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To exchange the knowledge in the field of biological transformation and biosimilars
- Biosimilars Congress 2019

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The Organizing Committee is pleased to welcome you for the forthcoming International Conference on Biosimilars one of its surprising Pharmaceutical gatherings, tobe held on October 23-24 in Tokyo, Japan. Biosimilars 2019 will unite researchers, analysts, business improvement chiefs, CEOs, executives, IP Attorneys, Regulatory Officials and CROs from around the world. Many biologics items are influencing their entrance in the Pharma to showcase and encountering an eminent ascent in their utilization over the ordinary drugs. Biosimilars 2019 meet your intended interest groups from around the globe concentrated on finding out about Biosimilars. This gathering would be your single best chance to achieve the biggest array of members from the Biosimilars group. The conference will also discuss pharmacovigilance, post-marketing surveillance,and post-approval clinical studies. Compliance with regulatory guidelines is riticalto the successful development and commercial launch for Biologics and Biosimilars.

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Biosimilars Conference is inviting you to attend Biosimilars Congress 2019 on October 23-24, 2019 Tokyo | Japan .The topic of the current year's gathering is Biosimilars & Biologics : Present Scenario & Future Prospects which will give a worldwide stage to talk of present and future of Biosimilars.

The Organizing Committee is satisfied to welcome you to attend the"International Conference on Biosimilars and Biologics",one of its astonishing Pharmaceutical gatherings to be held in October 23-24 | 2019 in Tokyo,Japan.

Our Conferences on Biosimilars joins scientists, authorities and CROs from around the world. The Biosimilars Congress 2019 experiences an exponential improvement over the coming couple of years. Various Biologics things are affecting their passage in the pharma to publicize and experiencing a striking climb in their utilization over the standard remedies.

Why to attend
Biosimilars Congress 2019 gives a complete 360-degree overview on Biosimilars and Biologics: Present scenario & Future prospects. Participants will leave the conference with a wealth of new information and an expanded network of contacts.
The Biosimilar is a lucrative sector owing to recent regulatory approvals and increasing opportunities. Biosimilars and Biologics are at different stages of evolution across the globe. Developing a Biosimilars demands huge investment, technical capabilities and clinical trial expertise. In order to unlock the Biosimilars potential, the industry will entail focused strategies along the whole value chain, from optimizing the clinical development program to commercialization.

Biosimilars Conferences programme delves into strategic discussions regarding

  • Current Challenges and Research trends in Biosimilars & Biologics
  • BCS & IVIVC Based Biowaivers
  • Biopharmaceutical
  • Biological Medicines
  • Developing Biosimilars & Biobetters
  • Generics and Biosimilars: Industrial Strategy
Target Audience:
Directors, CEO’s of Organizations, Business Development Managers, Chief Scientific Officers, R&D Researchers from Biosimilar and Biologics Industries, Professors, Associate Professors,Assistant Professors, PhD Scholars Patent , Attorneys, Intellectual Property Attorneys, Investment Analysts, Association presidents and professionals, Noble laureates in Health Care and Medicine, Bio instruments Professionals,Bio-informatics Professionals, Research Institutes and members, Supply Chain companies, Manufacturing Companies, Business Entrepreneurs

2019 Highlights:

  • 300+Participation (70 Industry: 30 Academia)
  • 10+Keynote Speakers
  • 50+Plenary Speakers
  • 20+Exhibitors
  • 5+Workshops

Motives to attend:

  • Keynote presentation along with interactions to galvanize the scientific community.
  • Workshop and symposiums to reach the largest assemblage of participants from the Pharma/Biotech community.
  • A wide track of exhibitors to showcase the new and emerging technologies.
  • Platform to global investment community to connect with stakeholders in Pharma/Biotech sector.
  • Young Scientist/ Investigators Award geared towards best budding young research.
  • Links to the political marketing resources in order to expand your business and research network.
  • Triumph of Awards, Certificates recognizes your commitment to your profession to encourage the nascent research.


