Biosimilars Review & Report (BR&R) is an independent resource covering FDA-approved biosimilars, biosimilar clinical development, regulatory policy, market access, pricing, reimbursement, and the evolving US biosimilar marketplace. At BR&R, we routinely report on and comment on biosimilar news, clinical trials, regulatory policy, legislative developments, drug approvals, market access, and reimbursement, including developments related to the 351(k) regulatory pathway.
The regulatory policy, marketing issues, and clinical testing of biosimilar medicines has evolved greatly since 2012. Biosimilar medicines have introduced scientific, regulatory, clinical, and commercial considerations that differ from those involved in traditional brand-to-generic competition. These differences can complicate policy, coverage, reimbursement, and market access decisions.
As a result, BR&R provides resources, education, commentary, and updates on the biosimilar marketplace, in the form of a frequently updated database of biosimilar drugs. BR&R covers:
- Biosimilar approval status: Updated information on the status of all biosimilars approved in the US as well as investigational biosimilar candidates with publicly disclosed information
- Biosimilar drug research and biosimilar clinical trial news
- Biosimilar news and articles with commentary on biosimilar drug approvals, 351(k) pathway and regulatory issues, contracting/rebating, biosimilar market access, biosimilar pricing and reimbursement
- Meeting highlights from national professional conferences with biosimilar-related content
- Progress tracking of newly launched biosimilar products
Biosimilar Review & Report was founded in 2013 by Stanton Mehr, a veteran health care industry consultant, observer, editor, and writer. Stan has decades of publishing experience. He has published a multitude of articles on pharmaceuticals, managed care, and health policy. He was also the founding writer for the Center for Biosimilars in 2016. Stan is considered a pioneer in reporting on the biosimilar industry.
For more information, or to reach Stan about the biosimilar industry, please see our Contact page.
