- 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
- 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?
- 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 enable stakeholders to better achieve expanded access, reduce costs, and improve the quality of care?
Panelist: Bruce Leicher, Sr. Vice President and General Counsel, Momenta Pharmaceuticals, Inc.
Panelist: Francis J. Rienzo, Vice President, Government Relations and Advocacy, Medicaid Health Plans of America
- 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
- Participation in the Patent Dance?
- Recent Case Law Update
Thomas Haag Ph.D. Partner, Intellectual Property Department, Seyfarth Shaw LLP
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
- 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
- The development of anti-drug antibodies (ADAs) is a common cause of biologic drug hypersensitivity reactions and treatment failure
- Biosimilars are limited by the safety and efficacy profile of the innovator drug and face a highly competitive market
- Biobetters are potentially de-risked products if they can be differentiated from competitive drugs
- We have developed tolerogenic nanoparticles to mitigate the formation of ADAs
- I will present preclinical and clinical data from case studies with a pegylated uricase for the treatment of severe gout, currently in Phase 2 clinical testing and a recombinant immunotoxin for the treatment of mesothelioma, currently in Phase 1 clinical testing
Dr. Kei Kishimoto, Chief Scientific Officer, Selecta Biosciences
- 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
Ajay Ahuja, MD, Formerly Vice President, Medical Affairs, Hospira Inc and Pfizer Inc
- In-depth assessment of the current trend in global biosimilar market
- Significant hurdles to further growth of the biosimilar market
- Strategies adopted by leading pharmaceutical companies to compete in the biosimilar market
Richard Di Cicco, Co-founder, Harvest Moon Pharmaceuticals
- 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 A. Swit
Panelist: Oxana Iliach, PhD, Sr. Director Global Regulatory Strategy and CMC, Biosimilars Center of Excellence, IQVIA