Biosimilar Interchangeability and Market Share
Dr Angus Worthing: Congressional Budget Allocation for Healthcare
Angus Worthing, MD, FACR, FACP, discusses the need for adequate funding for the FDA and healthcare.
Robert Cerwinski: Hatch-Waxman Litigation of Follow-On Insulins
Robert Cerwinski, JD, partner at Goodwin, explains why Hatch-Waxman litigation may provide a smoother path than does the Biologics Price Competition and Innovation Act.
Robert Cerwinski: Oil States and the Inter Partes Review Process
Robert Cerwinski, JD, partner at Goodwin, discusses a petition before the Supreme Court challenging the constitutionality of inter partes review.
Dr Brandon Shank: Pharmacy School Curriculum and Biosimilars
Brandon Shank, PharmD, MPH, BCOP, Clinical Pharmacy Specialist, discusses the need for pharmacy schools to adapt their curriculum to address biosimilar treatments.
Robert Cerwinski: Pay-for-Delay Settlements and Agency Scrutiny
Robert Cerwinski, JD, partner at Goodwin, discusses the potential for government agencies to weigh in on pay-for-delay settlements in the biosimilars space.
Dr Brandon Shank: Reimbursement Challenges With Biosimilars
Brandon Shank, PharmD, MPH, BCOP, Clinical Pharmacy Specialist, discusses the potential for reimbursement challenges with biosimilars.
Dr Bruce A. Feinberg: Patient Education on Biosimilars
Bruce A. Feinberg, DO, CMO, Cardinal Health Specialty Solutions, discusses the importance of patient education on biosimilar treatments.
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