Biosimilars industry weighs in on BsUFA II interim assessment

Regulatory NewsRegulatory News | 02 April 2021 |  By 

Three biopharmaceutical trade associations have weighed in with generally positive positions on an interim assessment of how the US Food and Drug Association has fared in its efforts to increase transparency and improve communication in its process for reviewing and approving biosimilars.
The comments follow a 27 January public meeting hosted by FDA that shared results of an external review of the agency’s Program for Enhanced Review Transparency and Communication for 351(k) Biologics License Applications (BLAs), the regulatory pathway for biosimilar approvals. The interim assessment was part of FDA’s commitments under the Biosimilar User Fee Act for fiscal years 2018-2022 (BsUFA II).
The Pharmaceutical Research and Manufacturers of America (PhRMA) was one of four groups that submitted comments following the BsUFA interim assessment meeting.
PhRMA cited market research showing that by midway through 2020, total savings from biosimilars amounted to $6.5 billion. The pace of savings is projected to mushroom, reaching $100 billion over the next 5 years, noted PhRMA.
“PhRMA is encouraged by the independent contractor’s preliminary conclusion that the Program has created conditions that enhance the ability of sponsors and FDA reviewers to work toward application approval in the first review cycle,” wrote the group.
In the first of three additional points made in its commentary, PhRMA concurred with the independent reviewers’ assessments that FDA should move toward “[e]stablishing the process of providing pre-submission advice and templates for application content and organization as a good practice for the Biosimilar Biological Product Development (BPD) Type 4 Meeting.” FDA should also allow time in Late-Cycle Meetings for issues and discussion topics identified by the sponsor, and extending the information response window beyond 2 days “when feasible.”
Also, PhRMA asked FDA to pay attention to the specifics of feedback from sponsors who were asked about potential improvements to the approval process. “Regarding information requests, PhRMA notes the importance of providing early notice of issues, including providing advance notice of the likelihood of an information request and bundling information requests when possible,” wrote the group, adding that it would also be helpful to know when FDA considers an information request or a substantive issue resolved.
Finally, PhRMA lauded FDA for accomplishing its inspections earlier in the review cycle, with 100% of inspections completed within 10 months of FDA’s receipt of applications. This time frame meets targets.
Looking ahead to the final assessment of FDA’s enhanced transparency and communication program, “PhRMA urges further investigation of preliminary findings and trends outlined in the Interim Assessment, including review process attributes and application attributes that may influence first-cycle approval.”
The Biosimilars Forum also submitted commentary following the meeting, kicking off its letter by acknowledging that FDA’s biosimilars work largely stayed on track despite 2020’s “extremely challenging conditions.” Inspection backlogs have been “the most challenging aspect of the Agency’s working model during the pandemic,” noted the Forum.
This industry group concurred with PhRMA that the uptick in first-cycle approvals in BsUFA II represents a positive trend. “First-cycle approvals may be the most important factor in ensuring the predictability of the regulatory program for biosimilars.”
The Biosimilars Forum letter also shared some individual members’ experiences with BLA review and approval delays, noting that members hope that “newer approaches” to facilitate inspections “could lead to fewer missed goals, fewer complete response letters due solely to the lack of inspections, and clearing the inspection backlog faster once the pandemic subsides.”
Another point raised by the Biosimilars Forum is that the independent review also offered the perspective of FDA staff, in addition to drawing on feedback from industry. Internal recommendations, if adopted, would also help clear the way to more efficient reviews, said the Forum. Efficiency and open communication channels are a shared goal, they added: “Generally, we think all sponsors of FDA-regulated products from new drugs, to generics, to biosimilars would concur that increasing the overall predictability, consistency, and transparency of the review process is a good thing.”
The Biosimilars Council, a division of the generics industry’s Association for Accessible Medicines (AAM), also weighed in, noting that though first-cycle approvals have increased, it is not known whether industry’s increased experience and efficiency with the BLA process might be a major contributor. Nevertheless, this group called the boost in first-round reviews a “win-win-for all, including the FDA, manufacturers, and especially patients who have greater timely access to more affordable high-quality biosimilar medicines.”
The Biosimilars Council plans to weigh in more substantively in BsUFA III negotiations.


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