David Gaugh, Senior Vice President, Sciences and Regulatory Affairs, GPhA, Remarks on BsUFA

PRESS RELEASE

WASHINGTON, DC (Oct. 20, 2016) —

As prepared for the October 20, 2016 Food and Drug Administration (FDA) Biosimilar User Fee Act Public Meeting

“I am David Gaugh, Senior Vice President of Sciences and Regulatory Affairs at the Generic Pharmaceutical Association (GPhA) and the Biosimilars Council (Council) and a licensed pharmacist. GPhA represents the manufacturers and distributors of finished dose generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending.

The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of these more affordable alternatives to costly brand biologic medicines. We represent manufacturers who currently product high-quality, safe and effective biosimilars approved in the U.S., Europe and other regulated markets around the world.

Biologic medicines are often the only lifesaving treatments for many of the most severe diseases encountered by patients today. In many respects, they represent the future of medicine. Their high price tag, however, can keep them out of reach for many patients.

During negotiations the Council focused on a number of Key Goals:

• Additional Staff

• Finalize outstanding policy guidance

• Increased communications with applicants

• Biosimilars Public Education

The Council and GPhA believe that the agreements reached will strengthen the BsUFA program and will specifically address the key goals we outlined.

The Council expressed its enthusiastic support for user fee funding to provide FDA with additional resources to apply consistent regulatory standards to all biologics, including both originators and biosimilars, and to review new applications thoroughly and in a timely manner. Both industry and patients will benefit from this user fee program by gaining a higher degree of certainty in the timeliness of application reviews.

We applaud the FDA for recognizing the importance of biosimilars, and the need to apply state-of-the-art science in all agency activities governing the review and approval of these important drugs. While the FDA has set a promising foundation, fewer biosimilars are approved today than originally projected. BsSUFA II is designed to reverse this outcome.

The proposed reauthorization of BsUFA in BsUFA II will provide:

• Shifting from a 10 month to a 12 month review timeline in order to improve and increase opportunities for applicant touchpoints between industry and FDA, striving for 1st cycle review when possible

o The extended timeline will allow for increased communications and interactions between FDA and sponsor before and during the review process.

o FDA and sponsors are able to structure the nature and timing of communications and interactions by mutual agreement through a formal communication plan.

• Modification of the User Fee structure through a stand-alone fee model independent of PDUFA. Fees would be limited to a Biosimilar Development Program (BDP) fee, Reactivation fee, Application fee, and Product fee

• $20 million trigger remains but is modified to allow FDA 15% flexibility to ensure spending the funds and hiring to build the foundations for the program

o FDA will establish priorities for management of the metric goals for targeted hires within the biosimilar review program for BsUFA II. In particular, FDA will target hiring 15 FTEs in FY 2018, to enhance capacity for biosimilar guidance development, reviewer training, and timely communication

o FDA and industry want to ensure the program is adequately resourced. BsUFA II is no longer linked to PDUFA fee levels. FDA and industry also agreed that FDA should avoid accruing unnecessarily high carryover balances in BsUFA II and carryover balance funds should be used to mitigate substantial increases in fees caused by fluctuations in fee paying submissions year-to-year

• FDA is committed to enhancing management of BsUFA resources in BsUFA II

o FDA will conduct activities to develop a resource capacity planning function and modernized time reporting approach in BsUFA II

o Include inflation and workload adjustments, carryover balance, and method for setting target allocation

• FDA will work towards the goal of publishing revised draft guidance

o Final guidance documents on or before May 31, 2019 for draft guidances published between January 1, 2014 and September 30, 2017

• Reduction of the scheduling timelines for BIA meetings from 90 to 75 days

• Increasing the scheduling timeline of BDP2 meetings from 75 to 90 days to allow for a more robust conversation between applicant and FDA

• Manufacturing supplements that require prior approval (PAS) subject to a 4-month review

FDA and industry need to continue to work to create a public education campaign around the benefits of biosimilars. These educational efforts will provide a key source of information regarding biosimilar products, their safety and scientific development. Additionally, other key stakeholders (e.g., payers, patients, clinicians) should contribute to educational efforts.

Moving forward, it is critical for FDA and industry to continue our discussions strengthening the biosimilars review infrastructure and expertise at FDA. Together we can promote access to more affordable, high quality biosimilars for the patients who rely on these essential medicines.”