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9th Asian Biologics and Biosimilars Congress, will be organized around the theme “Biologics & Biosimilars: Power of the Past - Force of the Future”

Asian Biosimilars 2018 is comprised of keynote and speakers sessions on latest cutting edge research designed to offer comprehensive global discussions that address current issues in Asian Biosimilars 2018

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Formal legislation to ensure rigorous regulatory and testing standards for biosimilars (in place of the less regulated ‘copy biologics’) began to appear in 2008–2009, with Australia, Malaysia, South Korea, and Japan among the first countries in the region to implement these strict approval requirements. More recently, India (2012) and China (2015) have finalized their own national guidelines. There are currently more biosimilar products in development across the Asia-Pacific region than anywhere else in the world, leading to a wealth of opportunities for investors and patients to take part in biosimilar clinical trials. This track covers topics such as: 

  • Track 1-1Prospects of Biosimilars in Asian market
  • Track 1-2Approved Biosimilars in Asia-Pacific Region
  • Track 1-3Regulatory guidelines in the Asia-Pacific region
  • Track 1-4Market strategy, analysis and Risk Management for Biosimilars in Asia market
Asian Biosimilar 2018 will provide an excellent opportunity to the scientists, partners and pharma leaders from Biopharmaceutical and Biotechnology industries to discuss and learn about the regulatory competencies required for Biosimilars and Biologics.This track includes: Licensing of biosimilars, Biosimilars regulation, Biosimilar Patents , BLA filing for biosimilars, Regulatory prospects of BRIC countries, a paradigm of traditional generics to biosimilars, Biowaiver approval for Biosimilars.
Approximately 20% of the biologics and biosimilars in the  worldwide R&D pipelines are facing challenges to fall in line with the regulatory guidelines..
  • Track 2-1Regulatory prospects of BRIC countries
  • Track 2-2Licensing of biosimilars
  • Track 2-3BLA filing for biosimilars
  • Track 2-4A paradigm of traditional generics to biosimilars
  • Track 2-5Patent disputes and litigations
  • Track 2-6Generic Biosimilars
  • Track 2-7Critical regulatory issues

The biosimilars market is set to expand over the next decade and beyond as a result of two major factors: the impending patent expires on blockbuster biologics and the financial crisis that is driving payers to push for wider adoption of biosimilars to manage the escalating costs of healthcare. Although many companies are keen on getting a share in the biosimilars market given its promising outlook, bringing these complex molecules from bench to launch can be a challenge, not just during the development stage but also in terms of the manufacturing process involved. 

  • Track 3-1Equivalence of complex drug products
  • Track 3-2Unique considerations for biologics
  • Track 3-3Current concepts of drugs and biologics
  • Track 3-4Late clinical development essentials
  • Track 3-5Early clinical development essentials
  • Track 3-6Drug Safety essentials
  • Track 3-7Advertising, promotion and labeling essentials
  • Track 3-8Economic aspect towards biosimilars
  • Track 3-9Biosimilar monoclonal antibodies
  • Track 3-10Comparability for Biologics

The global biosimilars market is growing at an exponential rate. The CAGR from 2015 to 2020 is projected at over 22%. The biosimilars market is expected to be around $6.2 billion by 2020 from only $2.3 billion in 2015. By the end of this decade the biosimilars would surely occupy 27% of the total pharmaceutical market. Moreover, with the global rise in concern for more accessible-improved- cost effective healthcare, biosimilar drugs would be a more apt choice to the payers, end users, manufacturers over the costly reference biologics. Originator biologics are as costly as about $100,000 per year per patient. Biosimilars on the contrary can be offered at a 30-40% lower price than that of the reference product. However, with all the success stories and opportunities there also lies a sobering 50% failure rate in developing and obtaining license towards marketing of biosimilars.  The biosimilars market is categorized into mainly four zones – North America(USA and Canada); Europe(UK, Germany, Spain, Italy, France and Rest of Europe); Aisa-Pacific( China, India, Japan, South Korea) and rest of the world ( LATAM and MENA). Key players of the biosimilars market include Amgen, Hospira, Teva, Sandoz International GmbH, Dr. Reddy’s Laboratory, Biocon, Roche, Celltrion, Catalent, Mylan and Merck. There are also certain other companies which are gaining importance in biosimilar de​velopment like LeanBio Pro-Spain, PPD-USA, SGS Life Sciences-UK, Therapeutic Proteins International-USA. The biosimilars development is mainly concentrated in the therapeutic domains of oncology, blood disorders, autoimmune disorders, endocrine disorders and infectious diseases. 

