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Scientific Considerations for Complex Drugs in Light of Established Regulatory Guidance

Scientific Considerations for Complex Drugs in Light of Established Regulatory Guidance

Friday, March 9, 2012

The New York Academy of Sciences

Presented By

Presented by the New York Academy of Sciences


On February 9, 2012, the U.S. Food and Drug Administration (FDA) released their much-anticipated draft guidelines for implementing the Biologics Price Competition and Innovation Act (BPCI) of 2009, which called for an abbreviated approval pathway for biological products that are demonstrated to be "highly similar" to or "interchangeable" with a drug regulated under the Public Health Service Act. The details of this pathway discuss issues that are far more complicated than those posed by traditional, small molecule generics, including what type of pre-clinical/clinical data, safety, purity, immunogenicity and potency testing will be required by the FDA in the marketing application. Additionally, while current regulations do not make scientific distinctions between small-molecule drugs and non-biological complex drugs (NBCDs), NBCDs present many of the same scientific challenges to reproduce as biologics, and future regulations will likely be guided by lessons learned from the development of policy for biosimilars in the U.S. and abroad.

This international, scientific conference will focus on considerations for the NBCD regulatory approval pathway given the emerging guidelines for biosimilars. Representation from the FDA will provide an overview of the demonstration of therapeutic equivalence of complex drug products, which shall inform the day’s broader discussions. Plenary sessions will address the most recent regulatory developments, experimental design, interchangeability and immunogenicity issues for follow-on versions of complex drugs from the perspective of key audiences, including industry, regulatory agencies, physicians, and consumers.

Registration Pricing

Student / Postdoc / Fellow Member$50
Nonmember Academia$150
Nonmember Corporate$250
Nonmember Not for Profit$150
Student / Postdoc / Fellow Nonmember$50


Presented by

  • The New York Academy of Sciences

Platinum Sponsor

  • Teva Pharmaceuticals


* Presentation times are subject to change.

Friday, March 9, 2012

8:00 AM

Breakfast and Registration

9:00 AM

Opening Remarks
Brooke Grindlinger, PhD, The New York Academy of Sciences

9:15 AM

Keynote Address
Small Molecules, Biologics and Non-biological Complex Drugs: An Overview of their Scientific and Regulatory Differences
Chris Holloway, BSc, PhD, ERA Consulting Group

10:00 AM

Biosimilar Monoclonal Antibodies: Current European Developments
Jan Mueller-Berghaus, MD, Paul-Ehrlich-Institut — Federal Institute for Vaccines and Biomedicines, Germany


10:30 AM

Networking Coffee Break

11:00 AM

Insights into the Process of Establishing Regulations for NBCDs
Beatriz Silva Lima, PhD, iMED.UL, University of Lisbon

11:30 AM

Experimental and Clinical Trial Evidence Needed for Follow-on Versions of Complex Drugs
Huub Schellekens, MD, PhD, Utrecht University

12:00 PM

Therapeutic Equivalence of Complex Drug Products: Case Study of Generic Calcitonin Nasal Spray Products
Sau (Larry) Lee, PhD, U.S. Food and Drug Administration

12:30 PM

Scientific Challenges in Regulating Complex Biological Products in Emerging Markets
Ivana Knezevic, MD, MSc, PhD, The World Health Organization

1:00 PM

Networking Lunch
Speaker-guided Discussion Groups
Topic: Defining Complex Drugs

2:30 PM

Panel Discussion: Defining Complex Drugs

3:15 PM

Clinical Barriers to the Adoption of Biosimilars: A Lesson for Complex Drugs
Andrew D. Zelenetz, MD, PhD, Memorial Sloan-Kettering Cancer Center

3:45 PM

Follow-on Biologics: A Patient's Perspective
Janet S. Wyatt, PhD, RN, FAANP, Institute of Pediatric Nursing and Arthritis Foundation