        Biologics & Biosimilars Analytical Strategies:
        Analysis of biosimilars and biologics forms to be one of the most important aspects towards the biologics and biosimilar development process. Biosimilars analytical methods for process development and validation as well as use of production technologies such as disposables and supply chain logistics can help companies establish facility flexibility. This biosimilars global event also includes Bio-analytical methods, Formulation, Bioassay for comparability and potency testing, GMP protein analysis, LC/MS analysis for discovery, preclinical, and clinical programs. 

        Biosimilars in Oncology and Rare Diseases:
        Over the past two decades, the United States and Europe experienced a dramatic and unsustainable rise in cancer health care costs. Eight of the top ten most expensive drugs are cancer drugs, notably the novel biologic agents arising out of the recent revolution in our understanding of the genetic and molecular basis of malignancy. The demonstration of comparable efficacy and safety to the originator is a challenge for both regulators and companies, necessitating careful pharmacovigilance following approval. 

        Generics and Biosimilars
        Patents for several biologic blockbusters will expire in the next few years. The arrival of biosimilars, the biologic equivalent of chemical generics, will have an impact on the current biopharmaceuticals market. Five core capabilities have been identified as paramount for those companies aiming to enter the biosimilars market: research and development, manufacturing, supporting activities, marketing, and lobbying. Understanding the importance of each of these capabilities will be key to maximizing the value generated from the biologics patent cliff. This biosimilars conference will look at the facets of current challenges in biosimilar development. This biosimilar conference will focus on multiple aspects of biosimilar product development to successfully deliver safe, potential and efficacious biologic products to the market.

        Bioavailability and Bioequivalence
        In pharmacologybioavailability (BA or F) is a subcategory of retention and is the portion of a managed measurement of unaltered medication that achieves the fundamental dissemination, one of the essential pharmacokinetic properties of medications. By definition, when a pharmaceutical is directed intravenously, its bioavailability is 100%. Be that as it may, when a prescription is directed through different courses, (for example, orally), its bioavailability generally TH diminishes (because of inadequate assimilation and first-pass digestion) or may shift from patient to quit. Bioavailability is one of the fundamental instruments in pharmacokinetics, as bioavailability must be considered while ascertaining measurements for non-intravenous courses of the organization.

        Bioequivalence is a term in pharmacokinetics used to survey the normal in vivo natural proportionality of two restrictive arrangements of a medication. In the event that two items are said to be bioequivalent it implies that they would be required to be, in every practical sense, the same. Two pharmaceutical items are bioequivalent on the off chance that they are pharmaceutically proportional and their bioavailability (rate and degree of accessibility) after organization in a similar molar measurement are like such an extent, to the point that their belongings, regarding both viability and wellbeing, can be relied upon to be basically the same. Pharmaceutical equality infers a similar measure of a similar dynamic substance(s), in a similar dose shape, for a similar course of organization and meeting the same or tantamount benchmarks. 
        • In vitro Bioequivalence
        • Clinical trial formulations
        • Therapeutic index
        • Generic drugs
        • Bioequivalence of endogenous substances 

        Biologics v/s Biosimilars:
        Development of biologics is considerably more expensive and time-consuming than that of small molecules. The latter contain only carbon, oxygen and nitrogen, which are easier to synthesize with low batch-to-batch variability. Despite the high cost of development, due to their targeted nature with high efficacy, biologics are now taking on an increasingly important role in the treatment of common and/or serious diseases. To be called a biosimilar, these compounds need to demonstrate structural and functional similarities with comparable pharmacokinetic and pharmacodynamics properties to the originator compounds using sensitive indicators, for example, levels of cytokines, blood glucose or white cell counts.

        Statistical Approaches to Quality Comparability
        FDA’s guidance on comparability protocols discusses the need and considerations for assessing any product or process change that may impact safety or efficacy of a drug product or drug substance. Areas to consider may include:
        • Changes to the manufacturing process
        • Changes to the analytical procedure or analytical method
        • Changes in manufacturing equipment
        • Changes in location or manufacturing facilities
        • Changes to container closure systems
        • Changes in materials, concentrations, and/or formulation
        • Changes in Process analytical technology (PAT) or process controls
        • Any change that may influence safety or efficacy of the product.

