International Conference on
Biosimilars and Biologics

 Theme  :  The Present Scenario and Future Prospects of Biosimilars & Biologics

  April 20-21, 2020

 Dubai, UAE

 Conference Brochure  Abstract Submission  Organizing Committee  Conference Program

ICBB-2020

Coalesce Research Group invites all pharmaceutical and Medical researchers, professionals, faculties and students the from across the globe to attend International Conference on Biosimilars and Biologics” during April 20-21, 2020 at Dubai, UAE which includes keynote presentations from highly affiliated personalities, Oral talks, Poster presentations and Exhibitions.

ICBB-2020 focuses upon “The Present Scenario and Future Prospects of Biosimilars & Biologics”.  This biologics  meeting focuses on the trends which the biosimilar markets is heading on since its launch till the present date and moving on to the projections in future. It takes into its fold the critical developmental procedures, analyses, regulatory factors and also pharmacovigilance including post marketing surveillance and clinical studies. Innovation and compliance to regulatory guidelines are the most critical aspects towards biosimilars and follow on biologics development and successful launching to the market.

Target Audience: 

  • Students, Scientists, Researchers, and Faculty of Pharmaceutical Sciences
  • Universities, Medical Colleges, Researchers from Pharmaceutical backgrounds
  • Pharma Industry, Pharmacy Associations and Societies,
  • Business Entrepreneurs, Training Institutes, Software developing companies,
  • Medical Devices Manufacturing Companies, CRO
  •  Data Management Companies.

Current Challenges in Developing Biosimilars and Biologic

The regulatory process for biologic agents, with approval depending most heavily on demonstration of safety and efficacy in clinical trials, regulatory review of biosimilars focuses on molecular characterization and preclinical studies and pharmacokinetic and pharmacodynamic studies to establish biosimilarity, with additional studies assessing immunogenicity and other potential toxicities; clinical trials are performed if uncertainty remains regarding safety and efficacy of the biosimilar. As noted by the authors, often 50% or more of the data in applications for approval of biosimilar agents concern manufacturing processes. Further, the regulatory approval process for biosimilars does not require the performance of clinical trials across all approved indications of the reference drug; with approval, a biosimilar drug may have labeling that is identical to that of the reference product across multiple indications. Thus, as noted by the authors, clinician appraisal of and confidence in biosimilars will initially depend less on large clinical trials than on preclinical and pharmacologic data establishing bioequivalence and on their own clinical experience. In the absence of data from large clinical trial programs, there is also uncertainty regarding how biosimilars can be integrated into evidence-based clinical practice guidelines

Emerging Biosimilars in Therapeutics

Innovator biologics have no doubt proven efficacy, safety and have contributed to several unmet medical needs, however high costs and affordability of these drugs cannot be discounted. As the patents and exclusivity for many biologics are expiring, this has created the huge opportunity for the development and approval of biosimilars for many biopharmaceutical players including innovator generics and biotech companies. The Global Biosimilars market is expected grow at 23 % CAGR over 2017-2023, from USD 4.10 Billion in 2017 to USD 14.23 billion by 2023.

The emerging biosimilar products are recombinant blood products, therapeutic proteins, vaccines, growth hormones, biosimilar peptides, therapeutic proteins, monoclonal antibodies (mAbs) etc. Biosimilar insulins are the most expected ones in the class to enter the biosimilar landscape as patents for major branded insulin products start to expire in the next few years.

Biosimilars Analytical Strategies

The generation of analytical data for the comparison between a biosimilar and the originator product is the initial assumption in the development of biosimilars.

Achieving biosimilarity can be a controversial and complex topic when deciding on the right time point and range of analytics. Protagen Protein Services (PPS), with 20 years of market experience in protein analytics and over 500 customer projects successfully completed, guides you as your pilot and analytical service provider in your efforts, offering a stepwise approach to all aspects of analytical characterization combining structural, physical and functional data in order to provide a meaningful assessment of biosimilarity.