4:15 PM

Networking Coffee Break

4:45 PM

Panel Discussion: Complex Drugs, Physician and Patient Opinion

5:15 PM

Closing Remarks
J. Michael Nicholas, PhD, Teva Pharmaceuticals

5:30 PM




Daan J. A. Crommelin, PhD

Utrecht University

Prof. Daan Crommelin is professor at the Department of Pharmaceutics at Utrecht University. Until December 211 he was scientific director of the Dutch Top Institute Pharma in Leiden. He is adjunct professor at the Department of Pharmaceutics and Pharmaceutical Chemistry at the University of Utah. Crommelin is co-founder of OctoPlus, a Leiden based company specialized in the development of pharmaceutical product formulations and advanced drug delivery systems. He published extensively and is on the editorial board of 10 peer reviewed journals in the pharmaceutical sciences. He also advises venture capital groups. He chaired the Board of Pharmaceutical Sciences of the International Pharmaceutical Federation (F.I.P.), was chair of the organizing committee of the Pharmaceutical Sciences World Conference 2007 in Amsterdam. He is past president of the European Federation of Pharmaceutical Sciences (EUFEPS) and vice-chair of the scientific advisory board of the European Innovative Medicines Initiative (IMI).

Chris Holloway, BSc, PhD

ERA Consulting Group

J. Michael Nicholas, PhD

Teva Pharmaceuticals

J. Michael Nicholas, PhD, received his PhD in pharmacology from the University of Tennessee Center for Health Sciences. After postdoctoral work at the University of Mississippi in Jackson he joined Mylan Pharmaceuticals in Morgantown, WV as Director of Scientific Affairs. While at Mylan he later served as Director of Scientific and Regulatory Affairs and was involved with the development and approval of both generic and branded products. Following Mylan, he accepted a position with Marion Laboratories in Kansas City in the Regulatory Affairs department. Over the years Dr. Nicholas has been involved with all aspects of regulatory matters including product development and approval. While at Marion Laboratories, Marion Merrell Dow and Hoechst Marion Roussel, Dr. Nicholas served as the Director of Product Approval within the Regulatory Affairs Department and directed the submission of INDs, NDAs, and their subsequent approval. Prior to his current position, he was Vice President, US Regulatory Affairs and Compliance, Marketed Products for Aventis Pharmaceuticals and was responsible for regulatory matters for approved products. Currently, Dr. Nicholas is Head of Life Cycle Initiatives for Teva Pharmaceuticals and is responsible for product life cycle planning.

Andrew D. Zelenetz, MD, PhD

Memorial Sloan-Kettering Cancer Center

Keynote Speaker

Chris Holloway, BSc, PhD

ERA Consulting Group

For the past 25 years, Chris has held the position of Group Director of Regulatory Affairs and Chief Scientific Officer of the ERA Consulting Group, during which time he has been involved in projects on the development of more than 450 biological and other complex medicinal products, ranging from natural products to advanced therapy medicinal products (gene, cell and tissue engineered products). Previously, he was Professor of Clinical Biochemistry and Physiological Chemistry at Hannover Medical School in Germany, where, in the early 1980s, he became involved in the evolving evaluation process for products of recombinant DNA products, which at that time were in their infancy. He remains a member of the teaching faculty of Hannover Medical School. Apart from his expertise in regulatory strategies for novel biopharmaceutical products in Europe and the US, and work on issues relating to comparability of biologicals, Chris has a particular interest in the challenge and needs of evaluating complex medicines in emerging countries and the developing world, to which end he has provided training sessions for regulators of those jurisdictions. Furthermore, Chris has considerable expertise and experience in the field of follow-on products, especially with regard to biosimilars and complex non-biological drugs.


