Day 1 :
- Keynote Session
Session Introduction
Laszlo Endrenyi
University of Toronto, Canada
Title: Interchangeability of Biological Drug Products
Time : 09:45-10:30
Biography:
Laszlo Endrenyi is Professor Emeritus of pharmacology and biostatistics in the University of Toronto. He has served the university in various positions including on its Governing Council and as Associate Dean of Graduate Studies. He sat on the Board of Directors of the American Statistical Association and the Canadian Society for Pharmaceutical Scientists; he was a president of the latter and received its Lifetime Achievement Award. Externally, he has served on grant review committees and editorial boards of research journals. He has received several recognitions, including an honorary doctorate from the Semmelweis University of Medicine. He is a Fellow of the Canadian Society for Pharmaceutical Sciences and of the American Association of Pharmaceutical Scientists. Dr. Endrenyi published a book on Kinetic Data Analysis and over 180 research papers. He has advised and widely consulted with industry and regulatory agencies.
Abstract:
Conditions for the interchangeability of biological and small-molecule drug products are very different. Small-molecule drugs are well defined and can be exactly reproduced. If their products, brand-name and generic, are declared to be bioequivalent then they are (most frequently but not always) therapeutically equivalent and can be substituted and interchanged. In contrast, biological drugs are structurally and functionally complicated, can be only imitated but not identically reproduced, are sensitive to various environmental and manufacturing conditions, are subject to biological and immunological influences. Consequently, only high similarity but not equivalence can be demonstrated, in various respects, between the marketed and new products. However, even the stated biosimilarity of two products does not enable their interchangeability in terms of switching and alternating. For this, additional conditions must be satisfied. There has been no agreement on these conditions among the various jurisdictions. Legislation in the United States, and also FDA, has set general principles. The European EMA has issued biosimilarity guidelines for several drug products. The latter permit in some cases possible interchangeability even though the issue is under the judgment of the member states. It is desirable to develop a general, scientific basis for the evaluation of interchangeability of biological drug products. Suitable study designs are considered, an approach for the assessment of switching and alternating across multiple domains is presented, and a possible criterion for the interchangeability of biological products is described.
Candida Fratazzi
BBCR Consulting, USA
Title: Evaluating Immunogenicity in Biosimilars
Time : 10:30-11:15
Biography:
Candida Fratazzi devised the concept of SCIO, cost-effective trial design, and streamlining solutions. She has been involved in the development of several bosimilars. As President of BBCR, she acts as a consultant to biotech, pharmaceutical, medical device companies, and investors. She is a renowned Immunologist and has over 15 years of experience in Orphan Drug development. She is the recipient of 2013, 2014 and 2015 Best Pharmaceutical Consultant award, Cambridge Award and ranked among the top 2014 top ranked US Executives. She helps international companies to enter the US and EU markets. She has been trained at the Johns Hopkins University, Harvard University and at Imperial College in London, UK.
Abstract:
Adoption of biosimilars is increasingly attractive to payers around the globe due to the mounting financial pressure from high expenditures on medical treatments. Clinical evaluation of comparative immunogenicity constitutes an important component of the regulatory review for biosimilar candidates. The anti-drug antibody formations are interpreted, during the review process, in relation to pharmacokinetics, pharmacodynamics, efficacy, and safety parameters. Evaluation of the immunogenicity associated with the biosimilar includes its negative impact on clinical relevant outcomes compared with the innovator product. Unwanted immunogenicity may lead to clinical consequences such as reduced or loss of efficacy, altered pharmacokinetics (PK), general immune and hypersensitivity reactions, and neutralisation of the natural counterpart (e.g. the physiological hormone). Relevant areas of discussion are: testing strategies for immunogenicity assessment; and scientific progress on the product-related factors that may contribute to the development of immunogenicity, in particular that are related to protein aggregation and post-translational modifications. For chronic administration products, immunogenicity monitoring is required for a 12-month period of continuous treatment. Furthermore, the anti-drug antibody titers (i.e., erythropoietin, growth hormone, follitropin-alfa) interpretation is influenced by product quality differences and supported by a single-dose comparative pharmacokinetic study in healthy volunteers. The acceptance margins of detected ADA incidence for the biosimilar candidate versus the innovator product have not yet been defined by EU regulators. Indeed, until now, there is no standard bioanalytical assay sensitivity adopted nor any generalization has been made on the negative influence of clinical evidence on ADA incidence. In conclusion, immunogenicity and ADA evaluation are both complex processes that start during pre-clinical comparability and continue throughout pre approval and post-approval monitoring.
