Biosimilars Forum Letter to Senate HELP Committee on FDA User Fee Agreements
The Biosimilars Forum submitted the following letter to the U.S. Senate Committee on Health, Education, Labor & Pensions in advance of the hearing FDA User Fee Agreements: Advancing Medical Product Regulation and Innovation for the Benefit of Patients. In the letter, Biosimilars Forum executive director Juliana M. Reed reiterated the Forum’s support for the negotiated BsUFA III agreement. Reed also noted that lawmakers and regulators must address the delayed biosimilars inspections and backlogs to ensure swift approvals and increased access to these effective, lower-cost prescriptions.
Chairwoman Murray, Ranking Member Burr and members of the committee –
On behalf of the Forum members, I would like to thank you for considering this letter in advance of the hearing “FDA User Fee Agreements: Advancing Medical Product Regulation and Innovation for the Benefit of Patients.”
The Biosimilars Forum is the non-profit trade association representing the companies with the most significant U.S. biosimilars development portfolios, including: Biogen, Boehringer Ingelheim, Coherus BioSciences, Organon Inc., Pfizer Inc., Samsung Bioepis, Sandoz, Teva, and Viatris. This letter represents the views of our members, all of whom manufacture or market biosimilar products in the US as well as other parts of the world.
Biosimilars have the potential to provide very significant health care savings in the U.S. Without robust competition, innovator biologics will continue to represent approximately 40 percent of total prescription drug spending while they represent only 4 percent of the medicines prescribed to patients. Biosimilars provide competition to allow Americans access to lower-cost biologic alternatives, and their timely licensure and launch is vital to ensuring patient access to lower cost biologic medicines.
The Biosimilars Forum is supportive of the negotiated BsUFA III agreement, and we believe it represents important progress in facilitating timely access to safe and effective biosimilar medicines for patients. We are pleased the commitment letter codifies review timelines for labeling supplements, provides meeting management enhancements, and promotes best practices of communication between FDA and sponsors.
The Forum is particularly pleased that the BsUFA III program will include a regulatory science program that can help bring more biosimilars to market faster. Since the BPCIA was enacted over a decade ago, there have been many advances in the science of developing biological drugs. The regulatory science program will provide FDA and industry the ability to incorporate the latest scientific innovations into biosimilar development and regulation.
Although we are very satisfied with the progress represented in the BsUFA III commitment letter, we want to stress that the pandemic has impacted biosimilars and patient access disproportionately hard for almost two years. COVID-19 has stalled on-site inspections for biosimilars delaying their approvals.
While biosimilar inspections have been delayed over the past two years, on-time actions for the GDUFA and PDUFA programs have averaged over 90%; and the BsUFA program, plunged to 75% during Quarter 4 of FY 2020, and further dropped to 67% during Quarter 1 of FY 2021 and it remains at 67% today. In addition, per the Agency’s May 2021 Roadmap for FDA Inspection Oversight, biosimilar inspections are not, considered to be “mission critical” and thus are not prioritized. This has the ultimate outcome of slowing timely approvals of biosimilars. We would like to ask the FDA for clarity to sponsors and the public as to the estimated timelines the FDA believes it will take to address the backlog in inspections and reviews and why biosimilars are not prioritized or treated equitably.
For the BsUFA III Commitment Letter to be a success the inspection backlog for biosimilars must be addressed and remote inspections be implemented consistently across all programs, biosimilars cannot remain a low priority for the Agency.
The Forum is encouraged by FDA’s commitment to hire and retain sufficient numbers and types of technical and scientific experts to efficiently conduct reviews and applauds the agency’s efforts to improve its use of data and technology. Industry understands FDA staff works on numerous types of applications, a small cadre of focused Biosimilar staff could help expedite the assessment and inspection process for Biosimilars. We will work with the FDA to determine how can we allocate reviewers specifically for BsUFA goals.
As we head into BsUFA III we look forward to working with the Agency to implement the commitment letter to the mutual benefit of biosimilar sponsors and FDA. We are committed to developing a robust biosimilar industry in the US, and to help the BsUFA program further develop over the next five years. We are at a critical inflection point for the biosimilars industry and we believe that enhancing the process for biosimilar development, review and educating the public of the importance of biosimilars is critically important to sustaining and cementing the biosimilar pathway for years to come, but as you all know, more needs to be done outside of BSUFA to help us all achieve our goal of lowering the costs of medicines and improving patient access to biosimilars.
To conclude, thank you for the opportunity to provide this letter. The Forum strongly supports efforts to advance the FDA’s biosimilars program. We need to see the FDA prioritize biosimilar inspections and continue their work to streamline the development of biosimilars as well as advance the guidances we need. Policies that support timely approval of biosimilars will ensure that patients have more access to high quality, safe, effective, and affordable biological therapies.
Juliana M. Reed
Executive Director, Biosimilars Forum