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.
Tag: biosimilars
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.
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.
Lower Costs for Biosimilar Development Will Yield Myriad Benefits: Part 2
The FDA's removal of the phase 3 trial requirement for biosimilars paves the way for lower development costs, opening opportunities for new entrants in the market. Formycon's FYB206, a pembrolizumab biosimilar, exemplifies this shift. Enhanced competition may lead to reduced prices and new biosimilar products being created.
Lower Costs for Biosimilar Development Will Yield Myriad Benefits: Part 1
At the Festival of Biologics in Basel, discussions centered on the removal of phase 3 trials for biosimilars, highlighting significant cost savings and its impact on competition. Experts emphasized the potential for biosimilars to enhance healthcare value, though access remains uneven. Regulatory changes could accelerate development and expand market opportunities for new entrants.
Does the Direct-to-Employer Route for Biosimilars Make Sense?
Employers have strongly indicated that they would like to move away from the big 3 PBMs for cost transparency and the ability to capture as much of the savings as possible themselves. Going the direct-to-employer route, as Waltz Health and Fresenius Kabi are doing, would seem a natural option. Waltz Health, a digital health company, … Continue reading Does the Direct-to-Employer Route for Biosimilars Make Sense?
Is the 505(b)2 Pathway Viable for Biosimilars?
With regulators focused on streamlining the 351(k) biosimilar development, it makes sense to wonder if the 505(b)2 pathway is valid for biosimilar approval. Can discussions about streamlining biosimilar development reach into abbreviated approval pathways for small molecules? Based on a Stat News webinar I attended yesterday, they already have. What exactly are the differences between … Continue reading Is the 505(b)2 Pathway Viable for Biosimilars?
The Second Entyvio Biosimilar Is Under Review at FDA
On July 31, Fresenius Kabi and Polpharma Biologics announced that its 351(k) application was accepted by both the FDA and the EMA for PB016, a proposed vedolizumab biosimilar candidate to Entyvio The second vedolizumab biosimilar candidate is now under review by the US FDA. On July 31, Fresenius Kabi announced that its 351(k) application was … Continue reading The Second Entyvio Biosimilar Is Under Review at FDA
MFP Agreements Don’t Guarantee Better Patient Access
A study by IQVIA finds that first prescription rejection rates were unchanged for the first MFP negotiated drugs after implementation in January. A notable study by IQVIA found that for the first drugs subject to Medicare maximum fair price (MFP) agreements, initial rejection rates were not significantly lower than before the new prices took effect … Continue reading MFP Agreements Don’t Guarantee Better Patient Access
Are Biosimilar Patient Copay Assistance Programs Lacking?
Our survey found that 87% of biosimilar products were associated with patient copay assistance programs that cut out-of-pocket costs to $5 or less. Physician perceptions of important financial assistance differences between biosimilars and reference products seem generally unfounded. The newly published edition of the Samsung Bioepis Biosimilar Market Report indicates that with few exceptions, biosimilar … Continue reading Are Biosimilar Patient Copay Assistance Programs Lacking?