Pawan Saharan
Biomix, USA
Title: Paradime shift in discovery & secretion of biosimilars via path breaking innovation
Time : 11:35-12:20
Biography:
Pawan Saharan has MS in Life Sciences (JNU); PhD in medicine (WVU) & Post Doc. (Stanford University). He has several International Publications/Presentations including in Top Scientific Journal Nature from the age of 21. He was nominated for several Global Awards including by New Drug Discovery Programme of Department of Science & Technology (GoI) funded US$ 3 million grant and the best US Scientist Award at age 22 years by AAAS, Washington DC. He has been CSO & CEO for large MNC & founder of Biomix Network Inc. USA & India.
Abstract:
Pawan Saharan invented Radha108 Nano Peptides extracted from Bovine colostrum that naturally produces biosimilar like Cytokines (Interleukin & Interferon) by secretion from Cytotoxic T- cells of the innate immune system, which was increased by 5 times by of Radha 108 Nano Peptides that get absorbed in the blood through buccal mucosa & crosses the Blood Brain Barrier. Radha 108 act on pituitary gland that in turn promotes differentiation of B cells, maturation of macrophages and monocytes & stimulates production of cytokines IL-1 to IL-11, TNF-α, INF–γ & maturation of immature thymocytes into either helper or suppressor T cells that helps building body's immune system strongly to fight any infection and immune disorders like Asthma, Allergy, URTI, Carcinomas and Type 2 diabetes saving hundreds of Billions of $ that are spent in treating such ailments with little or no efficacy. Radha 108 Nano Peptides SEQ ID 1-8 extracted from Bovine Colostrum (with the Granted US Patent No. 9,249,188 & 8,518,454 B2) consists of ELVPGVPRGTQL (DNA- binding Protein Inhibitor ID -3), VAIIQHMIKKLR (Epstein – Barr virus induced gene-2), LPQEVLNENLLRF (Alpha S1- Casein), RLNARMAELR ( S-adenosylm ethionine synthetase isoform type -1), SSLQVLNMSHN( Toll- like receptor -4), EYQELMNVK (Keratin type II cytoskeletal 59kDa component IV), VDTLNDEINFLR (Keratin type II cytoskeletal 7), DGIVNENLAER ( Ribonucleoside – diphosphate reductase small chain). Thus Radha 108 Nanopeptides stimulates the secretion of biosimilar (wide range of Cytokines like Interleukins, Interferon etc) that are very effective in treating all viral & immune disorders like HIV, Swine flu, Allergy, Asthma, Arthritis, Diarrhea, Fever, Fatigue-Malaise, Anemia, Endometriosis, cold & Flu by playing a Crucial role
Kamali Chance
Quintiles, Inc, USA
Title: FDA/EMA Current thinking on totality of evidence for biosimilar approvals
Time : 12:20-13:05
Biography:
Dr. Kamali Chance is a Vice President and Head, Global Biosimilars Regulatory Strategy, Biosimilars Center of Excellence. She has over 25 years of work experience in the healthcare industry, including the last 17 years in regulatory affairs/regulatory strategy. Dr. Chance has extensive experience working with the FDA and EMA. She advises pharmaceutical and biotechnology companies in the development of region specific and/or global regulatory strategy for the development of biosimilar products. Dr. Chance has authored/co-authored number of articles on the development of biosimilars. She has a PhD in Nutrition/Nutritional Biochemistry, Masters of Public Health and Regulatory Affairs Certification.
Abstract:
The regulatory landscape for the development of biosimilars in the US and EU is dynamic as many of the guidance issued by European Medicines Agency (EMA) have recently undergone revisions and the FDA has issued number of revised guidelines for Quality and Scientific Considerations as well as updated Questions and Answers documents that lend much clarity. FDA has also issued draft guidelines for Nonproprietary Naming of Biological Products as well as Labeling guidelines for biosimilars. This session is designed to provide current status of biosimilar guidelines in the US and EU. The focus will be to identify major updates in order to help sponsors navigate through the complex requirements for the regulatory approval of biosimilars in the US and EU.
