Today, the Environment, Public Health and Food Safety Committee (ENVI) voted on an initiative report that places generic, biosimilar and value added medicines at the heart of the debate on access to medicines, which is expected to be adopted in Plenary in March. The report underlines that generic medicines are a cornerstone of European healthcare, biosimilar medicines offer tremendous opportunity for access to biotherapies and that value added medicines can help to address major healthcare challenges such as compliance to treatment, polypharmacy or reducing medication errors in hospital.
The report confirms that the EU is serious about improving access to medicines for European patients. Together with the June 2016 Council Conclusions, this report provides the Commission with a clear mandate to encourage more competition from generic and biosimilar medicines and recognises the importance of assessing the worth of value added medicines. This should translate into concrete support measures for Member States to help remove barriers and stimulate uptake – for example in the EU Semester Country Specific Recommendations. “After many debates, the Parliament is aligning with the Council to make competition from generic, biosimilar and value added medicines a high priority in policies to support access to medicines. The Commission should now take action to ensure that these proposals are translated into real measures so that all patients across Europe get the access they need. ” commented Adrian van den Hoven, Medicines for Europe Director General.
MEPs are also calling on the European Commission to stimulate early export of generic and biosimilar medicines to countries where no patent or Supplementary Protection Certificate (SPC) exists. 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 and biosimilar medicines industries in the EU.
This week in London, Medicines for Europe gathers national authorities, regulators and industry leaders to discuss future challenges and opportunities in the regulatory environment of the generic medicines industry. Important topics such as the future model of patient treatment and care, the evolution of generic medicines, the use of modern technology to support patient needs (such as the e-leaflet and mobile apps) and the optimisation of regulatory operations will be discussed during the two-day conference.
The optimisation of regulatory operations, reflected in the HMA/ EMA and CMDh 2020 workplans, are an important milestone for regulators and the industry. The recently created ‘Regulatory Optimisation Group’ (ROG) offers a promising platform to find practical solutions for regulatory efficiency and operational excellence. Industry will support this optimisation process for the benefit of patients and all partners involved in or impacted by regulatory activities. Other topics related to the overview of the globalised pharmaceutical supply chain will be discussed to create synergy between the industry and authorities on ensuring data integrity.
Adrian van den Hoven, Medicines for Europe Director General commented: “This event provides an invaluable platform for all stakeholders to build a 21st century regulatory system that prioritises patient needs, enables regulatory agencies to use their limited resources efficiently and the industry to deliver better access for better health.”
National authorities, regulators, industry leaders and pharmacists gathered in London this week to discuss how to improve patient access to safe medicines with an effective pharmacovigilance policy. This 10th edition of our Medicines for Europe conference highlighted how, if steered appropriately, technology and social media could strengthen the pharmacovigilance system.
Participants also reviewed experience gained in the implementation of EU pharmacovigilance legislation and underlined the need to optimise the use of regulatory and industry resources by applying a risk based approach. The conference called for more efficient distribution of educational material to patients and healthcare professionals. Cooperation between Industry and regulators should ensure that changes to signal detection processes do not lead to unnecessary duplication of work on both sides.
Adrian van den Hoven, Medicines for Europe Director General commented: “10 years of close cooperation between industry and regulators has led to a vastly improved pharmacovigilance system for European patients and healthcare professionals. New IT tools now need to become a big part of our cooperation to build an even better system over the next decade”.
Today, the European Commission published a unique Q&A for patients with reliable information on biosimilar medicines. Stakeholders value these efforts to provide unbiased, scientifically correct and yet easy to understand information on biosimilar medicines through the Q&A on Biosimilar Medicines, now available in 7 EU languages.
This consensus information on biosimilar medicinal products was drafted for patients together with the European Medicines Agency (EMA), the European Commission and relevant stakeholders: the European Patients Forum (EPF), the European Federation of Crohn’s & Ulcerative Colitis Associations (EFCCA), the Standing Committee of European Doctors, European Federation of Pharmaceutical Industries and Associations (EFPIA), European Association for Bio-industries (EuropaBio) and Medicines for Europe.
Biological medicines (including biosimilar medicines) come from living organisms (cells) that have been modified using biotechnology. A biosimilar medicine is developed to be highly similar to an existing biological medicine and has the same biological activity. Biological medicines help treat or prevent many severe diseases including cancers, heart attacks, stroke, diabetes, and autoimmune diseases, such as rheumatoid arthritis, multiple sclerosis and inflammatory bowel disease. Biosimilar medicines have significant potential to create competition in the biological medicine market and provide broader affordable access to medicines for patients.
