Building on the success of previous events, SMi proudly announces the return of its 4th annual Biosimilars North America Conference, taking place on November 15 and 16, 2017 in Iselin, New Jersey.

The first biosimilar product launched in the US in 2015. Currently there are only 4 biosimilar products approved but the North Americas market continues to grow and has become highly lucrative. As such, pharmaceutical companies continue to find ways to differentiate their products in such a saturated market. Thus, Biosimilars North America 2017 will provide an intelligent meeting to explore novel and innovative strategies to advance biosimilar development, and ensure optimal market access and commercialization opportunities whilst complying with evolving regulatory requirements.

This year, the conference will also explore significant developmental topics within the sector including the impact of FDA’s newly implemented biosimilar interchangeability guidelines, the US market access landscape, and biosimilars of orphan drugs.


  • Hear Sandoz talk on the FDA issuing the long awaited biosimilar interchangeability guidance
  • Explore complex Biosimilars and new technologies from MedImmune
  • Learn how to combat the legal, policy and commercial obstacles to the development and launch of Biosimilars with Momenta Pharmaceuticals
  • Gain insights from FUJIFIlM Diosynth Biotechnologies on Biosimilar latest development strategies and successfully bringing biosimilars to market
  • Examine the drug product and formulation developmentconsiderations for biosimilars with Oncobiologics Inc

Abzena; AmerisourceBergen; Amgen; Antares Pharma; Ares-Trading (Merck); Bionovis; Boehringer Ingelheim; Challand Biosimilar Consulting; EGeen International Corporation; Eli Lilly and Company; FFF Enterprise; Gan & Lee Pharmaceuticals USA Co.; GPhA (Generic Pharmaceutcal Association); Kim & Chang; Lupin Pharmaceuticals; Lupin Pharmaceuticals Inc; Lupin Pharmaceuticals, Inc.; Medimmune Inc; Merck; Merck AND Co Ltd; Myoderm; Norwegian Medicines Agency; Oncobiologics; Orygen Biotecnologia Ltda; Pfizer; Pfizer Global Pharmaceuticals; Pfizer Inc; Pfizer Inc.; Pfizer, Inc; Prescient Healthcare Group; SAI MedPartners; Samsung BioLogics; Sandoz; Sandoz Inc; Sandoz Inc.; Sandoz Pharmaceuticals; Schwegman Lundberg Woessner; Teva Pharmaceuticals; Teva Pharmaceuticals USA; UBC - An Express Scripts Company; Vizient Inc.; Wyatt Health Management; ZS Associates;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Richard Dicicco

Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals USA, Inc.

9:10 Biosimilars 12 years on: Where are we and what’s next?

Patrick Lucy

Patrick Lucy, Chief Business Officer, Pfenex Inc

  • Where are we heading?: Market overview
  • Key milestone and hurdles overcome
  • What to keep in mind doing forward?
  • 9:50 FDA issues long awaited biosimilar interchangeability guidance

    Cindy Cao

    Cindy Cao, Executive Director & Head of US Regulatory Affairs for Biopharmaceuticals, Sandoz Inc

  • The impact of the new guidelines
  • Interchangeability: Considerations for a single switch vs. multiple switches
  • Engaging with your stakeholders - how will switching work?
  • 10:30 Morning Coffee

    11:00 From biosimilar approval to biogenerics in clinical practice

    Steinar Madsen

    Steinar Madsen, Medical Director, Norwegian Medicines Agency
    View Bio

  • Attitudes and acceptance
  • Uptake in clinical practice – the European experience
  • Nor-Switch study and other clinical trials
  • Switching is already there – do we need interchangeability?
  • 11:40 Legal, Policy and Commercial Obstacles to the development and launch of Biosimilars

    Bruce Leicher

    Bruce Leicher, Sr. Vice President and General Counsel, Momenta Pharmaceuticals

  • The use of Public Policy and Guidance to Promote Evergreening of Reference Products
  • Restricted access to reference products and REMS Abuse
  • 12:20 Networking Lunch

    13:20 How to ensure optimal market access for biosimilars

    Gary C Cupit

    Gary C Cupit, President & CEO, Sapphire Therapeutics

  • The economics of biosimilars
  • How should we price biosimilars?
  • What can be done by payers to ensure long term savings?
  • 14:00 Building a biologics empire: Being both the originator and biosimilar Innovator

    Mkaya Mwamburi

    Mkaya Mwamburi, Vice President, HEOR/Evidence Generation, profecyINTEL, LLC

  • It’s not a conflicting scene - complimenting your portfolio with both original biologics and biosimilars
  • The story behind - from technical capabilities to branding
  • What’s the best approach and how to hedge?
  • 14:40 Afternoon Tea

    15:10 Biosimilars of orphan drugs: The case study of biosimilar Eculizumab

    Richard Dicicco

    Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals USA, Inc.