Ivana Knezevic, MD, MSc, PhD

The World Health Organization

Dr Knezevic has eighteen years of professional experience in standardization and regulation of biologicals. During the first seven years, the expertise in the production, quality control and overall evaluation of vaccines and biological therapeutics was developed at the national level. In 2000, Dr Knezevic joined WHO Biological Standardization Programme and since then her activities have been devoted to the standardization and evaluation of biologicals at the global level. This includes development and establishment of WHO International Standards as well as the assistance to the regulators, manufacturers and other users of these standards. Since 2006, she has been leading standardization of vaccines and some biological therapeutics. Dr Knezevic led development of WHO regulatory guidelines on various aspects of vaccine evaluation (ie, stability, non-clinical and clinical) as well as the recommendations for production, control and evaluation of selected vaccines, published in WHO Technical Report Series. In the area of biotherapeutics, she coordinated development of the WHO Guidelines on evaluation of similar biotherapeutic products (SBPs) and has initiated a series of workshops to facilitate implementation of guiding principles into regulatory and manufacturers' practice. Dr Knezevic is also the author of several publications that made broad audience aware of WHO initiative in the development, establishment and implementation of standards for vaccines and some other biological products.
Dr. Knezevic is Specialist in Medical Microbiology and Parasitology. She received her MD from the University of Novi Sad, her MSc in Medicine (Microbiology) and PhD in Medicine (Virology) from the University of Belgrade, Republic of Serbia.

Sau (Larry) Lee, PhD

U.S. Food and Drug Administration

Dr. Sau (Larry) Lee received his Ph.D. degree in Chemical Engineering from Princeton University. His background encompasses a wide spectrum of topics in biotechnology, including protein formulation and characterization, and mathematical modeling of complex biological systems. As a member of the Office of Generic Drugs' Science Staff, he was responsible for developing scientific criteria and standards for review and approval of Abbreviated New Drug Applications (ANDAs) for complex drug products, including salmon calcitonin, heparin, enoxaparin, and orally inhaled drug products.

Jan Mueller-Berghaus, MD

Paul-Ehrlich-Institut — Federal Institute for Vaccines and Biomedicines, Germany

Jan Mueller-Berghaus is a certified paediatrician and holds a M.D. He worked as a paediatrician at the paediatric hospital of the University of Cologne, Germany, from 1991 to 1998. Subsequently he gained experience as a researcher and immunologist during a stay in the USA (University of Pittsburgh, Department of Surgery) from 1998 to 2002 and as a clinician/scientist at the German Cancer Research Center (DKFZ, Clinical Cooperation Unit Skin Cancer), Heidelberg from 2002 to 2005.

He joined the Paul-Ehrlich-Institut in 2005 as a clinical assessor and is currently Head of the Monoclonal and Polyclonal Antibodies section. The Paul-Ehrlich-Institut is the German Federal Agency for Sera and Vaccines and is involved in all aspects of German and European marketing authorisation as well as clinical trial authorisation. He is also co-opted member of the Committeee for Medicinal Products for Human Use (CHMP) and a member of the Scientific Advice Working Party (SAWP) at the European Medicines Agency (EMA).

Huub Schellekens, MD, PhD

Utrecht University

Dr. Huub Schellekens is professor of Pharmaceutical Biotechnology at Utrecht University in the Netherlands. He teaches Medical Biotechnology at the Department of Innovation Studies and has a research position at the Faculty of Pharmaceutical Sciences at the same university. He is a member of the Dutch Medicine Evaluation Board and National Expert of the European Medicine Evaluation Agency. He is member of the Board of the European Immunogenicity Platform. He is a medical microbiologist by training and works on the preclinical development of biopharmaceuticals. He published more than 300 papers in peer reviewed international journals concerning many aspects of the development of therapeutic proteins. During the last years his work has included the immunogenicity of protein drugs and the problem of biosimilars.