Biography:
Vivek Halan has a Postgraduate degree in Biotechnology from Bharathidasan University in Trichy, Tamil Nadu. He was awarded Gold Medal for securing highest aggregates in MSc Biotechnology. He has more than eleven years of research experience in downstream process development of various products in oncology, diabetes, osteoporosis, metabolic disorder, inflammation, rheumatoid arthritis and liver associated diseases. He has worked for various companies such as Magene Life sciences Pvt. Ltd., Avesthagen Ltd., and Syngene International Pvt. Ltd., where he was involved in downstream processing of various biologics, biosimilars, innovators and few other proteins such as Kinases, CD molecules as a target. He has received few R&D Star Awards for his contribution in developing various products during his tenure at Syngene. Moreover, he was also involved in recombinant protein expression in bacterial cells, monoclonal antibodies expression in mammalian cells lines in laboratory scale. He has been involved in technology transfer for various biosimilars and innovator and few molecules are in different stages of clinical trials. Currently, he is heading Downstream Process Development Department at Theramyt Novobiologics Pvt. Ltd.
Abstract:
Biosimilars are increasingly being developed by many companies and used as therapeutics for various diseases worldwide. There is a lot of scope to improve in biosimilar story. Biosimilar products are approved through stringent regulatory pathways in highly regulated markets such as the US, EU, Japan, Canada and Australia following loss of exclusivity of their originator reference product. The development of biosimilar product possesses various challenges such as comparable quality, safety and efficacy to a reference product in addition to other challenges in product development from laboratory to manufacturing scale. Biosimilar from process development, pre-clinical trials and clinical trials up to fill finish meets number of challenges. Quality attributes of monoclonal antibody or bio therapeutic proteins are highly affected by both process and product related impurities. There should be an efficient upstream as well as downstream process to overcome all the bottlenecks and establishing appropriate standards for biosimilarity remains an important area for scientific, legislative and regulatory debate. Cost-effective manufacturing process is a key factor to deliver a biosimilar product into the clinic and the clinical performance of biotherapeutics are highly influenced by manufacturing process. The key factors helps in reducing the cost includes the overall manufacturing process time, high titer producing cells, less number of purification steps, higher recovery and yield of clinically active product. Manufacturing process should be consistent & highly robust. The process includes modern QC & QA procedures, in-process control & process validation. Most importantly, manufacturing process should meet the same standard of originator products and the originator product should be extensively studied during the biosimilar product development. Single use technology applications should be evaluated thoroughly before initiating the uses in a manufacturing facility. The manufacturing processes should be clearly defined, controlled and validated to ensure compliance, clear records and any deviations found that should be investigated and well documented. Manufacturer comprehensively designs the production process taking all relevant guidelines into account.
- Track 2: Emerging Biosimilar in Therapeutics
Track 8: Clinical Studies on Biosimilars
Session Introduction
Sarah Cooper
National Health Service (NHS), UK
Title: Supporting biosimilar clinical trials in the UK
Time : 14:10-14:40
Biography:
Sarah Cooper is a Clinical Nutritionist by background having completed a PhD in Clinical Nutrition at the University of Sheffield, UK. She has over 12 years’ experience of delivering clinical research in a variety of settings. She joined the NIHR CRN in 2010 initially as a Operations Manager for the Specialties and is currently a Business Development Manager (Commercial)
Abstract:
The National Health Service (NHS) is a single healthcare system providing care to over 60 million people from cradle to grave, free at the point of access. The NIHR Clinical Research Network (CRN) is the research delivery arm of the NHS. It provide the world-class infrastructure that allows high-quality clinical research to take place in the NHS. The CRN turns the pledges in the government’s Strategy for UK Life Sciences into reality, by creating a better environment for conducting large scale commercial contract clinical research, so that life sciences companies can allocate clinical studies to the UK with confidence. We help researchers to set up clinical studies quickly and effectively; support the life-sciences industry to deliver their research programmes; provide health professionals with research training; and work with patients to ensure their needs are at the very centre of all research activity. We provide free support to help the life-sciences industry deliver high quality research in the NHS. Our Study Support Service provides access to dedicated research staff and support to assist with commercial contract study delivery across all therapeutic areas throughout the whole of England. It offers a flexible package of tools and services that can be shaped to meet the needs of individual companies. We work with companies to support the lifecycle of the study- from finding the right sites to deliver biosimilar clinical trials, through to support in getting the study set up within the NHS, right until end of recruitment.