  • Eculizumab global market data
  • Cost and development risk requires a change in extrapolation strategy
  • Defining the target quality profile and critical quality attributes
  • The right patient assistance program is necessary for biosimilar orphans
  • 15:50 Drug product and formulation development considerations for biosimilars

    Hiten Gutka

    Hiten Gutka, Principal Scientist Formulation Development Biosimilar Development, Oncobiologics

  • Considerations in development of formulation and Drug Product for Biosimilars
  • Excipient quality and influence on biosimilar drug product quality and stability, Container closure effect on stability of biosimilar drug product
  • Similarity assessment and the role of formulation and drug product.
  • 16:30 The Road to biosimilars: Reaching our destination with the patient in mind

    Chrys Kokino

    Chrys Kokino, Global Commercial Head, Mylan Inc

  • Road Today: Lessons learned from EU and RoW as we look towards US launches
  • Detours: New guidelines, naming, reimbursement, interchangeability
  • Road Ahead: Keeping the patient and other stakeholders in mind
  • 17:10 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Richard Dicicco

    Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals USA, Inc.

    9:10 Bioinnovations: Optimized cell signaling technology (CST) and speed to market

    Sarfaraz Niazi

    Sarfaraz Niazi, Founding Executive Chairman, Adello Biologics LLC

  • Ground-up re-arrangement of customary steps—continuing manufacturing using single containers
  • ISO9 environment
  • Scale up-free and Comparability Protocol-free deployment
  • 9:50 Understanding the U.S. market access landscape for biosimilars

    John Carlsen

    John Carlsen, Vice President, Covance Inc

  • Review key CMS policy developments for biosimilars (e.g., Medicare guidance, coding decisions, payment policies) and understand the potential impact on commercial payers' policies
  • Highlight coding and Medicare payment for currently available biosimilar products, understand the link between coding/payment and pricing, and discuss what this means for biosimilars approved in the future
  • Gain insight into how commercial payers are covering and managing biosimilars, as well as the resulting impact on patient access to competing innovator products (based on original research conducted by Covance)
  • Assess the implications for reimbursement hubs, patient assistance programs, and other customer support resources


  • 10:30 Morning Coffee

    11:00 Advancing complex Biosimilars and new technologies

    T. Shantha Raju

    T. Shantha Raju, Senior Director of Analytical Sciences, Medimmune Inc

  • Challenges of complex biologics molecules: are they similar or ‘highly similar’ to the originators?
  • High throughput screening - from molecular to structural characterization
  • New platforms for fi ngerprinting - discovering the ‘DNAs’ of your biologic molecule early on
  • 11:40 Dyadic’s C1 Expression System, a potential CHO Stopper

    Mark Emalfarb

    Mark Emalfarb, Founder, Chairman and CEO, Dyadic International Inc.

  • Dyadic’s C1 platform technology: Helping to bring biologic drugs through development to market faster in greater volumes due to its superior yielding properties
  • Dyadic’s C1 platform technology: Reducing the cost of R&D and commercial manufacturing in healthcare through both lower CapEx and OpEx
  • Multiple addressable markets: C1 can address innovator biopharma markets for new drugs as well as being the platform of choice for BioSimilars/BioBetters.
  • 12:20 Networking Lunch

    13:20 Biosimilar latest development strategies in successfully bringing biosimilars to market

    Patrick Robertson

    Patrick Robertson, Director, Program Design, Fujifilm Diosynth Biotechnologies

  • Challenges and obstacles faced by manufacturers in developing biosimilars
  • How to overcome challenges, increase development success and optimize result
  • Techniques in bringing the next generation of Biosimilars to the market
  • 14:00 Global business development overview

    Leandro Mieravilla

    Leandro Mieravilla, Global Market Access mAbs, Cassara Biotech

  • Differences among different continents to introduce biosimilars
  • Main Players
  • Main biosimilar products at main markets
  • Global strategies implemented by companies
  • 14:40 Afternoon Tea