Regulatory Approach for Biosimilars

Developing new biologics has led to regulations and norms aimed at guaranteeing their safety, quality and effectiveness, in terms of marketing, prescription, use, interchangeability and switching. Biologics are of great importance in treating patients suffering from rheumatic, autoimmune, inflammatory and neoplastic diseases. The expiry/lapse of reference biologics or originators' patents has meant that developing biosimilars involves accompanying legal requirements for their approval in countries worldwide. The main concept of this conference has thus approached the situation of biosimilar regulation worldwide, the pertinent technical concepts and regulatory differences in some countries of interest.

  • Licensing of biosimilars
  • Biosimilars regulation
  • BLA filing for biosimilars
  • Regulatory prospects of BRIC countries
  • A paradigm of traditional generics to biosimilars
  • Biowaiver approval for Biosimilars
  • Generic Biosimilars
  • BLA filing for biosimilars

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.

Biosimilars Role in Oncology and Gastroenterology

Cancer therapy has evolved significantly with increased adoption of biologic agents. When the patent on the cancer drug trastuzumab (Herceptin) expires next year, patients who have been receiving this biological therapy will have another treatment option: a biosimilar drug—a drug that is very similar, but not identical, to trastuzumab. The escalating cost of cancer care is placing an increasing burden on healthcare systems worldwide, largely a result of expensive biologic therapies

Biotherapeutic agents, also known as biologics, are large complex molecules that are produced in living systems. Biologics comprise a range of molecules with varying complexities, including peptides, such as human insulin; small proteins, like erythropoietin; and large molecules, including monoclonal antibodies.2 The use of biologics in the field of gastroenterology is largely confined to the treatment of the immune-mediated inflammatory bowel diseases (IBD), such as ulcerative colitis (UC) and Crohn’s disease (CD).

Biologics and Biosimilars in inflammatory bowel disease

There is no cure for inflammatory bowel disease (IBD), its symptoms can be treated and remission induced using biological medicines, including the anti-TNF (tumour necrosis factor) drug infliximab. Biosimilars of infliximab have been made available in guidelines from the British Society of Gastroenterology and the National Institute for Health and Care Excellence, and they represent a considerable cost-saving opportunity for the NHS. The potential difficulties of switching infliximab to a biosimilar at a hospital can be overcome with a two-step implementation process.

Biosimilars vs Biologics

Biologics or biological products are medicines made from living organisms through highly complex manufacturing processes and must be handled and administered under carefully monitored conditions. Biologics include a wide variety of products such as gene and cell therapies, therapeutic proteins, monoclonal antibodies, and vaccines. Biologics are used to prevent, treat or cure a variety of diseases including cancer, chronic kidney disease, diabetes, cystic fibrosis, and autoimmune disorders.

A biosimilar is exactly what its name implies — it is a biologic that is “similar” to another biologic medicine (known as a reference product) which is already licensed by the U.S. Food and Drug Administration (FDA).

Biosimilars vs Generics

Biosimilars are not the same as generic therapies. The term “generic” has a precise meaning when it comes to medications – it is limited to small-molecule medications made from synthesized chemicals with a fixed number of atoms and a known chemical structure. A generic must be chemically identical to its branded counterpart and contain the same active ingredients. Biosimilars are much larger molecules derived from living cells, making them challenging to develop and manufacture. A biosimilar also must demonstrate no clinically meaningful differences in efficacy, safety, and potency with its reference product

Biologics as therapeutics

Over the last 25 years many biological therapeutics have been approved for clinical use, and many of these for diseases where there was no other available therapy. There has been an evolution over this time period from proteins intended to be ‘nature identical’ to the development of engineered products and use of novel protein scaffolds intended to confer a pharmacokinetic, pharmacodynamic or other advantage over the natural counterpart. In addition, protein engineering has allowed the development of monoclonal antibodies as highly potent modulators directed at specific peptides/proteins.