Triona Bolger
Navigant Consulting, Inc., USA
Title: The emergence of orphan biosimilars
Time : 14:40-15:10
Biography:
Tríona holds a Ph.D from Kings College London and is a Senior Consultant in the Life Science Practice at Navigant Consulting with a strong interest in commercial strategy for both speciality and big pharma. She has over 4 years experience in life sciences, healthcare and consulting working in projects including stakeholder/payer mapping in an emerging market, market opportunity assessments, commercial opportunity assessment, pricing and product assessments, new product planning, market forecasting, commercial evaluation and brand planning. Tríona previously worked with Alcimed, a boutique consulting firm specialising in innovative sectors: life sciences (food, biotech, health), energy, aerospace, ICT, chemicals, aerospace & defense. Additionally, Tríona worked as a recruitment consultant with SRI Consulting, a specialist recruitment firm serving the Life Science, Consumer, Not for Profit, Climate Change and Academic sectors. Tríona holds a Ph.D in Craniofacial Developmental Biology from Kings College London and a B.A.Sc in Biochemistry from Trinity College Dublin.
Abstract:
There are $33 billion worth of annual revenue for orphan biologics that have expired or are expiring in the next 10 years, yet no biosimilars for these products have surfaced or are in late stage developement. With more clearly defined regulatory pathways for biosimilar approval recently, we address many critical questions facing originators and biosimilar makers: • Will patient identification and clinical trial recruitment pose an insurmountable hurdle for orphan biosimilars? • Will regulators entertain relaxing evidence requirements to enable biosimilar development? • Are physician and patient services a highly proprietary and costly barrier to biosimilars? • Are, or will there be, particular incentives for reimbursement of orphan biosimilars? • Is there a market size threshold for biosimilars to achieve positive commercial returns? To seek answers, we must appreciate the perspectives of four key stakeholders – regulators, payers, physicians and patients. Navigant’s financial modeling shows that orphan biologics with more than $250 million revenue will likely attract biosimilars from a profitability perspective. We are at the precipice of a new biosimilar era. Regulatory pathways have been paved; complex mAbs biosimilars like Remsima have been approved; a wave of patent expiries are sweeping across the product landscape; the first batch of biosimilars are establishing safety and credibility, providing comforting experience to physicians and patients. Investments made by major biologics companies and up starts alike will unmistakably accelerate and intensify the growth of biosimilar markets. In this context, while orphan disease presents a unique set of unknowns to biosimilar players such as the availability of clinical study subjects, KOL loyalty and payer activism, the law of pharmaceuticals will prevail in the end. Pricing strategy and payer effectiveness will be the most critical consideration in its commercial success, while a less strenuous clinical development program will make the path to market that much more favorable.
- Track 4: Regulatory Approach for Biosimilars
Session Introduction
Lueder Behrens
Boehmert&Boehmert, Germany
Title: The importance of IP protection and SPCs for biologics and biosimilar products
Time : 15:15-15:45
Biography:
Lueder Behrens studied biology at the University Bremen (Germany) and University of Glasgow (UK). For his diploma in virology and his PhD in field of immunology, he worked at Max-Planck-Institute for Biochemistry/Neurobiology in Martinsried/Munich. Subsequently, he was postdoctoral researcher in the field of neurovirology at the Institut Pasteur in Paris (F). In 2001, he started his training and legal studies to become a patent attorney. Since 2005 he is fully qualified patent attorney and later became a European patent attorney. He joined the renowned IP law firm Boehmert&Boehmert in 2015 and works in the offices in Berlin and Munich.
Abstract:
Research and Development nessecitates important financial investments, in particular in the pharmaceutical field, where clinicial studies costs easily hundreds of millions of Euros. Patents are important business tool to maintain exclusivity for the products provided in R&D and secure rights on the results of the underlying work. Pharmaceutical product development from lead compounds to the authorized drug easily takes more than 10 years. It is important to maintain product exclusivity in order to guarantee a satisfying return on investment. Biological products are used at increasing frequency in the pharmaceutical field, e.g. as therapeutics in the treatment of cancer and inflammatory diseases, as hormones, vaccines, etc. These products may also be subject to patent protection. It is of utmost importance for pharmaceutical companies to maintain exclusivity for a maximum period as the development and clinical testing up to market entry may be even longer than for small molecule drugs. Supplementary Protection Certificates (SPCs) provide legal means to extend protection for market authorized drugs. Recent decisions of the highest European Courts may provide guidance on the extent of protection conferred by such SPCs in the biopharmaceutical field. These decisions could provide guidance on how to protect biologicals and may influence the market entry of biosimilar products.