Prior to joining Utrecht University, he was deputy director of the Dutch Primate Center, director of Medscand Ingeny and medical microbiologist at the Reinier de Graaf Hospital in Delft the Netherlands. In 1992-1997 he coordinated a EU concerted action on the antigenicity of r-DNA derived pharmaceuticals

He studied medicine at Erasmus University in Rotterdam, The Netherlands (1967-1973). There he also did his training in Medical Microbiology (1976-1980) and received his Ph.D. in 1980.

Beatriz Silva-Lima, PhD

iMED.UL, University of Lisbon

Maria Beatriz Silva Lima is PharmD and PhD in Pharmacology and is full professor of Pharmacology and Pharmacotoxicology at the Lisbon, University, Faculty of Pharmacy, and head of the Department of Pharmacological Sciences. She is the Coordinator of the research Group of Pharmacological Sciences of the iMED.UL, where she heads also the research Group in NonClinical safety and Regulatory Science.  Beatriz Silva Lima is expert in nonclinical and regulatory science at Infarmed and EMEA, being member of the Commitee of Human Medicines (CHMP), Commitee of Advanced Therapies (CAT) and Scientific Advice Working Party (SAWP). She is Chair of the Safety Working Party (SWP) and has been involved as Co-Deputy in ICH discussions on ICH M3R2 and S6R1 guidelines on behalf of the European Commission.

Janet S. Wyatt, PhD, RN, FAANP

Institute of Pediatric Nursing and Arthritis Foundation

Jan Wyatt served as the Chief Executive Officer of the Pediatric Nursing Certification Board (PNCB) from 1998 to the March 2011, leading the development of advanced practice pediatric nurse practitioner and general practice pediatric nursing certification programs for more than 35,000 nurses in the US and Canada. In 2009, Dr. Wyatt led the establishment of the new Institute of Pediatric Nursing, a non-profit affiliate of the PNCB and as its current Executive Director works with nursing leadership from children’s hospitals and national nursing organizations to improve education, research and pediatric nursing practice to secure the future health and well-being of children and youth.

Prior to her focus on certification strategy and association management, Dr. Wyatt served more than 20 years as a graduate faculty member in a number nursing programs leading the development of nurse practitioner programs at several universities throughout the US. As a nurse practitioner Dr. Wyatt spent more than 30 years in primary care clinical practice, focusing on health promotion and chronic disease management. Her clinical experiences range from nursing director of the first Geriatric Evaluation and Management Unit at the Veterans Hospital Baltimore, MD to director of Community Health Nursing services for the NATO military family community at SHAPE, Belgium. She also completed 2 years of active service in the US Navy Nurse Corps and more than 15 years in the US Army Nurse Corps Reserves.

Dr. Wyatt was recently appointed to a three term on the National Advisory Council for the Agency for Healthcare Quality and Research (AHRQ) of the Department of Health and Human Services. She also serves as a volunteer member of the Board of Directors of the national Arthritis Foundation and serves as Chair of the Arthritis Foundation’s Public Policy Committee. Other appointments include volunteer service on the Board of Directors of the US Bone and Joint Initiative and the Board of Directors of the Institute for Credentialing Excellence.

Dr. Wyatt received her BSN from Keuka College, her MSN from the University of Alabama–Birmingham School of Nursing and her PhD from the University of Maryland, College Park.

Andrew D. Zelenetz, MD, PhD

Memorial Sloan-Kettering Cancer Center

Andrew D. Zelenetz, MD, PhD is the Vice Chair, Medical Informatics, in the Department of Medicine at Memorial Sloan Kettering Cancer Center (MSKCC) in New York. Prior to that, he had held the position of Chief, Lymphoma Service in the Division of Hematology/Oncology at MSKCC from 1994-2011. He is also Associate Professor of Medicine at Weill Medical College of Cornell University. Dr Zelenetz’s research focuses primarily on improving clinical outcomes in lymphoma and on the molecular mechanisms of non-Hodgkin lymphoma.