For the third year in a row, the European Commission will organise a multi-stakeholder workshop on biosimilar medicines 5 May 2017. This year, the focus will be on developing a Q&A for healthcare professionals.
About the Biosimilar Medicines Group
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.
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
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.
EFPIA Communications Team:
communications@efpia.eu; +32 2626 2555
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 75 corporate and associate members and bio regions, and 17 national biotechnology associations in turn representing over 1800 biotech SMEs.
Read more about our work at www.europabio.org.
EuropaBio Communications Team:
Cosmin Popa, c.popa@europabio.org, +32 2 739 11 73
Strategic Alliance Made Official Following Successful mid-December Pharma CMO Summit Event in Berlin
Princeton, NJ – Supply Chain Wizard (SCW) – a leading full-service global consulting firm specializing in serialization and traceability, supply chain strategy and operational transformation programs – has officially partnered with Medicines for Europe, which represents the generic, biosimilar and value-added medicines industries across Europe.
Held December 12 in Berlin, the co-hosted Pharma CMO Summit drew more than 100 pharmaceutical executives from 27 countries. The summit was formed to serve as a resource for European pharmaceutical manufacturers moving to incorporate serialization processes to meet approaching regulatory deadlines – 2017 & 2023 for the United States, 2019 for the European Union – the strategic alliance comes on the heels of a highly successful event of the same topic.
With Optel Vision as the main sponsor, additional pharma manufacturer sponsors such as Abbott, Teva, Mylan and Nordic Group, and leading third-party logistics and solution sponsors, the event was well represented by key players in the serialization space. With serialization and track & trace deadlines looming, all parties were eager to obtain valuable insights into the challenges and intricacies facing companies in both Europe and the United States. Key to the event’s success were the networking events that provided ample opportunity to exchange serialization advice and experiences with peers from around the world.
The event also showcased ways in which serialization can go beyond mere regulation compliance to provide opportunities for enhanced business practices through data analytics produced by such systems. In this fashion, regulations once deemed onerous are actually opening doors to smarter manufacturing and supply chain operations.
As for the new partnership between Supply Chain Wizard and Medicines for Europe, the alliance brings together an industry advocacy group with a leading serialization consultant, helping European manufacturers of generic, biosimilar and value-added medicines connect the dots between learning about pending regulations and actually meeting their requirements.
“Education about serialization and track & trace regulations will always be ongoing but, as deadlines approach, it is time to turn informed plans into actualized, real-world solutions,” said Evren Ozkaya, founder and CEO of Supply Chain Wizard.
“As a leading partner for better healthcare, the organization aims to increase the health and well-being of all Europeans, while also addressing the business needs of European pharmaceutical manufacturers,” said Adrian van den Hoven, Director General of Medicines for Europe. “Partnering with a serialization & supply chain expert as well-regarded as Supply Chain Wizard helps us better serve both of these audiences.”
About Supply Chain Wizard
Supply Chain Wizard, LLC, is a leading full-service global consulting firm specializing in serialization and traceability, as well as supply chain strategy and operational transformation programs. Dedicated to optimizing operations for growth, service and efficiency, Supply Chain Wizard offers strategic innovations in products and services targeting serialization and supply chain transformation initiatives, along with a team of expert consultants providing comprehensive support toward cost-effective compliance with serialization mandates and post-go-live operational support.
Supply Chain Wizard organizes serialization roundtables, summits and training programs throughout Europe, Asia Pacific and the United States, and runs frequent webinars to support clients with their regulatory and compliance challenges. Committed to helping clients maintain significant and sustainable performance improvements, Supply Chain Wizard guides customers to a more secure supply chain via the implementation of high return-on-investment initiatives.
Supply Chain Wizard is headquartered in Princeton, NJ, with additional offices in Germany, Netherlands, Turkey and India. For more information, please visit www.supplychainwizard.com.
Medicines for Europe and Pharmexcil today organised a Workshop on Global Pharmaceutical Operations in New Delhi, gathering key authorities, regulators and senior pharma executives from India and Europe for the first time. During the workshop, the conference participants debated on mutual reliance with regard to the effects of globalisation and the interplay of trust, regulation and business; how to create a universally acceptable quality culture in relation to GCP (Good Clinical Practice) and GMP (Good Manufacturing Practice) compliance and how to foster regulatory cooperation between the EU and India.
India and Europe are two major centres for pharmaceutical development, clinical development and manufacturing. There are opportunities to strengthen the global competitiveness of these two centres through cooperation. Close cooperation and trust between regulators and industry in both regions can support a positive environment for business cooperation based on mutual reliance. One of the tools through which this trust can be built is through regulatory collaboration and by partnering with stakeholders in the globalised market to ensure full understanding of the requirements of good practice.
