Day 1 :
Keynote Forum
Marlene Llópiz-Avilés,
Association of Medical Specialists in the Pharmaceutical Industry, Mexico
Keynote: Biosimilars: Latin America´s Coming On Board: Regulatory Approval and Market Access
Time : 09:30-10:30
Biography:
Dr. Llópiz-Avilés is a renowed pharmaceutical medicine specialist with over 25 years of experience in regulatory affairs, pharmacovigilance, medical affairs, clinical research and market access for diverse drugs. She is currently President of the Association of Medical Specialists in the Pharmaceutical Industry. She hold a Bachelor of Arts degree from Austin College, Texas; an MD degree from Universidad Anáhuac, Mexico and an MPH degree from Harvard University.
Abstract:
Biotechnological medicines are medicinal products of biotechnological origin that contain proteins derived from DNA technology. The biotechnologies use living organisms such as plant and animal cells, bacteria, viruses and yeasts for the production of medicines that include such biological factors as cytokines, hormones, clotting factors, monoclonal antibodies, vaccines, etc. Biosimilars are attempted copies of existing biological medicinal products or protein drugs. They are made with a different cell line and a different manufacturing and purification process.Biosimilars come about from the expiry of patent protection for many original medicines. They are considered as possible products at lower costs in comparison to modern therapies for patients and governments and are often more acceptable by patients. Less time and money is spent on clinical research for them to reach the market, as well as less pharmacovigilance. The experience with biosimilars to date is limited and long term safety and efficacy are unavailable. Immunogenicity is often unknown. Because of the above, there is need for appropriate regulations, the clear identification of potential problems and close pharmacovigilance.Latin America has become a new marketplace for the commercialization of biosimilars. However, the lack of regulations, requiring strict clinical trials and close pharmacovigilance has created Latin America an easy target for local and foreign companies to market biosimilars. As in all countries, significant clinical and non-clinical testing should be required for biosimilars to be marketed in Latin America. Substantial NDA-type dossiers should be submitted and post-market safety surveillance must be carried out. For that to occur, substantial manufacturing investments, and sales promotion and marketing are required to be set in place. Latin America can certainly become a safe marketplace for biosimilars only and now that regulatory strategies are set in place, and clinical and non-clinical trials are conducted with detailed pharmacovigilance before and after their marketing.
Keynote Forum
Arthur G Cook,
ZS Associates, USA
Keynote: The Commercial Landscape for Biosimilars: Planning in an Uncertain Environment
Biography:
Art is a Principal with ZS Associates in San Francisco, CA. His experience is in strategic planning, forecasting, market research, pricing, and decision analysis. Art has worked with pharmaceutical companies across 25 countries in North America, Latin America, Asia, Europe, and Australia and has developed forecasts for products in over 150 different therapeutic areas. Art’s experience prior to joining ZS Associates includes positions at two major pharmaceutical companies. He also has been a featured speaker at numerous pharmaceutical and health care industry conferences and is the author of the 2015 second edition book entitled “Forecasting for the Pharmaceutical Industry.” Currently he heads the Biosimilars Center of Excellence at ZS Associates.
Art holds an MBA from the University of California at Berkeley, a PhD in Chemistry from Harvard University, and a BS in Chemistry from Stanford University.
Abstract:
Over the next 10 years $71 billion in worldwide biopharmaceutical revenue may be affected by the launch of biosimilar products. Several biosimilar launchs already have taken place in multiple countries, and observations from uptake in these markets hold insight for strategic planners. In countries such as the US the commercial landscape is complicated by additional uncertainties in regulatory and legal policy. In this talk we will examine the learnings from prior lauches and apply these insights in a decision analysis framework to aid in planning for future biosimilar introductions
Keynote Forum
Kristin A. Connarn,
McDermott Will & Emery, USA
Keynote: Impact of Biosimilars on Patent Portfolio Development and Management
Biography:
Kristin Connarn has completed her BS at Worcester Polytechnic Institute (WPI) and JD from Suffolk University Law School. She is a partner at McDermott Will & Emery. Kristin is known for her work in strategic portfolio development and management, patent prosecution, opinions, licensing, due diligence and related counseling for life science companies. She has a particular focus and expertise in the developing law of biosimilars, and regularly speaks and writes on the topic, as well as counseling biologics innovators on appropriate intellectual property strategies to protect their innovative products. Kristin also serves as the co-chair of the AIPLA biosimilars committee.
Abstract:
Case study on the patent portfolios of the top biologics (in sales) and how they might be impacted by biosimilar strategies. By analyzing the patent portfolios of a representative sample of innovator products, it is possible to see how organizations have approached protecting their top products thus far. Now consider whether those strategies need to be modified to protect the company’s competitve advantage from follow-on biologics. In the case of biosimilars there are a number of steps involved in producing essentially similar, but not identical substances. Protecting the company’s competitive advantage, especially with the use of multiple patent filings, may be essential where the primary biosimilar product or functionality is seemingly unpatentable. A biosimilar may be sufficiently similar to qualify as a biosimilar under the guidelines, but not squarely covered by a patent claim of the innovator product. Innovators should thus aim to draft valid claims that secure broad protection for their biologics. To do so, they should consider seeking protection not only for the biologic itself, but also for the target molecule(s) of the biologic, methods of use and methods of production, if possible. Innovators should also consider how their biologics might be modified and consider obtaining patent protection for those modifications, as well as for any improvements to their biologics.