Dr. Zelenetz received his BA from Harvard College, his PhD from Harvard University’s Graduate School of Arts and Sciences, Division of Medical Sciences and his MD from Harvard Medical School. Both his internship and residency in medicine were completed at Stanford University Medical Center as well as a clinical fellowship and research fellowship in oncology.

Dr. Zelenetz is a member of the American Society of Hematology, the American Society of Clinical Oncology and the American College of Physicians. He participates in various committees: he is Vice Chairperson of the Cancer and Leukemia Group B Lymphoma Core Committee, Chair of the NCCN Non-Hodgkin’s Lymphoma Panel, Board Member of the Leukemia and Lymphoma Society and member of the Lymphoma Research Foundation Scientific Advisory Board. He has been the recipient of the Memorial Sloan Kettering Fellowship Teaching Excellence Award multiple times

Throughout his career, his research has been published in such journals as BLOOD, the Journal of Clinical Oncology and Clinical Cancer Research.



Small Molecules, Biologics and Non-biological Complex Drugs: An Overview of their Scientific and Regulatory Differences
Chris Holloway, BSc, PhD, ERA Consulting Group, London, United Kingdom

We are concerned here with "follow-on" or "me-too" products, i.e. medicinal products that attempt to mimic as closely as possible the attributes of an already approved and marketed innovative product. Such products are allowed an abridged development program for marketing authorization, after the patent life of the reference product has expired. For drug substances that are small molecules, "essential similarity" can be confirmed with a high degree of certainty, and out of this scientifically valid fact has evolved the regulatory concept of a generic drug, which requires no nonclinical animal testing and only confirmation of bioequivalence without a requirement for clinical trials to prove efficacy and safety. This approach, however, is not appropriate for biologics, as these are complex macromolecules with attributes that may be linked to their specific manufacturing process. For that reason, a different paradigm, that of a "biosimilar" product, has been developed for "follow-on" biologics, with a requirement for some nonclinical studies and clinical confirmation of comparability in terms of efficacy and safety, albeit abridged with respect to requirements for a completely novel biologic. The regulatory situation with regard to non-biological complex drugs (NBCDs) is less well defined, although it is generally recognized that a generic approach is also not appropriate for these products. In many ways, NBCDs represent an even more difficult case than "biosimilars", as there are more constraints on demonstrating structural and functional similarity. Furthermore, classical bioequivalence testing, even if technically possible, has little scientific meaning. For that reason, it is argued from the scientific perspective that regulatory requirements should take such limitations into account. In this overview, the need for a regulatory approach based on a solid scientific rationale will be discussed, and linked to current requirements for small molecular drugs, biologics and NBCDs that are intended as "follow-on" medicinal products.

Biosimilar Monoclonal Antibodies: Current European Developments
Jan Mueller-Berghaus, MD, Paul-Ehrlich-Institut, Langen, Germany

The concept of similar biomedicinal products (biosimilars) has been included in the legal framework for the authorisation of medicinal products in Europe since 2001. This framework of “biosimilar” medicinal products in Europe does not preclude the development of “biosimilar” monoclonal antibodies. Therefore the European regulatory system has recently been encountered and challenged by the first proposals for the development “biosimilar” monoclonal antibodies. The current legislation foresees a stepwise approach, starting at the level of pharmaceutical quality, advancing to non-clinical investigations and commencing with clinical trials. Two workshops at the European Medicines Agency (EMA) brought together the different stakeholders and advanced the understanding of the challenges inherent for this particular class of drugs. Although monoclonal antibodies are large molecules, the known structure-function relationship of these macromolecules may be particularly suited for the biosimilar approach. Specific controversies that will be discussed relate to the use of different expression systems, specific differences in glycosylation, difficulties for preclinical in vitro and in vivo studies and the discussion on the clinical development.