Paul A Calvo
Sterne, Kessler, Goldstein & Fox, USA
Title: An update on the legal landscape for biosimilars in the USA
Time : 16:15-16:45
Biography:
Paul Calvo is a Director at Sterne, Kessler, Goldstein & Fox P.L.L.C. in Washington, DC, where he spearheads the firm’s biosimilars practice. He is experienced in advising biopharmaceutical companies ranging in size from startups to industry-leading multinationals on complex legal issues related to the protection and enforcement of their intellectual property. He practices primarily in the fields of immunology and biotherapeutics, with a particular focus on therapeutic antibodies.
Abstract:
The past year has seen a great deal of activity related to the legal challenges for biosimilars in the United States. The legal landscape for biosimilars and the BPCIA is becoming clearer as decisions such as Amgen v. Sandoz are being handed down by the courts and an increasing number of biosimilar applications are being accepted by FDA. Legal challenges are also occurring at the US Patent and Trademark Office as biosimilar applicants attempt to obtain patent certainty in advance of submission of the biosimilar application to FDA. This presentation will outline the current status of the legal activity surrounding biosimilars in the US.
Christoph Volpers
Michalski Hüttermann & Partner, Germany
Title: Intellectual Property Issues in Global Biosimilar Programs
Time : 16:45-17:15
Biography:
Christoph Volpers earned a PhD in Molecular Biology from the University of Mainz, Germany, and an MBA from Bradford University, UK, both with Distinction. Chris has almost fifteen years of experience in Intellectual Property and Licensing. Before he joined the patent law firm Michalski Hüttermann & Partners, Dusseldorf/Munich, as Senior Patent Consultant in early 2015, he was Director IP Biologics of the Teva Pharmaceutical Industries/ratiopharm group for six years with global responsibility for innovative biologics and biosimilar products. He is founder of a biopharmaceutical consultancy firm, author of more than 20 publications and a member of the Licensing Executive Society.
Abstract:
In addition to development, manufacturing and commercial challenges, patent legal issues have a major impact on the success of a global biosimilar program. The multidimensional complexity of the patent landscape relating to a biosimilar candidate is due to the variety of categories of patent rights, encompassing, e.g., compound, process, formulation, indication, dosage and device patents; to the territorial diversity in scope and term of patent protection; to the technical complexity of biopharmaceutical production; and to the rapidly evolving, often controversial case law in this field. All these aspects need to be addressed when it comes to freedom-to-operate analysis and clearance of biosimilar projects, but is also relevant for securing one’s own IP position by filing and prosecuting applications on, e.g., improved process, formulation or device features. The talk will discuss challenges and chances along those lines and will give relevant examples. An update will be provided on some recent developments in patent law which will have an impact on future biologics and biosimilars patent landscapes in major markets, such as the Unitary Patent in Europe and the evolving biosimilars legislation in the US.
Nabeela Rasheed
McAndrews, Held & Malloy, Ltd, USA
Title: Dosing, Double Patenting and the US Biosimilars Landscape
Time : 17:15-17:45
Biography:
Dr. Nabeela Rasheed obtained her PhD at the age of 25 years from University of Liverpool, United Kingdom and after completing two postdoctoral fellowships, she joined a law practice. She has been practicing in the area of Biotechnology patent law for over 20 years. As a licensed US attorney, she counsels in all areas of patent law and has particular experience in working with antibodies and other biologics. She is currently a shareholder at McAndrews, Held & Malloy.
Abstract:
The US Biosimilars landscape is developing in parallel with that of Europe. With the advent of the relatively new Inter Partes Review proceedings at the United States Patent and Trademark Office (USPTO), Biosimilar applicants are provided with a new forum to clear the path for early Biosimilar entry. Currently, the USPTO is reviewing a number of key patents that could impact the early entry of biosimilar versions several blockbuster drugs into the United States market. Key in this review are patents that claim dosing regimens and formulations. How the USPTO and the Courts view such regimens and formulations patents will be crucial in the question of early US Biosimilar entry. In parallel, obviousness-type double patenting, a once arcane judicially-created doctrine has become an extremely prominent defense against various patents in the biologics arena. This session will focus on dosing, formulations, and double patenting and the future of the biosimilar landscape. A comparison of strategies used at the USPTO with those used at the EPO also will be provided.