        Bioequivalence Assessment for Biologics & Biosimilars
        Bioequivalence focuses on the equivalence of release of the active pharmaceutical ingredient from the pharmaceutical product and its subsequent absorption into the systemic circulation. This session has utmost importance in context to the fact that only a suitably bioequivalent drug candidate that conforms the results in all respects to the original licensed product can be called as biosimilar drug. Of all attempts towards developing a follow on biologics or a biosimilar drug the main detection point stands at the bioequivalence assessment. Once the bioequivalence has been obtained it can be 70% ascertained the drug qualifies to be a suitable biologics or biosimilars.

        Biosimilars Vs Bio betters
        Some evidence points to the fact that the first biosimilars were not as good as their branded counterparts. Whereas in case of Biobetters gain in effectiveness may come with a larger price tag, as the drug would be touted as an improvement on the current standard of treatment, and not a direct competitor in the market. This does nothing to help the cost-conscious consumer looking for cheaper alternatives.  Now the question arise Biosimilars or Biobetter? Accessibility & similarity or efficacy & improvement what will you choose?

        Clinical trials of Biologics & Biosimilars
        Biologic Trials require a customized approach based on the therapeutic indication and study specific goals. The CRO must work with the sponsor to develop an effective plan and execution strategy for these study types that includes subject recruitment, regulatory, clinical safety monitoring, specialized pharmacy expertise, and bio analytical support while ensuring subject safety throughout the entire trial. This is best accomplished with a detailed risk assessment to ensure all the bases are covered. The risk assessment isn’t just done once and then forgotten, but is a living document that is updated as new information about the molecule is gathered.

        GMP and QC
        Good Manufacturing Practice is that part of quality management which ensures that products are consistently produced and controlled according to the quality standards appropriate to their intended use and as required by the marketing authorization, clinical trial authorization or product specification. Good Manufacturing practices aims at both production and Quality Control. Fact about Current Good Manufacturing Practices (cGMP) is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products. Over the previous decade, a developing offer of the business' R&D yield has comprised of incremental enhancements to existing generic medications instead of new sub-atomic substances. Execution measures that consider just altogether new medications, for example, the quantity of NME endorsements every year miss that move and underestimate the business' R&D Field.

        Innovative Clinical Approach in Biosimilars:
        Clinical trials for biosimilars must exhibit practically identical security what's more, viability to the reference item, including consecutive PK/ PD and viability/security trials. Controllers expect PK/PD similarity information from a Phase I trial will bolster encourage viability/ well being evaluations in crucial Phase III trials. Remain solitary Phase III investigations or joined Phase I/III outlines without supporting PK information are probably not going to be acknowledged. Clinical similarity prerequisites may fluctuate on a case-by-case premise subject to a risk based approach. Three-arm Phase I trials are progressively being used to show equivalence between the biosimilars and two authorized adaptations of a similar reference item that may exist in various markets, allowing developers to proceed with pivotal trials using a single version of the reference product.

        Biosimilars Approval to Biogenerics in Clinical Practice
        Biological medicines are much more structurally complex and extremely sensitive to manufacturing conditions and therefore more difficult to characterize and produce than small molecule drugs. Even minor changes in manufacturing may lead to significant variations of the cellular systems used for biological production, as well as to differences in the structure, stability, or other quality aspects of the end product, all of which have the potential to affect tolerability and/or efficacy and increase the risk of immune responses. Owing to these issues, specific regulatory guidance on biosimilars is continuously evolving, and there is some disagreement on which studies need to be implemented to approve a biosimilars. According to current literature, the following points on biosimilars deserve consideration: Biosimilars development is characterized by global harmonization, although several not fully answered questions remain regarding extrapolation of indications, switching or interchange ability, and tolerability; in patients with rheumatic diseases, the tolerability and efficacy of biosimilars in clinical practice remain to be established; several medical and patient associations have published position papers on biosimilars requesting that safety, efficacy, and traceability be carefully considered; long-term post marketing studies should be implemented to allow physicians to gain confidence in biosimilars.