Immunogenicity of Biosimilars

The first anticancer biosimilars have entered clinical use, with many others under clinical development. Like all biologics, biosimilars may elicit unwanted immune responses that can significantly impact clinical efficacy and safety. Head-to-head immunogenicity assessment of biosimilars and their reference biologics should, therefore, be a critical component of a biosimilar's clinical development program. Various bioanalytical platforms may be used to detect and characterize immune responses, each having relative strengths and weaknesses. To fully recognize the clinical relevance of such data, regulators must be able to interpret immunogenicity results in an assay-specific context as well as in perspective of clinical pharmacology, efficacy and safety

Intellectual Property Rights

Industrial property (IP) rights are extremely important for the pharmaceutical industry. The use of the IP system by SMEs in the pharmaceutical industry depends largely on the business strategy of a company, its size, resources, innovative capacity, competitive context and field of expertise. Research-based, innovation-led companies that seek to develop new drug, improve or adapt existing drugs or develop new pharmaceutical/medical equipment or processes, tend to rely heavily on the patent system to ensure they recover the investments incurred in research and development. Companies that rely on licensing in or licensing out of pharmaceutical products will need to be knowledgeable about the patent system to so that they are able to negotiate fair and balanced licensing contracts.

Monoclonal Antibody and Fusion Protein Biosimilars

Regulatory efforts to formalize guidance policies on biosimilars, there remains a need to educate healthcare stakeholders on the acknowledged definition of biosimilarity and the data that underpin it. A number of biologics are fusion proteins in which the extracellular domain of a receptor has been fused with the Fc region of an immunoglobulin, usually a human IgG1, to generate a soluble form of the receptor. Etanercept is the best recognized example in rheumatologic practice because it is a soluble form of the p75 tumor necrosis factor (TNF) receptor that can bind and neutralize TNF Fusion proteins are relatively simple to design and can exploit the ligand redundancy of certain receptors, providing a broader specificity than antiligand or antireceptor mAbs.

BCS and IVIVC Based Biowaivers

This work was to suggest the biowaiver potential of biopharmaceutical classification system (BCS) Class II drugs in self-microemulsifying drug delivery systems (SMEDDS) which are known to increase the solubility, dissolution and oral absorption of water-insoluble drugs. Cyclosporine was selected as a representative BCS Class II drug. New generic candidate of cyclosporine SMEDDS (test) was applied for the study with brand SMEDDS (reference I) and cyclosporine self-emulsifying drug delivery systems (SEDDS, reference II). Solubility and dissolution of cyclosporine from SMEDDS were critically enhanced, which were the similar behaviors with BCS class I drug

  • BCS biowaivers
  • Preclinical and clinical testing for oral drug delivery
  • Waiver for In vivo Bioavailability or Bioequivalence
  • Consideration of Biowaiver extensions for BCS class III drugs
  • In vitro diffusion cells for dissolution testing in formulation development
  • Dissolution testing in drug formulation
  • In vitro preclinical ADME/BCS testing
  • In vitro drug product research

Biosimilars Companies and Market Analysis

Biosimilars provides separate comprehensive analytics for the US, Japan, Europe, and Rest of World. Annual estimates and forecasts are provided for the period 2015 through 2022. Market data and analytics are derived from primary and secondary research.

Several blockbuster biologic drugs of major pharmaceuticals companies, such as Remicade, Rituxan, Herceptin, Enbrel, Lantus, and others expired. In the coming decade, there would be a rise in the patent expiration of several existing biological drugs, such as Erbitux, Avastin, Orencia, and others, which would provide an opportunity for many innovator companies as well as generic manufacturers to offer services, specially tailored toward biosimilars

Legal Issues and BPCI Act

The BPCIA established a licensure pathway for competing versions of previously marketed biologics. In particular, the legislation established a licensure pathway for competing versions of previously marketed biologics. In particular, the legislation established a regulatory regime for two sorts of follow-on biologics,termed ”biosimilar” and “interchangeable” biologics. The Food and Drug Administration (FDA) was afforded a prominent role in determining the particular standards for biosimilarity and interchangeability for individual products.

Finally BPCIA created a patent dispute resolution procedure for use by brand- name and follow-on biologic manufacturers

Biosimilars research pipelines

The biosimilars pipeline is progressing rapidly and continues to grow, with more products and more organizations involved. This article reviews the current biosimilars development pipeline and updates the industry’s progress. Quite a lot has changed in just one and a half years, and it still is early in the evolution of biosimilars, with more progress and changes coming.

