Choreographing US & European Biosimilar Dances: New Developments on Patenting, Similarity & InterchangeabilityCopenhagen Biotech & Pharma Forum (CBPF) Photo: www.biopeople.dk

When?:  June 1st 2017 from 10.00 – 13.00. Where?: Faculty of Law, Meeting box (the “floating” meeting room), 2nd floor, room 7A-2-04, Njalsgade 76, DK-2300 Copenhagen S

Registration: Please register here before May 31th at 2 pm (limited space available)

Organizer: Timo Minssen (Timo.Minssen@jur.ku.dk), Centre for Information & Innovation Law (CIIR), Copenhagen Biotech & Pharma Forum (CBPF)

Biosimilars are biologic medicines that are similar to currently available biologic therapies known as originators. These complex large molecule drugs are considered as the next wave in medicine, promising new treatments to help more patients with serious and complex diseases. Now that patents covering some of these medicines have expired or are approaching expiry, regulators across the world have created new incentives for biologic drug development and new procedures to allow for similar versions — biosimilars — of originator biologics to enter the marketWhile regulatory pathways for the market approval of these drugs have been available in both Europe and in the US for a couple of years, the nature of biosimilars creates many regulatory and definitional challenges and complexities. Moreover, there are an increasing number of new biologics and biosimilar applications on the horizon that give rise to additional questions.Many of the unsolved issues are comparable in Europe and the US, but they will often need to be addressed within different legal settings. The US Supreme Court, for example, will soon decide on crucial questions concerning the so-called biosimilar "patent dance", and whether biosimilar companies have to notify reference product sponsors of the impending marketing of a new product. It can can be assumed that the forthcoming decision will have broad ramifications for all subsequent biosimilars approved by the US Food and Drug Administration (FDA).At this seminar, European and US scientific and legal experts will discuss the implications of these developments both from a regulatory and intellectual property law perspective.

Programme and presentations

10:00- 10:15 Biosimilars, Bio-betters & Bio-worse: What’s the fuss all about and why should we care? Timo Minssen, Professor of Biotechnology Law, Centre for Information and Innovation Law, Faculty of Law University of Copenhagen

This introductory talk provides a brief overview for non-expert participants on the basic features of biologics and biosimilars and explains why these need to be distinguished from traditional small-molecule drugs. This will also include a basic summary of the most relevant legal frameworks and regulatory pathways that apply to biosimilars and an account of why innovators, policy makers, patients and other stakeholders should pay close attention to the recent developments in this increasingly important area of law and technology.

 10:15- 10:45 EU guidelines on Biosimilars: views of a pharmaceutical scientist Marco van de Weert, Associate Professor at the Dept. of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen

In 2001 the European Commission surprised the pharmaceutical industry by allowing a legal pathway for approval of “similar biological medicinal products”, analogous to the much older concept of generics for low molecular weight drugs. It took until 2006 before the first such biosimilar product, Omnitrope, was granted market approval. As of the end of 2016, 22 biosimilars have been approved in the EU, with a further 16 under consideration.In this presentation, I will discuss some of the practical challenges in establishing “similarity” and the uncertainties and opportunities for all affected stakeholders (biosimilar manufacturer, innovator company, regulatory agency, prescribers, and end-users). Focus will be on the pharmaceutical aspects of similarity, highlighting the as yet poorly understood relationship between the often-observed development of an immune response to biological medicinal products, and the quality aspects of the drug product itself.

10:45- 11:00  What’s going on in US Biosimilars Litigation? Srikumaran Melethil, Ph.D., J.D., Registered Patent Attorney, Prof. Emeritus, Schools of Pharmacy and Medicine, Univ. of Missouri-KC, Kansas City, MO

This talk will address litigation issues that have risen in the United States from the provisions of the Biologics Price Competition and Innovation Act (BPCIA) of 2010, which provide a regulatory and legal scheme to market generic biologicals (“biosimilars”). Interpretations of the sections of the statute dealing with the resolution of potential patent disputes between the innovator and the competing generic company, and marketing notification by the competitor company to the innovator (collectively referred to as the “Patent Dance”), have been the major issues in the early phase of biosimilar litigation in the United States. These issues await resolution by the country’s Supreme Court. Issues surrounding the statutory definitions of biosimilarity and interchangeability can be expected to be an area of future litigation; the FDA just (January 2017) issued guidelines for the determination of interchangeability.

