Biosimilars Review & Report

The regulatory, marketing, and clinical testing of agents that are biosimilar to “innovator” or “reference” products has been extremely unsettled. The very nature of these biologic products complicates policy and coverage decision making in a way that is far more challenging than the brand–generic decisions of the past 40 years. As a result, Biosimilars Review & Report (BR&R) exists to provide education, commentary, and updates on the biosimilar marketplace, in the form of a frequently updated resource on the entire field, including:

• Biosimilar drug research and clinical trial development
• Approvals
• Regulatory issues
• Contracting/rebating/pricing
• Scheduled biosimilar-related conferences
• Scheduled FDA Advisory Boards
• Progress tracking of new market entrants