Bioequivalence assessment

Bioequivalence studies conducted either during the development of the drug or after its marketing will be presented or discussed: Bioequivalence of highly variable drugs with the associated problem of widening the acceptance range or alternative solutions. Bioequivalence for investigating the food effect. Bioequivalence in special population such as children, non-Caucasian population. Bioequivalence based on in vitro data or literature. New approaches in bioequivalence interpretation. Bioequivalence and analytical methods which are not sensitive or specific enough.

Biopharmaceuticals and Biotechnology

Biopharmaceuticals are produced in living cells. They consist of human proteins, such as antibodies, hormones and cytokines, fragments thereof and other substances. The large majority of biologicals are produced in special cells, which are genetically modified and grown in special fermentors. Biotherapeutics differ in many ways from conventional (chemically produced) medicines, for example in manufacturing techniques, molecular size and complexity, stability of molecules and clinical properties.

Biotechnology is any technology that’s based on biology. Products that use living systems and organisms qualify as biotechnology. For thousands of years, the earliest farmers produced food and bred crops by utilizing a form of biotechnology.

Current Trends in Pharmaceutical industry

By 2020 the current role of the pharmaceutical industry’s sales and marketing workforce will be replaced by a new model as the industry shifts from a mass-market to a target-market approach to increase revenue. Global pharmaceutical markets are in the midst of major discontinuities. While growth in developed markets will slow down, emerging markets will become increasingly important in the coming decade. The Indian pharmaceuticals market, along with the markets of China, Brazil and Russia, will spearhead growth within these markets.

Biosimilars in Rheumatology and Dermatology

The treatment of rheumatic diseases have acknowledged that biosimilars and biologic DMARDs (bDMARDs) are interchangeable in clinical practice, except when patients experience lack of efficacy or tolerability with the reference agent. Given that cost is a barrier to effective bDMARD use, the introduction of less costly biosimilars is likely to widen access and dissipate treatment inequalities. Physicians faced with prescribing decisions should be reassured by the robust and exhaustive process that is involved in assuring comparability of biosimilars with their reference agents. De novo usage of a biosimilar and switching to a biosimilar following lack of efficacy or tolerability with a different reference biologic agent are likely to be strategies most easily adopted, although switching during successful treatment should also be considered given the potential cost implications.

Opportunities for Conference Attendees:

For Researchers & Faculty:

  • Speaker Presentations
  • Poster Display
  • Symposium hosting
  • Workshop organizing

For Universities, Associations & Societies:

  • Association Partnering
  • Collaboration proposals
  • Academic Partnering
  • Group Participation

For Students & Research Scholars:

  • Poster Presentation Competition (Winner will get Best Poster Award)
  • Young Researcher Forum (Award to the best presenter)
  • Student Attendee
  • Group Registrations

For Business Speakers:

  • Speaker Presentations
  • Symposium hosting
  • Book Launch event
  • Networking opportunities
  • Audience participation

For Companies:

  • Exhibitor and Vendor Booths
  • Sponsorships opportunities
  • Product launch
  • Workshop organizing
  • Scientific Partnering
  • Marketing and Networking with clients

Abstract Peer-review Process/Guidelines:

  • The Reviewing Committee of Biosimilars Conferences ensures high-quality peer review process for all abstracts submitted to the conference.
  • The decision of abstract acceptance will be judged by a panel of experts emphasizing whether the findings and / or conclusions are novel and make useful contributions to the field.
  • The committee operates a single / double-blind peer review process for all the abstracts submitted, where both the reviewer and the author remain anonymous.

The following are the steps that each abstract of Biosimilars Conferences undergoes during the process of peer review:

  • All submitted abstracts are reviewed by internal editorial team to ensure adherence to the conference scope and abstracts which have passed this initial screening are then assigned to the session chair / review committee for evaluation.
  • Once the reviews have been received, the review committee decides to accept or reject a manuscript, or to request revisions from the author in response to the reviewers’ comments. If the decision tends to be minor revision or major revision, authors will be given 14 days to resubmit the revised abstract.

