responding to the changes that have taken place in the pharmaceutical industry and European healthcare environment. I invite stakeholders and policy-makers to engage with us to deliver access to high quality medicines for all European patients.”
Adrian van den Hoven, Medicines for Europe Director General, added: “Medicines for Europe is a great opportunity to build on the EGA’s established reputation for partnership with stakeholders and authorities to deliver access to high quality medicines for patients, its commitment to the highest levels of quality, and to bringing even more value to pharmaceuticals while bridging the sustainability of healthcare with a competitive pharmaceutical manufacturing industry.”
Last week in Brussels, the European Biosimilar medicines Group (EBG – a sector group of the EGA) elected its new leadership team with Sandoz’ Carol Lynch as Chair of the overall sector group and Polpharma’s Klaus Martin, Chair of the market access group of the EBG.
Carol Lynch is Global Head of Biopharmaceuticals and Oncology Injectables at Sandoz. Lynch has more than 25 years of global pharmaceutical and generics industry experience. Prior to joining Sandoz in 2014, Lynch held several Commercial and Development leadership positions at Novartis Pharmaceuticals both globally and in country organizations, including the United States. She is a member of the Sandoz Executive Committee.
In her new role as Chair of the EBG Group, Carol Lynch highlighted: “The EBG is the leading group in Europe for the biosimilars industry and as the newly elected Chair, I look forward to representing the EBG during what will be another important two years. With fellow EBG members, we will support the expansion of patient access to high-quality biosimilar medicines, while ensuring the sustainability of our industry in Europe and beyond”. Ildiko Aradi, Gedeon Richter, and Karl Heinz Emmert, Teva, were re-elected as Vice-chairs of the EBG.
Klaus Martin is Senior Director at Polpharma Biologics and Chief Science officer, leading global late-stage development, portfolio management and strategic marketing and medical affairs. Klaus has been working on biosimilar medicines since 2002. He has held global management positions at Sandoz Biopharmaceuticals and has been an active member of the EBG since Polpharma joined the EGA in 2014.
As the new Market Access Group Chair, Klaus Martin commented that “Biosimilar medicines are increasingly embraced by markets as an important means to provide better access for patients to better healthcare. However, there are still many barriers to patient access to biosimilar medicines which the EBG will work hard to remove over the next two years”. Dan Ionescu, Sandoz, was appointed Vice-chair of the Market Access Group.
EGA Director General, Adrian van den Hoven, welcomed the new leadership team which will continue leading the way on transforming healthcare, improving access to more safe high quality treatment options for physicians and their patients.
About the EBG and the EGA
The European Biosimilars Group (EBG), a sector group of the EGA, represents the leading companies in the biosimilar medicines space. The EBG Members bring competition to the biologicals 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.
The EGA represents the European generic, biosimilar and value-added medicines industries, which provide high-quality cost-competitive medicines to millions of European patients. Companies represented within the EGA provide over 160,000 skilled, high value direct jobs in Europe. Without generic medicines, payers in Europe would have had to pay €100 BN more in 2014. Generic medicines account for 56% of all dispensed medicines but for only 22% of the pharmaceutical expenditure in Europe. The European generic, biosimilar and value-added medicines industries’ vision is to provide sustainable access to high quality medicines for all European patients, based on 5 important pillars: patients, quality, value, sustainability and partnership. For more information please visit: www.egagenerics.com and follow EGA and EBG on Twitter at:@egagenerics and @ebgbiosimilars.