- The creation of the MDRP in 1990
- How the environment and markets have changed
- Why a new paradigm is needed – growing misalignment of incentives
- Potential solutions
Francis J. Rienzo, Vice President, Government Relations and Advocacy, Medicaid Health Plans of America
- Reasons why US biosimilars entry has been so slow
- Understanding the nuances of the BPCIA and FDA guidelines
- Structured path to biosimilars approval
- Key elements to reduce time and cost-- first-hand experience analysis
Sarfaraz K. Niazi, PhD, SI, FPAMS, FACB, FRSB, Founding Executive Chairman, Karyo Biologics, LLC
- How may the biosimilar market in the US evolve? Who will be the winners and losers in each case?
- How can small/mid-sized players compete and succeed in US biosimilars – Views on 3 key dimensions: Investments, Portfolio and Commercialization
Anshuman Patwardhan, PhD, MBA, Vice President, Global Licensing & BD - Biologics, Lupin Pharmaceuticals
- Review of the impediments to biosimilar development and commercialization, include regulatory barriers, reimbursement barriers, commercial strategies, and legal barriers that interfere with the approval and launch of biosimilars.
- Potential legal and Policy Solutions
Bruce Leicher, Sr. Vice President and General Counsel, Momenta Pharmaceuticals, Inc.
- How can the US Patient Protection and Affordable Care Act (ACA) solve long-standing challenges the US health care system is facing related to access, affordability, and quality of care?
- What impression does recent changes in regulation, science & production technologies on future patterns of production?
- Issues to overcome to increase uptake of biosimilars
- Can the increased use of biosimilars in the US health care system could enable stakeholders to better achieve expanded access, reduce costs, and improve the quality of care?
Bruce Leicher, Sr. Vice President and General Counsel, Momenta Pharmaceuticals, Inc.
Francis J. Rienzo, Vice President, Government Relations and Advocacy, Medicaid Health Plans of America
Jim Cucinotta, RRT, MPH Sr. Director, Global Clinical Operations, Teva Pharmaceuticals
- The challenges for sponsors of Biosimilar Products (BP) due to the existing divergent regulatory expectations for licensure in different regions (Asia, EU, US, etc.) will be discussed.
- The outcome from discussions with leading US and EU agency representatives and BMPWP representatives at the recent 2017 PDA/FDA Biosimilars conference in Washington DC will be used to illustrate points of divergence in regulatory expectations.
- This presentation will highlight the existing differences in USFDA expectations for analytical similarity conditions versus other regulatory regions.
- Focus will be on some of the current USFDA (draft) guidance document(s) shortcomings which could make it more difficult to obtain approval in the US.
- Some brief case studies and examples will be provided.
Stephan O. Krause, PhD, Director of QA Technical Support, AstraZeneca Biologics, USA
- Considerations for quality attributes selection for comparability study and similarity assessment
- Drug substance versus drug product testing in biosimilarity assessment
- Development of biosimilar products as combination products
- CMC challenges in developing biosimilar products
Dr. Seraphin Kuate, PhD, MBA, RAC, Assoc. Director, Global CMC, Biologics, Boehringer Ingelheim
- 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
- Reducing capital investment and creating cost-effective and scalable manufacturing operations
- Brief history of evolution of naming requirements including impact of INN process on FDA
- FDA guidance on suffixes
- FDA guidance on how to use product names (reference and biosimilar) in labeling
- Unresolved issues
Michael A. Swit, Esq., Legal Counsel, Law Offi ces of Michael A. Swit
- Key considerations for approval
- Post-marketing change management
Partha Roy, Vice President, Technical, PAREXEL Consulting
- Latest trends in regulatory requirements
- Nuances in biosimilar development for markets outside of EU and USA
- Shifting focus from biosimilars of ‘blockbusters” to ‘niche” drugs
- Moving from biosimilars to bio-betters
Oxana Iliach, PhD, Sr. Director Global Regulatory Strategy and CMC, Biosimilars Center of Excellence, IQVIA
- Identify challenges of unmet medical needs posed by current biologics and biosimilars
- How to differentiate biobetters from biosimilars?
- Challenges and opportunities in developing biobetters vs. biosimilars
- Why demonstrating superiority is challenging?
- Regulatory and cost considerations in developing biobetters vs. biosimilars
Rakesh Dixit, Ph.D., DABT, Vice President, Research & Development, Medimmune
- 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
Moderator: Michael A. Swit, Esq., Legal Counsel, Law Offices of Michael Swit
Ajay Ahuja, MD, Formerly Vice President, Medical Affairs, Hospira Inc and Pfizer Inc
- Insight on detailed guidance for coding
- Will this encourage more companies to develop biosimilars?
- Is this a case of encouraging more competition in biosimilars space to lower price and reduce spending?
- Can the new policy help to ensure robustness of the US biosimilars market?
- 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
- Impact of pharma pricing on pharmaceutical innovations
- Biosimilars influence on pricing and reimbursement
- How to ensure market access success
- Patient centric approach in driving market access growth
- Is there an alternative payment model?