11:30- 12:00 Questions and panel debate with Marco van de Weert, Srikumaran “Sri” Melethil & Timo Minssen

12:00- 12:30 Snacks and mingle

About our speakers:

Marco van de Weert:

Marco van de Weert is an Associate Professor at the Dept. of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen where he works at the Protein formulation and Biophysics group, Section for Biologics. He is a (co-)author of 77 peer-reviewed publications and 10 book chapters, as well as Editor of 2 books.Marco holds a MSc in chemistry and a PhD in Pharmaceutical Sciences, both from Utrecht University, The Netherlands. In 2001 he moved to Copenhagen as a postdoc, and in 2006 he took up his present position.His main research revolves around protein pharmaceuticals, with two focus areas: 1) the effect of the surroundings on protein physical stability, and 2) development of novel analytical methods to study protein structure and stability.Both areas are of great importance to the development of safe and efficacious protein pharmaceuticals, including biosimilars. Hence is current research interest includes understanding the challenges and opportunities of biosimilars, in particular related to the nonclinical quality aspects.

Srikumaran “Sri” Melethil:

 Srikumaran “Sri” Melethil, Ph.D., J.D., is both a pharmaceutical scientist and a registered patent attorney. He is admitted to practice in the State of Missouri, before the United States Courts for the Western District of Missouri and before the United States Patent and Trademark Office. Dr. Melethil’s legal practice focuses on patent prosecution and infringement analysis in the area of pharmaceutical sciences.Dr. Melethil has served or serves as a consultant to the pharmaceutical industry, academia, and federal agencies (FDA, National Institute of Environmental Health Sciences, and National Institute of Drug Abuse), and as an expert witness in drug toxicity and blood alcohol cases. He is Professor Emeritus, University of Missouri-Kansas City, Schools of Pharmacy and Medicine. His scientific expertise covers the areas of pharmacokinetics, drug delivery, clinical pharmacology and drug analysis; he has published extensively in these areas. In the legal arena, he has published on the regulation of dietary supplements, World Anti-Doping Agency inclusion criteria for prohibited substances, and drug patent litigation arising under the Hatch-Waxman Act. He has also offered short courses in drug and patent law to life scientists. He is a Fellow of the American Association of Pharmaceutical Scientists, the premier association of his peers, and the American College of Clinical Pharmacology. He serves on the Editorial Board of Clinical Research and Regulatory Affairs, and Advisory Committee of Update, published by the Food and Drug Law Institute.Dr. Melethil received his B. Pharmacy (First Class, First Rank, Gold Medalist), and M. Pharmacy (Manufacturing Pharmacy, First Class) from Andhra University, Waltair, India; his Ph.D. degree in pharmaceutical sciences from the Department of Pharmaceutics (now Pharmaceutical Sciences), State University of New York at Buffalo in New York; and his Juris Doctor degree from the University of Missouri-Kansas City School of Law.

Timo Minssen:

Timo Minssen is Professor of Biotechnology Law at the University of Copenhagen’s Center for Information & Innovation Law (CIIR). His research focuses in particular on Biomedical Innovation Law and he has pub-lished extensively in this area. Heading CIIR’s Biotech & Pharma Research Group, he leads 4 major inter-disciplinary research projects concerning biobanks, synthetic biology, systems biology, precision medicine, and large research infrastructures. He is also scientific advisory board member of the Copenhagen Centre for Regulatory Sciences (CORS) and steering committee member of the Danish Association for the Pro-tection of Industrial Property. Professor Minssen holds a German law degree, as well as biotech & IP -related LL.M and LL.D. degrees from Lund & Uppsala University (Sweden). He has been a Visiting Re-search Fellow at the Universities of Cambridge & Oxford (UK), Harvard Law School, the Chicago-Kent College of Law (US), as well as at the Max Planck Institute for Innovation & Competition (Germany). Moreover, he was trained in the German Court system and at the European Patent Office.