Adrian van den Hoven, Medicines for Europe Director General commented: “The globalisation of the pharmaceutical industry operations has fuelled a debate internationally regarding opportunities, challenges related to regulation across the manufacturing supply chain. Medicines for Europe supports regulatory cooperation with our partners to ensure effective and efficient regulation for better access to high quality medicines for patients in India and in Europe”.
Medicines for Europe assessed the publication of the report ‘Health at a Glance 2016’ launched yesterday prepared by the OECD for the European Commission. The report acknowledges that the development of generic medicines markets increases efficiency in pharmaceutical spending, however it focusses on short term cost-containment rather than taking into account access to medicines and the long-term sustainability of healthcare. Generic cost-containment policies have had no significant impact on overall healthcare budgets as the expenditure for generic medicines is only 2-3%. On the other hand, as underlined by the German Pharma Dialogue, cost-containment measures such as tendering significantly increase the risk of medicines shortages that ultimately undermine patient health. The most extreme examples of medicines shortages in Europe are found in countries with unsustainable pharmaceutical pricing policies such as Romania, where the combination of external reference pricing, price linkage and clawback have led to the withdrawal of 2000 medicines and chronic shortages of inexpensive medicines.
Regrettably, the OECD report does not underline the importance of timely availability of generics and biosimilar medicines in order to facilitate patient access to pharmaceutical therapies and to improve the sustainability of national health systems , which would be in line with the Council conclusions and the ‘Joint Report on Health Care and Long-Term Care Systems & Fiscal Sustainability’. Aside from financially incentivising prescribers, pharmacists and patients, policies should be put in place to reduce time to market and to educate the population on the quality, safety and efficacy of generic medicines and their equivalence to originator medicines. Furthermore, it is important to emphasise the relevance of putting in place key policy measures to increase the use of biosimilar medicines which play a key role in increasing patient access and in the long-term sustainability of healthcare systems.
Adrian van den Hoven, Medicines for Europe Director General commented: “The State of Health in the EU cycle is an important platform to support health policies in EU countries. We encourage the Commission to focus on generic, biosimilar and value-added medicine policies that increase access to medicines for patients rather than short term and counterproductive cost containment measures. Our medicines are developed and manufactured to serve patient needs not austerity policies”.
Summit to Provide Insight into Cost-Effective Compliance with Track & Trace Mandates for Pharma Contract Organizations in Europe & U.S.
Princeton, NJ – Supply Chain Wizard – a leading full-service global consulting firm specializing in serialization and traceability, as well as supply chain strategy and operational transformation programs – is co-hosting the Pharma CMO Summit on December 12, 2016 at the Ramada Hotel Alexanderplatz in Berlin. Titled Preparing Pharmaceutical CMOs & CPOs for Cost-Effective Serialization Compliance, the event will bring together manufacturers, CMOs, CPOs, 3PLs and solution providers for a full day of education and networking around the theme of making real progress toward serialization compliance.
The event is co-hosted with Medicines for Europe (formerly European Generics Association), an organization serving as the voice of Europe’s generic, biosimilar and value-added medicines industries. The December 12 gathering is the latest iteration in a series of such summits initiated by Supply Chain Wizard. Pharmaceutical industry professionals can register for the conference by visiting www.pharmacmosummit.com.
The goal of the event is to address the serious challenges presented by upcoming global serialization mandates, especially those in Europe and the United States. The day-long event will feature keynote addresses on major topics in serialization, along with panel discussions, breakout networking and roundtable sessions. Speakers and workshops will provide manufacturers and CMOs with strategies, processes and tools to prepare for serialization compliance and integration.
The event’s esteemed roster of sponsors speaks to the summit’s overall heft: The list includes Abbott, Teva and other leading pharmaceutical manufacturers. Solution providers will share best IT and packaging technologies, processes and tools for streamlining and enhancing serialization implementation. In addition, the conference will present opportunities for hands-on serialization learning activities, and will stress the sharing of content and experience among participants – a concept often seen as challenging in a largely close-to-the-vest pharmaceutical culture.
Another highlight of the event – one in which Supply Chain Wizard is particularly well-versed – is the opportunities for enhanced business practices through data analytics offered by optimized serialization systems. It is, according to the company, an instance where regulations once deemed onerous are opening doors to smarter manufacturing and supply chain operations.
“The exchange of knowledge this event will facilitate is the cornerstone of its success,” said Evren Ozkaya, founder and CEO of Supply Chain Wizard. “By bringing together multiple perspectives, and sharing both successes and struggles, we are confident attendees will leave this conference with a better understanding of what is needed to assure compliance with looming serialization mandates, and to effectively utilize the resulting data these new processes and systems will provide.”
