Biosimilars Forum Statement at FDA’s BsUFA III Kick-off Meeting

Good morning everyone.

I’m Meaghan Rose Smith, Executive Director of the Biosimilars Forum and my remarks represent the views of our ten members who manufacture and market biosimilar products.

The Biosimilars Forum is a non-profit organization with a mission to promote biosimilar education and support advancement of policies that will sustain a robust, biosimilar market in the United States to lower costs. Our goal is to expand access and availability of biosimilars that improve health care treatment options.

The Forum very much appreciates the opportunity to provide our perspective on the progress FDA and industry have collectively achieved on the BsUFA II commitments and the exciting opportunities that we hope to work with FDA on through the next iteration of the BsUFA program.

We want to thank FDA staff for their diligent work toward meeting the goals laid out in the BsUFA II commitment letter to advance a robust biosimilars program. We appreciate how the COVID-19 work has necessarily taken priority in these last 8 or so months and may have created challenges for FDA staff supporting biosimilars – as staff are called away on COVID-related assignments.

Under BSUFA II, much progress has been made in implementing a regulatory framework, evidentiary standards, and development programs for biosimilars. For example, FDA has been:

Establishing dedicated staff capacity for key functions such as policy development;
Issuing guidance on topics listed in the commitment letter and we know there may be others in the pipeline; and
Building public education campaigns around the safety and benefits of biosimilars that have reached a wide variety of clinicians, patients, employers and other key stakeholder groups.

It is our hope that under BSUFA III, even under current circumstances, we can continue to significantly advance biosimilars development and availability for patients. We must continue to advance the efficiency of the regulatory processes and ensure that regulatory guidance addresses key areas that will improve the stability and future growth of the biosimilars market.

Today, I want to highlight several such areas for which the Biosimilars Forum is particularly interested in working with FDA to advance in BsUFA III.

First, we must continue the commitment to enhance the efficiency and utility of meetings and communications between the FDA and industry. Active communication with the FDA during application review can heighten the efficiency of the 351(k) BLA review process and contribute to higher first-cycle approval rates. A transparent, predictable, and consistent review process is critically important to building successful biosimilar development programs. FDA guidance and advice received during development meetings help biosimilar sponsors avoid studies and analyses that would not support regulatory approval and at the same time provide crucial information to strengthen other global development programs that sponsors will pursue.

Increasing opportunities for industry to gain clarity on FDA’s expectations throughout the process can minimize challenges that may emerge in later stages of development. Among the improvements we hope to work on with the FDA are to establish a new or otherwise modify existing pre-or early development meetings, to help ensure that development programs are on the right track from the start thereby avoiding unnecessary delays. We also see value in creating mechanisms for industry to obtain clarification of FDA advice or comments that occur during FDA-sponsor meetings, since we often need time to review FDA feedback with a more expansive internal team. Further, we believe we must continue to work towards aligning the Type 4 meeting processes for originator biologics and biosimilars.

If structured correctly, we believe modifications to meetings management and communications can result in a more efficient use of FDA resources, and enhance Agency staff productivity. We are committed to working with FDA on these concepts to bring them forth under BsUFA III.

Next, while FDA has published several guidance documents related to biosimilars, industry continues to struggle with the lack of clarity regarding the Agency’s policy on certain aspects of interchangeability as well as regulatory expectations for certain post-approval changes for biosimilar or interchangeable products. For example, the FDA has issued several biosimilar guidances that have explicitly excluded interchangeable biologics. We appreciate that these exclusions may have been necessary at that time because the initial core interchangeability guidance had not yet been issued. However, it is now an appropriate time to fill in these gaps.

With respect to post-approval changes, in FDA’s February 2020 guidance the Agency proposed to review supplements to a licensed 351(k) BLA within a 6-month time period. In separate guidance, the Agency addresses review timeframes for updates to safety labeling. It would be helpful if FDA would take another look at the timelines in these guidances, as we would recommend the timelines be determined by the specific type of post-approval change.

Additionally, as FDA stated in its Biosimilars Action Plan, scientific and regulatory clarity is critical for biosimilars development. In the past decade since the biosimilar pathway was established in the US, we have gained significant experience with biosimilars in the US and elsewhere. Building on this knowledge, we want to work towards creating more streamlined processes and have guidance that keeps pace with regulatory science and provides patients timely access to products. As we move into the third iteration of BsUFA, the Forum believes it is the appropriate time to establish a more streamlined and collaborative platform to examine scientific issues that could inform future changes to the program. We are hopeful to work with FDA to develop a regulatory science initiative that will capitalize on the current science around biosimilars and help advance public health by providing access to safe and effective biosimilar products.

Lastly, in light of the FDA’s postponement of most foreign inspections due to COVID-19, the Forum believes it would be important to discuss a more active implementation of the Mutual Recognition Agreement (MRA) with the EU for pre-approval inspections. In this way, we hope to alleviate any delays and work towards continued provision of affordable, life-saving biosimilar products to patients despite the challenges imposed by the COVID-19 pandemic.Thank you again for the opportunity to speak today. We are committed to working with the Agency and other stakeholders to ensure that patients have high-quality, safe, effective, and more affordable medicines.