        Regulatory Approach for Biosimilars
        Biosimilars are the generic version of biological. It is the new buzz word in pharmaceutical industry. Biosimilars are highly similar to licensed reference product not withstanding minor differences in clinically inactive components; also there are no clinically meaningful differences between the biologicals and the reference product in terms of safety, purity, and potency. This track includes: Licensing of biosimilars, Biosimilars regulation, Patent issues, BLA filing for biosimilars, Biosimilars regulatory prospects of BRIC countries, a paradigm of traditional generics to Biosimilars, Biowaiver approval for Biosimilars and other aspects of Biosimilar approvals. Biosimilars 2019 will provide an excellent and global opportunity to the scientists, partners and pharma leaders from Biopharmaceutical and Biotechnology industries to innovate and to explore the strategic market for Biosimilars and Biologics with a clear picture of the regulatory approach for biosimilars and biologics.

        Challenges in Pharmacovigilance
        This session of the Biosimilars 2019 will be looking into the future and FDA initiatives that have already been announced to include enhanced tracking and follow-up of post market issues, planned improvements in AERS, and pilots of new post market drug-monitoring strategies. Current challenges in pharmacovigilance, Adverse drug reactions with pharmaceutical products, Biosimilar guidelines for pharmacovigilance practice and pharmaco epidemiology are the points that shall be laid emphasis in this session.

        Intellectual Property Rights
        The safeguarding of product trade secret, its formulations and other process parameters by law is usually covered by IPR. It includes those as patents, copyrights, industrial design rights, trademarks etc. IPR is of prime importance in the field of biologics and biosimilars. Most scientist and industries tend to retain their monopoly business by exercising the IPR. The very name Biosimilars calls for the occurrence of Intellectual Property rights laws and by-laws. Hence this session is of utmost interest to the attorneys and law personnel.

        A biopharmaceutical is also known as a biological medical product. It is any pharmaceutical drug product which is manufactured in, extracted from, or semi-synthesized from biological sources. They are different from totally synthesized pharmaceuticals. They include vaccines, blood and blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living cells used in cell therapy.

        Globalization of Biosimilars
        This track discuses about the generic drugs impact on global biosimilar market , Cost and risk management, Adopting innovative mechanisms such as risk-sharing arrangement, European market for biosimilars. The global market scenario with the launch of first biosimilar in the market forecasts some radical changes. This track will look upon such key concerns which are witnessed by the global pharma market and that are coming up with the subsequent launch of the other biosimilars and biologics. Despite these emerging facilities, biotherapeutic developers are most comfortable off-shoring to established markets—the US and Europe.

        Contract Research Organizations:
        A Contract research organization (CRO) is an organization that offers help to the pharmaceutical, biotechnology, and medicinal gadget businesses as research administrations outsourced on an agreement premise. A CRO may give such administrations as biopharmaceutical improvement, biologic examine advancement, commercialization, preclinical research, clinical researchclinical trial administration, and pharmacovigilance. CROs are intended to diminish costs for organizations growing new meds and medications in specialty markets. They plan to rearrange section into sedate markets, and streamline advancement, as the requirement for extensive pharmaceutical organizations to do everything 'in-house' is currently repetitive. CROs additionally bolster establishments, explore foundations, and colleges, notwithstanding legislative associations. Numerous CROs particularly give clinical-contemplate and clinical trial help for drugs as well as restorative gadgets. CROs extend from expansive, universal full-benefit associations to little, specialty forte gatherings. CROs that have practical experience in clinical trial administrations can offer their customers the aptitude of moving another medication or gadget from its origination to FDA/EMA promoting endorsement, without the medication support keeping up a staff for these administrations.
        • Pre-clinical trial
        • Clinical trial
        • Types of services provides
        • Quality control
        • Quality assurance
        • Good clinical practice

        Biosimilars Development
        Biosimilars being referred to as follow on Biologics calls for overcoming many challenges while it’s development. As comparisons are being drawn from the initial stages, it is very important to have proper scientific as well as strategic approached taken for the successful development of these Biosimilars. This need for overcoming the challenges continues till the late clinical steps, drug safety factors and labeling requirements.

        Market Analysis

        Research Organizations

        Applied Sciences


        Helmholtz Association

        Leibniz Association

        Max Planck Society

        Academies of Science

        Federal Research Institutes

        Laender Research Institutes

        Research Funding
        Funding for the policy mission oriented R&D for projects in the fields of life sciences, environment, energy, materials and nanotechnology, ICT, frontier fields, manufacturing, and social infrastructure comprises the bulk of public research funding. 