- Emerging Biosimilars in Therapeutics | Biosimilar Companies and Market Analysis
Session Introduction
Dr. Hossein Pakdaman
Shahid Beheshti University of Medical Sciences, Iran
Title: Biosimilars in treatment of multiple sclerosis in Iran
Biography:
Hossein Pakdaman graduated in Neurology from the Pennsylvania and Henry Ford University (1976). He is Professor of Neurology affiliated to Shahid Beheshti University School of Medicine (since 1990), President of Iranian Neurological Association (since 1991), Director of Iranian Neurological Board Examination (since 1978). Also, he has published more than 40 papers in international journals and is Chairman of Iranian Journal of Neurology (since 1998).
Abstract:
The estimated number of multiple sclerosis patients increased from 2.1 million in 2008 to 2.3 million in 2013. In Iran, the prevalence of multiple sclerosis increased from 45/100,000 in 2011 to 54.5/100,000 in 2013. In capital, multiple sclerosis prevalence had increased from 51.9/100,000 in 2008 to 74.28/100,000 in 2011. In fact, the incidence of multiple sclerosis significantly increased from 3.77 in 2007 to 5.68/100,000 in 2013, annually. Various reports show the significant increased economic burdens multiple sclerosis on patients, on their families, and on government.A biosimilar drug is a biologic medical product which is almost a matched copy of a reference "innovator" product that is synthetized by a different company. Biosimilars are a new class of drugs intended to offer comparable safety and efficacy to the original, off-patent biological.Indeed high expenses of many biological medicines has led to the development of biosimilars in Iran similar to other countries. Development of biosimilars are not feasible because of structural complexity, manufacturing process and the possible risk for immunogenicity. The main limitations with biosimilar are that, the two biosimilar have a different origin, the two biosimilars may have same therapeutic effect, may have different side-effects and hence require thorough testing.There several biosimilars that are prescribed for multiple sclerosis patients in Iran. In 2005, CinnoVexTM as the first biosimilar IFN-beta-1a was produced in Iran and is still available in the market. About 2/3 of patients with multiple sclerosis in Iran are on biosimilars. Of note, the efficacy and safety of such products were assessed and stablished in different experimental and clinical controlled studies.
Balram Pani,
Bhaskaracharya College of Applied Sciences -University of Delhi, India
Title: Systematic Shortlisting of Candidate Molecules and Biosimilar/Biobetter Product Development: An Undergraduate Research Effort
Biography:
Dr. Balram Pani, the Principal of Bhaskaracharya College of Applied Sciences, is also a faculty in the Department of Chemistry, University of Delhi. He obtained his PhD from Jawaharlal Nehru University. Dr. Pani has 20 years of research and teaching experience in the field of chemistry and Environmental Science. He has also authored various books on Environmental Science and Engineering chemistry, which have been adopted by several universities, and engineering and science colleges.
Abstract:
Pioneered at Stanford University in the 1970s, the recombinant DNA technology has made possible the modern biopharmaceutical industry. Biotherapeutics have revolutionised the treatment of various life-threatening and chronic conditions, but they are very expensive and therefore remain out of the reach of millions across the world. As these products lose patent protection, follow-on biologics like biosimilars and biobetters are poised to drastically expand patient access by increasing affordability. India, already home to a robust generics industry, also has multiple players developing as well as manufacturing biosimilars for both the domestic and global markets. In order to identify potential biotherapeutics for biosimilar development, we manually annotated the US-FDA CDER and CBER lists, extracted biologics with therapeutic applications in humans, classified these on the basis of their patent status and biomolecule categories, and then checked which ones had comparable biosimilars in the Indian market. Since the objective was to use a microbial expression system, we further eliminated products with extensive post-translational modifications, and arrived at enzyme candidates like asparaginase, collagenase, and monoclonal antibody candidates like Ranibizumab. Asparaginase, indicated for the treatment of acute lymphoblastic leukemia, was expressed in E. coli, purified and was assayed in the CEL and Kasumi cell lines. Its physicochemical biosimilarity with the reference product was also established. In the next phase of our study, cysteine-specific PEGylation of the ranimizumab Fab’ fragment (expressed in E. coli) would be carried out in an attempt to develop a biobetter version of the same (PEGylation improves efficacy, stability and antigenicity).
Melissa Law,
Technology Catalysts International, USA
Title: Emerging biosimilars in the USA – quo vadis
Biography:
Abstract:
While the US biosimilar market has lagged behind Europe for almost a decade due to delays concerning the release of specific guidelines by the FDA, the market is poised for growth. Of the estimated size of $60 billion for the US biologics market in 2020, major products such as Lantus, Herceptin, Neulasta, Avastin, Rituxan, Remicade, and Humira will lose patent exclusivity thereby creating a significant market potential for biosimilars of these products in their respective therapeutic areas diabetes, cancer and autoimmune diseases like rheumatoid arthritis. This is expected to lead to the increased availability of lower priced treatment options for these conditions. Another wave of biologics will lose patent exclusivity between 2020 and 2025, potentially increasing the market size of biosimilars further. With an increased number of biosimilar options and a more well-defined regulatory pathway, US payers will strive to adapt to the changing market. US payers believe that biosimilars should be treated as low-cost branded products rather than generics, which can save the health care system billions of dollars by switching patients from originator drug products to biosimilars.