Coauthor: Christian Schneider, MD, Danish Medicines Agency, Copenhagen, Denmark

Insights into the Process of Establishing Regulations for NBCDs
Beatriz Silva Lima, PhD, iMED.UL, Lisbon University, Portugal

Non-Biological Complex Drugs (NBCDs) include medicinal products for which the active substance, like for biologics, consists of different (closely related) structures that can’t be fully quantitated, characterized and described by (physico)-chemical analytical means. Nanoparticle formulations, e.g., liposomes, iron sucrose, block copolimer mycelles, are under this definition. Consequently to the inherent structural variability of the components, adapted strategies to determine comparability of copies vs originator, and possibility and conditions for their interchange are needed. Indeed, in contrast to any generic formulations, the comparable pharmacokinetic profile (bioequivalence) cannot be sufficient to presume equivalent activity, since e.g., tissue and cellular biodistribution may be influenced by multiple structural aspects which may carry different levels of variability. The potential for differences on safety and efficacy need therefore to be carefully evaluated as a support for interchangeability. While the efficacy of putative copies can be studied in clinical trials, several aspects impacting on safety cannot be studied in humans, as is the case for differential tissue, and cellular distribution. Therefore, while for biologics the most relevant information is considered to derive from appropriate quality characterization and comparative human kinetics/efficacy/safety, for NBCDs a set of nonclinical studies in vitro and in vivo may need to be considered and conducted to support their equivalent level of safety and efficacy. An expert group of the European Medicines Agency is addressing the quality, nonclinical and clinical aspects to support equivalence between copies and originator NBCDs.

Experimental and Clinical Trial Evidence Needed for Follow-on Versions of Complex Drugs
Huub Schellekens, MD, PhD, Utrecht University, The Netherlands

The classical generic approach based on showing pharmaceutical equivalence (ie, identical active substances) and bioequivalence (ie, comparable pharmacokinetics) has been the basis of the introduction of many safe and effective alternatives to innovative medicines. However this approach can only be applied to products which can be fully characterized, with a known mode of action and for which serum levels correlates with efficacy. For off-patent versions of biologics the European Union and other regulatory agencies have introduced a new regulatory biosimilar pathway which mandates clinical trials to show therapeutic equivalence. The type of comparative clinical trials, the number of patients to be included and the clinical endpoint are dependent of the type of therapeutic proteins. However for other complex drugs such as the iron-carbohydrate drugs, liposomal drugs, heparins and the glatiramoids regulatory guidance is still mostly lacking. The type of biological and clinical data that would provide an acceptable level of confidence in the efficacy and safety of these products will be discussed.

Therapeutic Equivalence of Complex Drug Products: Case Study of Generic Calcitonin Nasal Spray Products
Sau (Larry) Lee, PhD, U.S. Food and Drug Administration, Rockville, Maryland

The Office of Generic Drugs of the US-FDA has reviewed and approved numerous generic complex drugs products, including synthetic peptide products, heparin and low molecular weight heparin products. In comparison to conventional "small molecule" drugs, review and approval of complex drug products under the Abbreviated New Drug Application (ANDA) regulatory pathway is considerably more challenging, particularly with respect to demonstration of pharmaceutical equivalence. To understand the underlying science used to evaluate these complex products, the standards for review and approval of synthetic generic calcitonin nasal spray products will be discussed. This presentation will focus on two key aspects of pharmaceutical equivalence for the synthetic peptide nasal spray product. The first aspect is drug substance sameness—a proposed generic salmon calcitonin product must be shown to contain the same active ingredient as its brand-name counterpart. The second aspect is comparability of product- and process-related factors that may influence immunogenicity (i.e., peptide-related impurities, aggregates, formulation, and leachates from the container/closure system). Using salmon calcitonin as an example, the importance of knowledge about the reference product and the integrated analytical technologies (i.e., an array of properly designed high-resolution analytical characterization methods, biochemical and/or biological assays) in the evaluation of complex drugs will be illustrated.