        In 2009 this was €14b and is funded by through the ministries and research funding organisations. Other types of funding, totaling €1.3b is for competitive projects. 

        The three main funding organisations in Japan are the Japan Society for the Promotion of Science (JSPS), the Japan Science and Technology Agency (JST), and the New Energy and Industrial TechnologyDevelopment Organisation (NEDO).  

        The JSPS and JST principally fund academic research, the JSPS chiefly in a "bottom-up" fashion, whilst the JST selects topics and issues calls in those areas, mostly in academic areas that may be of benefit for technology development. NEDO, which funds industrial R&D through networks and partnerships, largely operates along similar lines to the JST in how it issues calls and determines research projects. 

        Japan’s pharmaceuticals market ranks 3rd globally, and is growing at a compound annual growth rate (CAGR) of 3.4%.

        The Japanese government has positioned healthcare as a growth industry, and has made the creation of technologies and services, and development of the supporting infrastructure as part of its growth strategies. To achieve these goals, the necessary regulations are also being developed.

        While biopharmaceuticals account for around 30% of overall global drug sales, the products only make up 10% of sales in Japan. As such, rapid growth is projected for the Japanese biopharmaceutical market.

        The biosimilars market is also a rapidly growing one, with a variety of products currently under development.


        Market Entry Opportunities for Foreign Companies

        Over 70% of approved biopharmaceuticals in Japan are provided by foreign companies, indicating their status as major players in the domestic market.

        From among the 10 biosimilars approved in Japan by July 7, 2017, four are products developed by foreign companies.

        Foreign pharmaceutical companies entering the market could form development or manufacturing partnerships with domestic drug companies and research institutions.

        There are over 70 CRO/SMOs in Japan supporting new foreign players in carrying out the necessary clinical trials and approval procedures.

        Foreign companies can achieve smooth entry into the Japanese market in several ways, including shortening clinical trial periods by joining global clinical trials, using CROs to lessen the burden of drug approval procedures, and developing high value-added drugs which are not subject to Japan’s biennial pricing revisions.

        Business Environment in the Biopharmaceutical and Biosimilars Market

        Financial support for orphan drugs, tax breaks, and subsidies are available to new entrants in the market.

        The strong potential for drug discovery in Japan has seen the formation of numerous bio clusters that include worldclass universities with cutting-edge technologies and know-how.

        Biopharmaceutical and biosimilar-related events are held throughout the year, providing chances to find out about

        trends in the Japanese market and meet with potential partners. Related trade associations are also working to further develop the biopharmaceuticals industry

        Why Japan?

        Japan is also called as Land of Rising Sun. It is a stratovolcanic archipelago consisting of about 6,852 islands. The four largest are Honshu, Hokkaido, Kyushu, and Shikoku, which make up about ninety-seven percent of Japan's land area and often are referred to as home islands. The country is divided into 47 prefectures in eight regions, with Hokkaido being the northernmost prefecture and Okinawa being the southernmost one. The population of 127 million is the world's tenth largest, of which 98.5% are ethnic Japanese. 90.7% of people live in cities, while 9.3% live in the countryside.About 13.8 million people live in Tokyo, the capital of Japan. The Greater Tokyo Area is the most populous metropolitan area in the world with over 38 million people.

        Researchers at the University of Tokyo strive to carry out world-class research in pursuit of academic excellence and to contribute to the accumulation and diversity of human knowledge. By active translation of research results to society, the University of Tokyo aims to support deeper and broader understanding of our research activities within society in general, and to contribute to the realization of peaceful and fair international and local societies.

        Organizing Committee
        OCM Member
        Dr. Joel I. Osorio
        RegenerAge Clinic
        Mexico, Mexico
        OCM Member
        Dr.Ahmed G Hegazi
        Professor, Microbiology and Immunology
        National Research Center
        Cairo, Egypt
        OCM Member
        Dr. Michael MUENZBERG; M.D
        Consultant, Biosimilars
        Biosimilars Consulting CH
        Lausanne, Switzerland

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