Criteria to be considered for Scoring:
The abstract should be reviewed according to the following criteria:

  • Originality of concept/approach and level of innovativeness
  • Significance/impact/relevance to conference theme
  • Quality of research design/theoretical argument
  • Conclusions and interpretations of results
  • Presentation style: coherence and clarity of structure

Join your peers around the world focused on learning about Biologics and Biosimilars related advances, which is your single best opportunity to reach the largest assemblage of participants from the Biosimilars community, conduct demonstrations, distribute information, meet with current and potential professionals, make a splash with a new research works and receive name recognition at this 2-day event. World-renowned speakers, the most recent research, advances, and the newest updates in Biologics and Biosimilars are hallmarks of this conference. 

Presenting Your Organization’s Work on a Global Stage:

As a speaker you will be presenting to a room full of senior representatives from all over the world, each providing a different perspective from the sector. Your organization’s expertise and knowledge will be showcased to key players in the field of Pharma, Medical and Health care will be a unique platform to increase your reputation within the sector

New Places and New People:

Each time will be held at a different place, new and different people will attend. This can enlarge building collaborations and help you in developing new relationships.

Learn from other speakers:

As a speaker you will be provided with free access to three days of the conference and associated workshops and will be given the opportunity to hear from other senior representatives from the sector and consider problems and solutions in the field of Biosimilars and Biologics, our numerous Q&A sessions and panel discussions.

Discuss and Overcome Issues In The Field:

This conference offers unrivalled opportunities to work with other key leading experts from the Pharma industry, Universities and Hospitals to discuss the main challenges in the sector and to come together to produce strategies to find solutions to these problems Competitive Advantage: You’ll stand out if you’re a sponsor and your major competitors aren’t. If your competitors have already decided to be sponsors, your sponsorship becomes even more important, to assert your comparative market strength and your commitment to healthy products.

Leading a Workshop:

By leading one of the renowned Workshops, you will be presented with a perfect forum for an in depth discussion and debate into a key issue. These sessions can vary in format from case-study-led debate with interactive breakout sessions to a presentation based discussion group on a topic that may need a particular in-depth focus.

The Opportunity to Collaborate and Sponsor:

While we determine our conference theme and flow, we invite our key sponsors to suggest potential speakers, Delegate and topics that might also enhance the program. That’s why it’s important to commit early to sponsorship, before the program is final.

Chairing:

To increase your presence at the event, why not chair the event, a day, or a specific session to present yourself and your organization as one the leading players in a specific topic area? As a chair, you will work closely with us and our line-up of senior level speakers to ensure an event’s success

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Organizing Committee

Roman Drai

Roman Drai

Director, GEROPHARM

Biography

Prof. Aliasgar Shahiwala

Prof. Aliasgar Shahiwala

Program Director, UAE

Biography

Michael MUENZBERG

Michael MUENZBERG

Biosimilars Consulting CH, Switzerland

Biography

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Know Your Registration

SPEAKER REGISTRATION
$549

  • Access to all Conference Sessions
  • Opportunity to give a Keynote/ Plenary/ Poster Presentations/ Workshop
  • Opportunity to publish your Abstract in any of our esteemed Journals & in the Conference Proceedings Book
  • Certificate Accredited by our Organizing Committee Member
  • Handbook & Conference Kit

DELEGATE REGISTRATION
$449

  • Access to all Conference Sessions
  • Can meet the Experts of your Area of expertise arriving from 22+ different Countries
  • Participation Certificate Accredited by our Organizing Committee Member
  • Delegates are not allowed to present their papers in Oral or Poster sessions
  • Handbook & Conference Kit

STUDENT REGISTRATION
$349

  • Access to all Conference Sessions
  • Opportunity to give an Oral/ Poster Presentation
  • Opportunity to publish your Abstract in any of our esteemed Journals & in the Conference Proceedings Book
  • Certificate Accredited by our Organizing Committee Member
  • Handbook & Conference Kit

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