  • Track 4-1Return on Investment(ROI) for Biosimilars
  • Track 4-2Biosimilars Pharmacoeconomic Modelling
  • Track 4-3CAGR of biologics and biosimilars
  • Track 4-4Future of next generation biosimilars
  • Track 4-5SWOT Analysis of Biosimilars
  • Track 4-6Challenging potential & Competing Vs Generics
  • Track 4-7Penetration and uptake of biosimilars in different disease sectors
  • Track 4-8Pharmacoeconomic Modelling of Biosimilars
  • Track 4-9Risk management plan (RMP) for Biosimilars

Drug related authorities such as European Medicines Agency (EMA), Food and Drug Administration (FDA), and Health Canada hold their own guidance on requirements for demonstration of the similar nature of two biological products in terms of safety and efficacy. According to them, analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components, animal studies (including the assessment of toxicity), and a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) are sufficient to demonstrate safety, purity, and potency in one or more.

As clinical trial data are usually insufficient to identify rare adverse effects, the general pharmacovigilance requirements applied to biosimilars are the same as those for any biological medicine. 

  • Track 5-1Current problems in pharmacovigilance
  • Track 5-2Role of pharma industries in the improvement of pharmacovigilance system
  • Track 5-3Detection and evaluation of drug safety signals
  • Track 5-4Adverse drug reactions with pharmaceutical products
  • Track 5-5Good pharmacovigilance practice and pharmacoepidemiology

A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products. Biosimilar innovative products are on the rise. The numbers of new drugs seeking approval are growing at a compounded rate of around 5% half early. Almost 1.5 times the number of biosimilars are expected to be in the market in 2017 compared to in the last 5 years.

  • Track 6-1Biotechnology medicinal products for different diseases/disorders
  • Track 6-2Biosimilars for Autoimmune diseases
  • Track 6-3Biosimilars in Dermatological diseases
  • Track 6-4Biosimilar antibodies
  • Track 6-5Biopharmaceuticals development
  • Track 6-6Future of next generation biosimilars

Global uptake of Biosimilars has led to the adoption of distinct legal and regulatory frameworks in different countries. Thorough understanding of the marketing strategies, newer analytical characterization techniques and proper communication between regulatory authorities and manufacturers may help to bring a biosimilars more easily in the global market.

South Korea was the first country worldwide to approve biosimilar versions of etanercept according to international standards. Australia is the world’s first highly regulated market to allow pharmacy level substitution of a monoclonal antibody biosimilar for an originator. As of April 2016; 8 biosimilars have been approved in Japan, including the recent approved insulin glargine biosimilar. A recent report has shown that biosimilars in India have witnessed nearly 20% annual growth for the last financial year and now make up for about 2.5% of the overall biologics market.

  • Track 7-1Global uptake of Biosimilars
  • Track 7-2Global impact of biosimilars over generics
  • Track 7-3Biosimilars in global market
  • Track 7-4Investment and returns on biosimilars
  • Track 7-5Cost and risk management
  • Track 7-6Adopting innovative mechanisms such as risk-sharing arrangement
  • Track 7-7Global P&R models for the biosimilars and generics market
  • Track 7-8Uniform Code for Biologics and Biosimilars Marketing Practices

Manufacturing processes for biosimilars stand on their own and need not duplicate the originator’s production methods. Instead, the focus is on extended characterization efforts to show that the biosimilar is ‘highly similar’ to the reference medicine. That can really cut clinical efforts and save developers a lot of money. There are also opportunities for greater process economy through improved production technology as, for example, through the implementation of single-use equipment, more rigorous process monitoring, process intensification, and other improvements.

Emerging trends suggest that Asia is attracting major investors interested in biosimilars industry; the growth prospects are driven by streamlining of regulatory guidelines and high adoption rate for biosimilars among physicians, payers and patients.

