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Biosimilar Education Evolution: Who Educates and Who Updates It?
Despite biosimilars’ long availability, education remains inadequate and must reflect evolving FDA requirements, evidence, and expanded use. Stakeholders view education as a shared responsibility involving regulators, academia, manufacturers, and continuing education providers. However, limited curricula, resources, physician confidence, and patient communication challenges persist, leaving the FDA as the primary trusted educational source.
BsUFA IV: Fee Changes and Program Maturity
The fourth Biosimilar User Fee Agreement (BsUFA IV) negotiations were only recently concluded, and the result poses new opportunities for biosimilar manufacturers. At last week’s GRx+Biosims meeting, several sessions touched on the significant changes to the program.
Fresenius Kabi Expands Biosimilar Pipeline With Deal for Next-Generation Molecules
Joining forces with a Chinese biologics company enabled Fresenius Kabi to obtain rights up for up to 37 biosimilar candidates over the next decade. Fresenius Kabi, a serious player in the US biosimilar arena, had been seeking ways to bolster its biosimilar pipeline, and it made quite a splash earlier this week. The company signed … Continue reading Fresenius Kabi Expands Biosimilar Pipeline With Deal for Next-Generation Molecules
Preparations Being Made for Much-Delayed Introduction of Enbrel Biosimilars
Samsung Bioepis’ deepening ties with Teva has yielded a new deal for its etanercept biosimilar Eticovo. Under the new agreement, Teva will obtain US commercialization rights to etanercept-ykro. The timing of Eticovo’s commercial launch in the US will be determined by Teva, accordin to the press release.
The Evolution of the Biosimilars Market
Since 2013, Biosimilars Review & Report (BR&R) has tracked FDA biosimilar approvals, pipeline developments, clinical trials, biosimilar policy decisions, and market access trends in the United States.
“Evolution” of the biosimilar marketplace is the key word. Since the implementation of the Biologics Price, Innovation, and Competition Act in 2010, the regulatory policies of the US Food and Drug Administration, the relationship of the commercial and public insurers with biosimilars and their innovator or reference products, and the future of biosimilar development has been in flux. This includes:
- The clinical trial requirements for biosimilar candidates
- Biosimilar naming conventions
- Exclusivity periods
- The nature of interchangeability (or even the necessity of it)
- FDA review timelines
- Patent litigation and settlements
- Pharmacy benefit managers serving as private-label biosimilar manufacturers
- Employers awakening to the value of biosimilars
All of these major themes have evolved and shaped how the US healthcare system views, utilizes, and covers biosimilar agents in the oncology, autoimmune, diabetes, and ophthalmology spaces to date.
The regulation, marketing, and clinical testing of agents that are biosimilar to “innovator” or “reference” products has been extremely unsettled. BR&R provides education, commentary, and updates on the biosimilar marketplace. Our coverage of biosimilar news includes:
- Biosimilar drug research and clinical trial development
- Biosimilar blogs, biosimilar posts, and other commentary
- FDA approvals
- Regulatory issues
- Biosimilar news on financing, meeting highlights, and 351(k) applications
- Contracting/rebating/pricing
- Product launches
- Tracking of biosimilar utilization