    15:10 Amgen v. Sandoz: the U.S. Supreme Court’s First Foray into the BPCIA

    Carlos Angulo

    Carlos Angulo, Partner, Zuckerman Spaeder LLP

  • Is the BPCCIA’s patent dance mandatory or optional?
  • Does the “notice of commercial marketing” provision give brand companies 6 additional months of exclusivity
  • The potential impacts of the Court’s decision
  • 15:50 Opportunities for biosimilar and biobetter drugs in Brazil

    Don  Stewart

    Don Stewart , CEO, PlantForm Corp

  • Establishing Partnerships
  • Funding Scenarios
  • Technology Transfer and Manufacturing


  • 16:30 Chairman’s Closing Remarks and Close of Day Two


    Official Media Partner

    Official Publication



    Renaissance Woodbridge Hotel

    515 US Highway 1 South, Iselin, New Jersey, USA

    Your simple delights will become memorable moments at Renaissance Woodbridge Hotel. This distinctive hotel in Edison, New Jersey, features 269 modern guest rooms, including 42 suites, and more than 25,000 square feet of flexible meeting space. Our hotel's location is centrally located amidst corporate offices and tourist attraction. Our accommodations stand out from other hotels in Edison, NJ, and provide a sophisticated retreat for families and business travelers alike. Marriott's Plug-in panels and 37-inch LCD HD TVs allow guests simultaneous connectivity to laptops, iPods and DVD players. We are one of the most conveniently situated hotels at the crossroads of U.S. Routes 1 and 9. We are also just five minutes from Woodbridge Center Mall, 15 minutes south of Newark Liberty International Airport (EWR) and less than one mile from the Metropark train station. With our premier location and amenities, our Edison accommodations provide an advantageous travel destination.


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    Biosimilar Development

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    Biosimilar Development is dedicated to presenting technical information, thought leadership, and commentary for the biosimilar development and manufacturing community. On this site, users will find exclusive and actionable content on the industry trends and challenges affecting the emerging biosimilars market. Browse our articles, case studies, and white papers on topics related to biosimilar development, manufacturing, quality, distribution, FDA guidance, BPCIA, global markets, government regulations, and intellectual property. Biosimilar Development is part of the Life Science Connect media group, which strives to facilitate connections and foster collaborations in pharmaceutical development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.


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    Generics and Biosimilars Initiative (GaBI) was founded in 2008. GaBI aims to foster the worldwide efficient use of high quality and safe medicines at an affordable price, thus advancing and supporting the idea of accessible, affordable and sustainable health care. The objective of GaBI is to raise the scientific status of generic and biosimilar medicines, via well-documented and up-to-date information about generic and biosimilar medicines both in print (www.gabi-journal.net) and electronically (www.gabionline.net) in an open access format, providing high quality, scientifically sound and reliable information to healthcare professionals including physicians, pharmacists and nurses, consumers, drug developers, third-party payers, legislators and assessors; who are in need of a reliable, critical and independent source of information on all aspects of generic and biosimilar medicines. Subscribe to gain easy access of information on the latest scientific research and developments in generic and biosimilar medicines via GaBI Online to editorial@gabionline.net; or submit a manuscript to GaBI Journal to editorial@gabi-journal.net. GaBI’s mission – Building trust in cost-effective treatments

    American Pharmaceutical Review

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    Start receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy

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    Renaissance Woodbridge Hotel

    515 US Highway 1 South
    Iselin 08830

    Renaissance Woodbridge Hotel

    Your simple delights will become memorable moments at Renaissance Woodbridge Hotel. This distinctive hotel in Edison, New Jersey, features 269 modern guest rooms, including 42 suites, and more than 25,000 square feet of flexible meeting space. Our hotel's location is centrally located amidst corporate offices and tourist attraction. Our accommodations stand out from other hotels in Edison, NJ, and provide a sophisticated retreat for families and business travelers alike. Marriott's Plug-in panels and 37-inch LCD HD TVs allow guests simultaneous connectivity to laptops, iPods and DVD players. We are one of the most conveniently situated hotels at the crossroads of U.S. Routes 1 and 9. We are also just five minutes from Woodbridge Center Mall, 15 minutes south of Newark Liberty International Airport (EWR) and less than one mile from the Metropark train station. With our premier location and amenities, our Edison accommodations provide an advantageous travel destination.



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    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.


    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.


    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.


    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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