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
- Regulatory issues
- Scheduled biosimilar-related conferences
- Scheduled FDA Advisory Boards
- Progress tracking of new market entrants
The principal behind Biosimilar Review & Report, Stanton Mehr, is a veteran consultant, observer, and writer in the health care industry. Stan has decades of experience publishing on the pharmaceutical, managed care, and health policy areas. Since 2013, he has been reporting and consulting on the biosimilar industry.
At BR&R, we routinely observe, report, and comment on news, clinical trials, and policy issues related to the 351(k) regulatory pathway and process of drug approval, market access, and reimbursement of these agents.
For more information or to reach Stan about the biosimilar industry, please see our Contact page.