Duu-Gong Wu
Director of Regulatory Consulting PPD, USA
Title: Regulatory Update and Overview of Specific Scientific Issues for Development and Approval of Biosimilars in US
Biography:
Duu-Gong Wu, Director of Regulatory Consulting at PPD has more than 25 years of combined US FDA and industry experience, working for 14 years at FDA as a reviewer/supervisors and 12 years as a regulatory and CMC technical consultant. He is a well-known expert in regulatory and scientific issues of biosimilar development. Prior to his works as a consultant, he worked at US FDA with the last position as Deputy Division Director of Division of New Drug Chemistry II in CDER Office of New Drug Chemistry, specializing in the review of biological products. In addition to the reviews of a large number of biotech products approved by FDA, He represented CDER as a member of ICH Expert Working Groups for both Q5E (biotech comparability) and Common Technical Document-Quality (CTD-Q) for biotech products from 1998 to 2004. Previously, he also participated in drafting ICH Q6B and Q5C guidance documents for biotechnological drug products. He served as a member of FDA Follow-on Biologic (biosimilar) Working Group, Ad Hoc Reviewer associated with USP Biotechnology Committee and the chairman of FDA CDER Follow-on Growth Hormone and Insulin Working Group responsible for setting the regulatory requirements for the approval of Omnitrope®. Currently, Dr. Wu has been assisting clients in the development of a number of MAb and therapeutic protein biosimilars at various stages with two successful IND submissions to FDA. Dr. Wu completed his Ph.D. degree in Biochemistry and Molecular Biology at University of Maryland School of Medicine and postdoctoral study at Johns Hopkins University School of Medicine, before he joined US FDA.
Abstract:
The passage of 2009 Biologics Price Competition and Innovation Act of 2009 (BPCI Act) in US established a regulatory pathway for the approval and marketing of biosimilars in US. FDA subsequently published a number of general guidance documents between 2012 and 2015 to provide guidelines to the industry on the regulatory process and clarifies the data requirements for the developments and approval of biosimilars. For the final approval of first biosimilar, Filgrastim, FDA also utilized the publication of advisory committee report to lay out the examples of regulatory and data requirements under current biosimilar law. Futhermore, the recent submission of a biosimilar application for Humira® to both EMA and US FDA also represented a milestone with far reaching implications to the field of biosimilar developments in US. Based on Dr. Wu’s unique regulatory experience at FDA and recent interactions with various regularory agencies on the development of several biosimilar Mabs and therapeutical proteins, the presentation will cover the followings: 1) An update on the current regulatory development in the US, 2) Concept of step-wide approaches in demonstratiion of comparability as recommended by FDA. 3) The unique challenges of complex regulatory and scientific issues in US such as User Fees. consultation meetings, reference products, naming, interchangeability of biosimilars. 4) Recommendations to overcome the challenges for the biosimilar product develoment in US.
Peter Bogaert
Peter Bogaert, Covington & Burling LLP, Belgium
Title: Key Regulatory and Legal Developments for Biosimilars in the EU
Biography:
Peter Bogaert is the managing partner of the Brussels office of Covington & Burling LLP where he also heads the life sciences group. He has detailed regulatory expertise under EU and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the European Courts in Luxembourg and in local litigation in Belgium. Mr. Bogaert's practice covers pharmaceuticals, biotechnology, medical devices, special foods and feed, cosmetics and other consumer products and he represents numerous innovative life sciences companies, including start-ups, as well as several industry associations. Mr. Bogaert has been a member of the Brussels bar since 1984 and was called to the English bar in 1995. He holds law degrees from the University of Leuven (magna cum laude, 1982) and Oxford University (first honours, 1984).
Abstract:
The EU operates a well-established biosimilars review process that has more than a decade of experience. Almost all biosimilar applications are reviewed by the EMA, which has issued extensive guidance that covers general principles for review of biosimilars and also addresses specific aspects for various active ingredients. The practices and guidelines are also regularly updated in light of regulatory experience and international developments. Key areas of attention now are: (i) What role should the EMA play with regard to switching and interchangeability? This must be assessed also against the background of the separation of EU and national powers under the EU treaties, which provide, for instance, that the Member States have responsibility for “the organisation and delivery of health services and medical care.” (ii) What role could the EMA play in the context of HTA? Should this focus on relative efficacy or relative effectiveness and would this have an impact on biosimilars? (iii) What role can big data play for biosimilars? The regulatory approval system must also be seen in the broader context, which can have a significant impact on real use of biosimilars. This includes the INN policies of the WHO and the role of public procurement and its practical implications for switching. The talk will focus on these elements and also provide a general update on the regulatory situation in the EU. Recently, for instance, some applications for non-biotech biosimilars were made at the national level and add a new dimension to the picture.