About Supply Chain Wizard
Supply Chain Wizard, LLC, is a leading full-service global consulting firm specializing in serialization and traceability, as well as supply chain strategy and operational transformation programs. Dedicated to optimizing operations for growth, service and efficiency, Supply Chain Wizard offers strategic innovations in products and services targeting serialization and supply chain transformation initiatives, along with a team of expert consultants providing comprehensive support toward cost-effective compliance with serialization mandates and post-go-live operational support.
Supply Chain Wizard organizes serialization roundtables, summits and training programs throughout Europe, Asia Pacific and the United States, and runs frequent webinars to support clients with their regulatory and compliance challenges. Committed to helping clients maintain significant and sustainable performance improvements, Supply Chain Wizard guides customers to a more secure supply chain via the implementation of high return-on-investment initiatives.
Supply Chain Wizard is headquartered in Princeton, NJ, with additional offices in Germany, Turkey and India. For more information, please visit www.supplychainwizard.com.
Today, the European Commission published a Q&A for patients on biosimilar medicines. This important document provides a unique information resource for patients and healthcare professionals in support of a better understanding of the key scientific aspects related to biosimilar medicines as an alternative therapeutic option, and its role in generating greater access to high quality treatments for all patients across Europe.
Further to the EC Consensus paper on Biosimilar Medicines (adopted in 2013), and responding to a need for patient-friendly and reliable information on biosimilar medicines, this new document comes as an extension of the joint stakeholder work achieved so far. The Q&A is written by and for patients and aims to provide answers to the most frequently asked questions regarding alternative therapeutic options. The Q&A consists of a joint stakeholder document developed with the support of Medicines for Europe, EFPIA, EuropaBio, EPF, CPME, the European Commission and the European Medicines Agency (EMA) to educate patients on biological medicines, including biosimilar medicines.
Adrian van den Hoven, Medicines for Europe Director General highlighted that: “The European Commission has once again shown its leadership in improving information for stakeholders with this Q&A for patients. Building trust is important to promote more access to biosimilar medicines. The expanding use of biosimilar medicines ensures an increased access to treatment for patients and encourages competition”. He added: “We strongly encourage the European Commission to continue fostering competition in the biologic market and the use of biosimilar medicines in the medical practice as a way to contribute to the sustainability of healthcare systems”.
Note: This Q&A is an initiative by the European Commission Directorate General for the Internal Market, Industry, Entrepreneurship and SMEs (DG Grow) on access to biosimilar medicines in Europe, in relation to the Corporate Responsibility Programme. It was developed by a joint stakeholder group: Medicines for Europe, EFPIA, EuropaBio, EPF, CPME, the European Commission and the European Medicines Agency (EMA).
Today at the United Gastro-Enterology (UEG) week in Vienna, the NOR-SWITCH results were presented highlighting that the physician-led switching between medicines containing the originator and biosimilar (CT-P13) versions of infliximab led to the absence of statistical difference in patient outcomes. This result is consistent with the fact that biosimilar medicines are approved to be medically interchangeable with their reference product, under the supervision of a clinical decision-maker, so that individual patient factors can be duly taken into account (Position Paper). The NOR-SWITCH study is the largest such study to date and its results reinforce the available positive clinical evidence gathered with the use of biosimilar medicines in the last decade in Europe.
While there is a large number of ongoing physician-led switching and observational studies involving biologic medicines (originator and biosimilar), it is essential to highlight the uniqueness of the Norwegian framework in which this study was performed: the NOR-SWITCH study forms an integral part of a wider policy framework from the Norwegian government which involved all concerned stakeholders, including patients’ representatives, in the introduction of biosimilar medicines in clinical practice.
Adrian van den Hoven, Medicines for Europe Director General commented: “This study is part of the growing body of real world evidence available on EU approved biosimilar medicines which provide alternative treatment options for both physicians and patients in 5 key therapeutic areas. It reinforces the Biosimilar Medicines Group efforts to ensure acceptance of biosimilar medicines through education and real world evidence gathering”.
What is a medical or physician-led switch?
A switch is a decision by a physician to exchange one medicine for another medicine with the same therapeutic intent. There are several scenarios however, which all involve a clinical decision maker:
A physician-led switch can be between versions of the same active substances (i.e. originator and biosimilar, biosimilar and biosimilar) but also between medicines in the same therapeutic class (e.g. anti-TNFs). The administered medicine is to be recorded in the patient file and the patients should always be involved in decisions regarding their treatment and informed about the medicine they are prescribed or given. This systematic approach strengthens also traceability in case of any adverse drug reaction (ADRs).