  • Track 8-1Biosimilars in Stem Cell Technology
  • Track 8-2Improving characterization of biosimilars with technology
  • Track 8-3Capacity for economic supremacy

In innovative drug development, three phases, and usually multiple studies per phase, of clinical research are required. In contrast, biosimilar clinical development can be abbreviated because of the breadth of understanding of the reference biologic and if the structural or functional similarity of the biosimilar has been preliminarily demonstrated analytically.  While clinical requirements differ by regulatory agency, in general, two phases of clinical studies are required – a Phase I study to demonstrate similar pharmacokinetics (how a medicine moves through the body) and a Phase II study of pharmacodynamics (effect of the medicine in the body), along with a pivotal study, referred to as Phase III, to demonstrate similar efficacy, safety and immunogenicity to the reference biologic.

  • Track 9-1Extrapolation of Indications in Biosimilars
  • Track 9-2Biosimilars Clinical Studies
  • Track 9-3Clinical trials on major diseases
  • Track 9-4Risk management and quality affairs
  • Track 9-5Case studies and clinical models
  • Track 9-6Transgenic animals
  • Track 9-7Targeted cell line development
  • Track 9-8Clinical PK/PD studies
  • Track 9-9Toxicological studies
  • Track 9-10Biosimilars Clinical Trials
  • Track 9-11Aspects of genotoxicity tests

A biosimilar medicine is developed to be highly similar to a biological medicine that is already approved and available for patients, once the original patent has expired.

It is predicted that as patents expire over the next five years for a number of biological medicines with high sales, the development of biosimilar medicines for the treatment of cancer, diabetes, rheumatoid arthritis and multiple sclerosis will be seen. It is also predicted that the monoclonal antibodies (mABs) will comprise a large proportion of the biosimilars market along with biosimilar insulins, which are also expected to enter the insulin landscape in the coming years as the patents for major insulin products begin to expire. The proportion of different biosimilars that reached market are Low Molecular Weight Heparins 44%, Epoetins 19%, HGH 11%, G-CSFs 7%, Interferons 6%, Insulins 5%, Others 8%.

  • Track 10-1Biosimilars in Cancer therapeutics
  • Track 10-2Biosimilars in rheumatology
  • Track 10-3Recombinant vaccines
  • Track 10-4Growth hormones
  • Track 10-5Insulin Biosimilars
  • Track 10-6Biosimilar peptides
  • Track 10-7Recombinant therapeutic proteins
  • Track 10-8Biosimilar monoclonal antibodies
  • Track 10-9Recombinant blood products
  • Track 10-10Biosimilars in Fertility Treatment
  • Track 10-11Biosimilar TNF-α
  • Track 10-12Biosimilar Epoetins
  • Track 10-13Biosimilar Interleukins
  • Track 10-14Biosimilars interferon

Analysis of Biosimilars and biologics forms to be one of the most important aspect towards the biologics and biosimilar development process. The development pathway of a biosimilar is unlike that of a novel biotherapeutic, requiring earlier extensive analytical characterization. Analysis of biosimilar and biologics takes the longest stretch towards establishing the product in comparison with the original product.

Any manufacturer seeking to develop and market a biopharmaceutical product requires comprehensive physicochemical structural characterization of the (glyco) protein. For biosimilar products, this task is magnified and forms the basis for further comparability. 

  • Track 11-1Biosimilar Bioanalytical methods
  • Track 11-2Biosimilar Formulation
  • Track 11-3Bioassay for comparability and potency testing
  • Track 11-4Biosimilar GMP protein analysis
  • Track 11-5Biosimilar LC/MS analysis for discovery, preclinical, and clinical programs
  • Track 11-6Biosimilar Electrophoresis
  • Track 11-7Biosimilar Multimodal techniques
  • Track 11-8Bioanalytical Challenges

The legal issues pertaining to the the follow-on-biologics and biosimilars are one of the most aspects that requires an open discussion. Before the actual advent of biosimilars to the market legal issues have risen in numbers in their developmental stages. Renowned organizations have filed cases against each other two claim their rights and for other legal allegations related to the products. This track is dedicated to discussion of all such cases which has been argued in the court of law.

By 2002, the FDA had approved 36 new biologics, followed by 37 more in 2003, another 40 in 2004 and 39 more in 2005. By 2006, the leading category of biologic treatment, the red blood cell enhancer recombinant erythropoietin (EPO), generated $14 billion in sales revenues, or 40 percent more than the best-selling traditional pharmaceutical, Lipitor. More than 300 therapeutic antibodies currently are in clinical development and trials, compared to just 13 that already are widely available due to legal issues.

