Agenda

20th - 22nd March 2017

  • Regulators decisions regarding biosimilar interchangeability and indications.
  • How to demonstrate biosimilarity to the reference product
  • How similarity informs interchangeability and extrapolation
  • Current requirements in clinical considerations: switching and immunogenicity

RODEINA CHALLAND, CONSULTANT, CHALLAND BIOSIMILAR CONSULTING

  • National and International developments in biosimilar medicines
  • Challenges of Physicians education: Understanding the differences between biosimilars and generics
  • Importance of Physician and Patients input in shaping international standards for biosimilars
  • Policies in place to encourage physicians / pharmacist collaboration
  • Harmonizing global standards to ensure safety and efficacy of biosimilars

RESERVED FOR SENIOR REPRESENTATIVES FROM SAFEBIOLOGICS

  • Challenges and opportunities in global Biosimilars market
  • Current trends in global industry of Biosimilars
  • Priorities of investments and opportunity for market growth

RODEINA CHALLAND, CONSULTANT, CHALLAND BIOSIMILAR CONSULTING

  • Evidence required for the regulatory approval of biosimilars and follow-on biologics
  • How to overcome hurdles such as patent dispute resolution process under BPCIA
  • Post approval factor that may hinder uptake of biosimilars

  • Regulatory Aspects and Quality Strategy
  • Reference Product
  • Layout of analytical Program for Biosimilars
  • Case Studies

ULRIKE KONRAD, MBA, BUSINESS DEVELOPMENT MANAGER, PROTAGEN PROTEIN SERVICES

  • How much data and evidence is required to support the switching of mAb biosimilars
  • Clinical studies and real world data for efficacy and safety
  • Case study

STANLEY SEUNGSUH HONG, Ph.D, SENIOR ADVISER, CELLTRION

  • Critical first step involves extensive interrogation of multiple originator batches to define the target
  • Subsequent side-by-side comparison of the biosimilar with the originator to determine biosimilarity
  • Strategies for protein primary and higher order structure determination including measurement of post-translational modifications such as glycosylation and other Critical Quality Attributes
  • Orthogonal analytical techniques for “fingerprint-like” assessment

  • Feasibility studies
  • Process and analytical development
  • Scale-up techniques
  • How to optimize protein therapeutics reducing time to market

  • Critical quality attributes and higher order structural elements
  • Risk-based approaches to biosimilar development
  • Strategies in maintaining high quality standard
  • Recent development shaping the guidelines for advancing product development and its implications

  • What are the technologies that enables continuous manufacturing
  • Requirements for designing a robust continuous process
  • Strategies to minimize intermediate sample conditioning to ensure a continuous flow

BRENDA GOMEZ VALENTE, EXPERT, REGULATION AND HEALTH SURVEILANCE, ANVISA

  • EMA was the first regulatory authority to develop a pathway for biosimilars
  • Bioisimilars have been on the market in Europe for 10 years in endocrinology, nephrology and oncology (first wave)
  • Europe have also had Mab biosimilars in autoimmune for the past 3 years
  • This presentation will review the various barriers faced by biosimilar companies in Europe highlighting from a medical affairs perspective the solutions that paved the way to success

MATTHEW TURNER, GLOBAL MEDICAL DIRECTOR, MERCK

  • US legal framework for biosimilar and interchangeable biosimilar
  • FDA guidance on interchangeable biosimilar
  • Challenges during development of interchangeable biosimilar
  • Acceptance of biosimilar and interchangeable biosimilar as alternative treatment

CINDY CAO, HEAD, REGULATORY AFFAIRS BIOPHARMACEUTICAL, SANDOZ INC., A NOVARTIS COMPANY

  • Discussion of the guidance document
  • Implication for promotion and advertising
  • Challenges for compliance

BRUCE LEICHER, SVP & GENERAL COUNSEL, MOMENTA PHARMACEUTICALS

  • Will biosimilars open the door to provide access to affordable medicines
  • What impression does recent changes in regulation, science & production technologies on future patterns of production
  • Issues to overcome to increase uptake of biosimilars

  • Overview of current regulatory guidelines
  • Next era of Biosimilars program under the second Biosimilar User Fee Act (BsUFA II)
  • Key advantage of using abbreviated pathway for biosimilars developer
  • Robust analytical data to demonstrate similarities

TED CARVER, PRINCIPAL CONSULTANT, PAREXEL INTERNATIONAL

  • The Brazilian Biosimilars Market;
  • Manufacturing Biosimilars in Brazil;
  • Strategic partnerships

ANDREW SIMPSON, SCIENTIFIC DIRECTOR, ORYGEN BIOTECHNOLOGICA

  • Updates on the latest global regulatory guidelines
  • Current challenges to make sure the development pathways are ready for the latest scientific development
  • The current status of biosimilars products in the US, Europe and rest of the World
  • Looking into the science of extrapolation
  • Novel methods and study design to demonstrate biosimilarity

  • Considerations in early clinical development
  • Factors to be included in designing a clinical trial development for Biosimilars
  • Challenges in clinical operations
  • Best operational procedure to minimise cost and maximise result

MOLLY BURICH, ASSOCIATE DIRECTOR OF PUBLIC POLICY, BIOSIMILARS, BOEHRINGER-INGELHEIM

  • Regulatory Framework and expectations
  • Nature and extent of clinical studies
  • State-of-the-art technologies to demonstrate a high degree of structural and functional similarity
  • Clinical pharmacokinetic and pharmacodynamics studies and data

  • Risk-based approaches to biosimilar development
  • Strategies in maintaining high quality standard
  • Recent development shaping the guidelines for advancing product development and its implications

MING WANG, PRESIDENT, CEO, PHANES THERAPEUTIC

  • Evaluating the safety and effectiveness of switching
  • Clinical studies and real-world experience
  • Can all patients be switched?
  • How can policymakers take care in how they interpret – and apply – data on switching?

DR. STEINAR MADSEN, MEDICAL DIRECTOR, NORWEGIAN MEDICINES AGENCY

  • Special trends impacting market access in the US and globally
  • Evolving methods for managing specialty product utilization and reimbursement toward ensuring appropriate access
  • Ways of balancing rewards of access and inherent risk between manufacturers and insurers
  • Challenges in ensuring market access and reimbursement

  • Challenges and opportunities in global Biosimilars market
  • Current trends in global industry of Biosimilars
  • Priorities of investments and opportunity for market growth