6^th International Conference and Exhibition on Biologics and Biosimilars October 19-21, 2016 Houston,Texas, USA

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, CinnoVex^TM 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.

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). 

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. 

Biography:

Dipti Gulati completed her Ph.D at the age of 25 years from Allahabad University and postdoctoral studies from Indian Institute of Sciences, India and Albert Einstein College of Medicine on Protein-Carbohydrate Interactions, USA. Currently, she is the President of PJI Biotech, a Consulting Services Organization. Previously, she held various Management Positions at Amgen, BioMerieux, Emergent Bio Solutions, Diosynth and SmithKline Beecham Pharmaceuticals. She has published more than 25 papers in reputed journals and is a member of PDA Regulatory and Quality Advisory Board

Abstract:

The UK decided to leave the European Union on 23 June2016, but will Brexit change Biosimilar market?  

One group believes that that Brexit UK will have a significant impact on Biosimilar market in UK because UK currently don’t have a regulatory pathway to approve Biosimilars. The approval process for Biosimilars is currently carried out through a Centralized procedure with the EMA. Additionally, none of the seven Biosimilars available in UK are manufactured locally. Brexit could result in disruption of supply chain, additional importation testing, additional recertification requirements after importing, new import/export charges and uncertainty regarding regulatory strategy.Others optimistic group pinpoints that the EMA is currently headquartered in London and relocation of the headquarter to other EU country will not happen soon. Furthermore, UK may not want Drug manufacturers to follow two separate regulatory pathways for Biosimilars. It is beneficial for both UK and EU to remain part of same regulatory scheme. How Brexit will impact regulatory pathway and approval of Biosimilars, is yet to be determined. Author will present the impact of Brexit on Biosimilar market.

Biography:

Dinesh Palanivelu has completed his PhD at the age of 29 years in the field of Structural biology from Biozentrum, University of Basel, Switerland and postdoctoral studies from University of California, San Francisco, Cardiovascular Research Insitute, San Francisco U.S.A. He is the Scientific Manager - Team leader in Analytical and Molecular Characterization Division, Biocon Research Centre, Biocon Limited, Bangalore, a premier Biopharamceutical Organization in India. He has published several particles in the field of Structural biology and Protein chemistry in internationally reputed journals.

Abstract:

Protein biopharmaceuticals become a major focus in biotechnology industry for treating various life-threatening diseases. Unraveling their structural complexity represents an biggest analytical challenge. In past decade, the state-of-the-art analytical tools have been developed to dissect primary and higher order structures, PTM modifications, purity and impurity profiles and pharmacokinetic properties to provide Structure-Activity Relationship (SAR), specifically in the field of biosimilars¹. Biosimilars are defined as follow-on-biologics that have been shown to have comparable quality, safety, and efficacy to the innovator products. Regulatory approval for a biosimilar version is provided on the basis of its comparability to an innovator product². The complexity of the manufacturing process, analytical methods, structural heterogenity and the possibility of severe immunogenicity reactions makes evaluation of similarity between an innovator and the biosimilar version a great challenge for the scientific community and regulatory agencies³.

Biosimilar development involves an iterative target-directed approach, driven by thorough understanding of the structure and its biological function of a target molecule. This includes understanding batch-to-batch consistency, stability, and whether variants or aggregates can be linked to safety and efficacy⁴. The role of Higher-Order-Structure (HOS) has become a major investigation tool for establishing Structure-Function relationship. Differences in HOS provides potential clues to any observed biological and/or immunological differences between proteins and variant forms. What is required to integrate HOS into existing biopharmaceutical processes? Will doing so prove worth the cost, time, and effort?

Here, we present the pleothera of HOS tools designed for biosimilar programs to understand the purity and impurity profiles to establish its SAR across several orthogonal analytical methods. Extensive HOS characterization datasets adds value to the totalilty of evidence which helps the regulatory agencies in the decision making process. In summary, the paradigm shift in structure-function relationship is the current requirement for global regulatory approvals for biosimilars.

Biography:

Ms. Laura Burson is a partner in the Intellectual Property Practice Group in  SHEPPARD, MULLIN, RICHTER & HAMPTON LLP’s Los Angeles office.  She is Co-Leader of the firm's Hatch-Waxman and Biosimilars Team.

Ms. Burson focuses on intellectual property litigation with an emphasis on patent law. She is a registered patent attorney, admitted to practice before the U.S. Patent and Trademark Office. Laura has experience in all phases of litigation, including trials, arbitrations, and appeals involving intellectual property and technology-related matters. Her clients come from a broad range of technology areas, including medical devices, chemicals and chemical processes, biotechnology, pharmaceuticals, computers, and other technologies. She is also active in pro bono matters and has served a volunteer prosecutor in criminal jury trials. She currently serves on the boards of directors of LAIPLA and Center for Civic Mediation.

Abstract:

In Amgen v. Sandoz, the Federal Circuit held that biosimilar applicants are not required to provide their Biologics License Application (BLA) or engage in the patent dance – the process under the BPCIA in which the parties identify which patents the parties believe should be litigated.  However, the court held that an applicant who fails to provide its BLA must provide the brand with 180-days’ notice of launch.  In Amgen v. Apotex, the Federal Circuit held that a biosimilar applicant must always provide the brand with 180-days’ notice before launch, regardless of whether the applicant provided its BLA or engaged in the patent dance.  The result of these decisions may be that few biosimilars applicants engage in the patent dance. 

Rather than litigating biologics patents under the BPCIA, biosimilars applicants may challenge biologics patents by filing IPRs.  We will review IPRs that have been filed in the biologics area, analyze key institution decisions, and provide takeaways from the institution decisions and our views on lessons that should be learned from these decisions.        

Biography:

Shimada T has completed his Ph.D. at the age of 38 years from University of Tsukuba. He is the R&D manager of Life Science Research Center, SHIMADZU Corporation. His career in SHIMADZU is from 2001, and has been participated in several project such as age-related liver proteomics, next generation mass spectrometry, collaboration with National Cancer Center Japan, and academic careers in several university. He has published more than 20 papers in scientific journals. His specialities are protein chemistry, proteomics, and bioanalysis by mass spectrometry.

Abstract:

Monoclonal antibodies have become a major therapeutic strategy in cancer care. The approved antibody drugs have been about 41 items, and many clinical trials including biosimilars have been now performing in the world. For precision medicine, pharmacokinetic (PK) information in blood or disease tissue will become one of the good indicators for drug efficacy. Therefore, versatile analysis for the direct detection of antibody drugs will be desired. The LCMS bioanalysis of antibody drugs is a significant platform for the selective quantitation of antibody specific region or the feasibility of multiplex assays. For a regulated LCMS bioanalysis independent of a variety of monoclonal antibodies or biological taxonomy sources, we have focused on the two features: antibody structure-indicated method, and complementarity-determining region (CDR)-targeting quantitation.

Minimizing peptide complexity while maintaining specificity of antibody signature peptides is essential for antibody LCMS bioanalysis. To the best of our knowledge, CDR-selective preparation in antibody proteolysis has never been investigated to date. We have reported a novel method for the Fab-selective proteolysis to identify and quantify antibodies by the limiting protease access to the substrate, which we have named nano-surface and molecular-orientation limited (nSMOL) proteolysis. nSMOL enables efficient and quantitative detection of CDR peptides while decreasing the peptide numbers of the analytical target without denaturation. We have reported several papers for fully validated bioanalysis of antibody drugs. This approach will be applicable for many monoclonal antibodies and biosimilar drugs. Furthermore, the clinical PK based on LCMS may be expected to aid acceleration of the development of biopharmaceuticals.