  • Track 12-1Implimentation of the BPCI Act
  • Track 12-2Patent protection and infringement issues
  • Track 12-3Patent negotiation and litigation phase
  • Track 12-4Market exclusivities
  • Track 12-5Biosimilars pricing regulation
  • Track 12-6Criteria for Patentability and Patent Claims
  • Track 12-7Recent Patent disputes and litigations
 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.Currently, the US provides 12 years of exclusivity for new biological products under the Biologics Price Competition and Innovation Act (BPCIA).The provision providing 12 years exclusivity was buried inside the 20,000-page healthcare law. Eight years of exclusivity would keep biologic medicines out of the hands of many who need them. Prices frequently exceed $100,000.
  • Track 13-1Pharma Patent Scenario
  • Track 13-2Criteria for Patentability and Patent Claims
  • Track 13-3Critical research issues
  • Track 13-4Patentable subject matter
  • Track 13-5Recent Patent disputes and litigations
  • Track 13-6Evaluation of highly variable drugs and drug products

The Brexit effect on Biosimilars tends to be negative. Not only would it be a major setback towards approval and launch of biosimilars to the market but also it would be hindrance towards the cost cutting approach taken up by NHS.With Britain being among principal clinical trial centers is owned to see a decrease in the willingness of the manufacturers and researchers to carry out any further trials in Britain. Also Brexit will cause the principal motive of Bristish Biosimilars Association(BBA) to fall back- which aimed at increasing the use of biosimilars.

  • Track 14-1Brexit- Pros and Cons to European pharma market
  • Track 14-2Post Brexit changes in Biosimilars regulation in UK
  • Track 14-3Fate of biosimilars clinical trials in UK
  • Track 14-4Research funding from European organizations to UK based research laboratories

In the era of swelling costs of drug development and shrinking budgets, the pharmaceutical industry has been striving hard to find ways for saving precious resources. Tools evolved through naive scientific probing, like BCS (Biopharmaceutics Classification System) and IVIVC (invitro and invivo classification) can act as the magic-wands in such cases. Besides obtaining biowaivers, IVIVC has been applied in drug delivery during various stages of development, like formulation screening, setting dissolution specifications and product development. Nonetheless, the most critical pharmaco-economic application is the biowaiver by avoidance of expensive clinical trials. Newer paradigms like in vitro/in vivo relationship (IVIVR) are also being deliberated and practiced at industrial level, esp. for IR formulations.

  • Track 15-1BCS biowaivers
  • Track 15-2Preclinical and clinical testing for oral drug delivery
  • Track 15-3Waiver for In vivo bioavailability or bioequivalence
  • Track 15-4Consideration of biowaiver extensions for BCS class III drugs
  • Track 15-5In vitro diffusion cells for dissolution testing in formulation development
  • Track 15-6Dissolution testing in drug formulation
  • Track 15-7In vitro preclinical ADME/BCS testing
  • Track 15-8In vitro drug product research
  • Track 15-9Biowaiver approval for Biosimilars
Biologics market growth is still largely driven by mature markets. The global biologics market had reached $170 billion in sales value in 2012, accounting for 18 percent of the overall market. The five top 10 global products in terms of sales volume are biologics, wherein 2008 it was just two.
The market in the APAC region for biosimilars reached $605 million in 2010 and $683 million in 2011. The market is expected to reach $1.1 billion by 2016, a CAGR of 10.3%. The market in the United States for biosimilars reached $507 million in 2010 and $1.1 billion in 2011. The market is expected to reach $1.3 billion by 2016, a CAGR of 4.1%.

 

  • Track 16-1Biosimilars China and Asia Pacific
  • Track 16-2Biosimilars India
  • Track 16-3Biosimilars USA
  • Track 16-4Biosimilars Europe
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 dtug qualifies to be a suitable biologics or biosimilars.
  • Track 17-1Strategies for the bioequivalence assessment of topical dosage forms
  • Track 17-2Bioequivalence assessment of respiratory dosage forms
  • Track 17-3Bioequivalence approaches for transdermal dosage forms

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