Scientific Challenges in Regulating Complex Biological Products in Emerging Markets
Ivana Knezevic, MD, MSc, PhD, World Health Organization, Geneva, Switzerland

Biotechnology derived medicinal products are presently the best characterized biologicals with considerable production and clinical experience. Availability of these products is critical for successful treatment of many life-threatening and chronic diseases. These products are often expensive for the majority of patients who need them most. The expiry of patents and data protection for the first generation of biopharmaceuticals, mainly recombinant DNA derived products, such as interferons, growth hormone and erythropoietin, was recognized as an opportunity for producing copies of these products as affordable medicines with a great potential for increasing access to them. The question that immediately arose was how should such copies of the originator products be licensed, bearing in mind that they are highly complex biological molecules produced by equally complex biological production processes with their inherent problem of biological variability. Copying biologicals is much more complex than copying small molecules and the critical issue was how to handle the licensing of products if relying in part on data from an innovator product. Since 2004 there has been considerable international consultation on how to deal with biosimilars and biological copy products. Much investment in the development of these products is now going on in many countries, including those with emerging economies. Following on the publication of WHO Guidelines on the evaluation of similar biotherapeutic products, a survey in 13 countries was conducted. It is clear that building the expertise and capacity in regulatory agencies as well as in manufacturing sites needs to be done.

Coauthor: Elwyn Griffiths, PhD, Kingston upon Thames, United Kingdom

Clinical Barriers to the Adoption of Biosimilars: A Lesson for Complex Drug
Andrew D. Zelenetz, MD, PhD, Memorial Sloan-Kettering Cancer Center, New York, New York

The Biologics Price Competition and Innovation Act of 2009 (BPCI) is a component of the Patient Protection and Affordable Care Act signed into law on March 23, 2010. BPCI provides a pathway for abbreviated approval of biological products that are demonstrated to be "highly similar" (i.e., biosimilar). A biologic product is considered to be biosimilar to a reference product if analytical studies demonstrated that it is highly similar to the reference product and utilizes the same mechanism or mechanisms of action for the condition or conditions of use prescribed. Biosimilar also need to be compared to the reference product in clinical trials to demonstrate similar efficacy (the trials do not appear to require statistically equivalence). BPCI also allows biosimilar drugs to be deemed interchangeable with the originator product enabling substitution for the reference product by a pharmacist without notification of the prescriber. To date, the FDA has not provided detailed guidance regarding biosimilars in contrast to the EMA which provided guidance and has approved several biosimilars. However, in Europe the health care professional must determine interchangeability. A central question is what data would be persuasive to a clinician to overcome hesitation about biosimilars. Biologic agents are most commonly used in the treatment of cancer and account for a significant proportion of expenditures for cancer drugs. Biosimilars potentially will have a major impact on cancer care. Rituximab is a monoclonal antibody directed against CD20 expressed on human B cells. In 2010, the total expenditure for rituximab in the Untied States was 1.4B dollars. I will use rituximab as a case study examining the potential for a rituximab biosimilar and what hurdles I see for its adoption.

Follow-on Biologics — A Patient's Perspective
Janet S. Wyatt, PhD, RN, FAANP, Institute of Pediatric Nursing and Arthritis Foundation, Round Hill, Virginia

Since the 1990's more than 350 million patients have benefited from biologic treatments. Today there are over 650 new biologic medicines and vaccines being developed to treat over 100 diseases. While cost has often limited access to these miracle medicines in the US, the European Union together with Japan, Australia, Canada and others have pursued the development of bio-similar products, working to balance sound science and patient safety with the goal of delivering lower cost biologic therapies. While billions are at stake and politics and production issues lead the headlines, the needs of patients must be explored and their most pressing questions answered: Will a new biosimilar be the best and safest drug for me? Can I rely on this medicine to provide sustained long-term symptom relief and disease benefit without undue immunogenic side effects and adverse reactions, and... Can I return to my former biologic treatment (and get the same benefit) if this one fails?

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