Robert Cerwinski: The Impact of TC Heartland on Biosimilar Litigation
Robert Cerwinski, JD, Partner at Goodwin, discusses the impact of the recent Supreme Court ruling in TC Heartland v Kraft on biosimilar litigation.
Dr Brandon Shank: Biosimilar Naming and Suffixes
Brandon Shank, PharmD, MPH, BCOP, Clinical Pharamcy Specialist, discusses the merits of the current biosimilar naming system.
Dr Kashyap Patel: Biosimilars and Medicare Part D Drug Pricing
Kashyap Patel, MD, Medical Oncologist, Carolina Blood and Cancer Care, discusses the potential impact of biosimilar drugs on Medicare Part D drug pricing.
Dr Marcus Snow: Automatic Substitution of Biosimilars in Rheumatology
Marcus H. Snow, MD, Assistant Professor Rheumatology, University of Nebraska, discusses concerns about automatic substitution of biosimilars for reference products.
Robert Cerwinski: Current Infliximab Litigation
Robert Cerwinski, JD, Partner at Goodwin, discusses current infliximab litigation.
Dr Bruce A. Feinberg: Biosimilar Labeling and Extrapolation
Bruce A. Feinberg, DO, CMO, Cardinal Health Specialty Solutions, discusses biosimilar labeling and concerns with extrapolation.
Robert Cerwinski: The Potential for an Executive Order on Drug Pricing
Robert Cerwinski, JD, Partner at Goodwin, discusses the potential for an upcoming executive order on drug pricing.
Robert Cerwinski: Recent Trends in PTAB Decisions on Biologics, Biosimilars
Robert Cerwinski, JD, Partner at Goodwin, discusses the “big 3” biologics for inter partes review: Herceptin, Rituxan, and Humira.
Ha Kung Wong: Current BPCIA Litigation in Biosimilars
Ha Kung Wong, JD, Partner at Fitzpatrick, Cella, Harper and Scinto, discusses current BPCIA litigation concerning biosimilar products.
Biosimilars in the Next 5 Years
State Legislation on Biosimilars and Substitution
Naming and Coding of Biosimilars
Cost, Patient Programs, and Access to Biosimilars
Competition and Cost for Biosimilars
Cost and Biosimilars in Oncology
Extrapolation of Indications in Biosimilars
Payer Intervention and Biosimilar Switching
Patient Awareness of Biosimilar Products
Post-Market Pharmacovigilance
Clinical Trial Design With Biosimilars
Physician Understanding of Biologic Manufacturing
Chronic Therapy and Switching
Prescribing Behaviors and Biosimilar Substitution
Biosimilar Prescribing and Cost in Rheumatology
Cost and Biosimilar Uptake for Oncology
Delivery Systems and the Acceptance of Biosimilars
Adoption of Biosimilars in the United States and Europe
Dr Marcus H. Snow: The US Launch of Renflexis
Marcus H. Snow, MD, Assistant Professor Rheumatology, University of Nebraska, discusses the recent launch of a new biosimilar infliximab, Renflexis, in the United States.
Robert Cerwinski: Healthcare Reform and the BPCIA
Robert Cerwinski, JD, Partner at Goodwin, discusses what becomes of the BPCIA if the Affordable Care Act is repealed by Congress.
Ha Kung Wong: The FDA's Role in Clarifying the BPCIA
Ha Kung Wong, JD, Partner at Fitzpatrick, Cella, Harper and Scinto, discusses whether the FDA might clarify its stance on the BPCIA.
