AAM & Biosimilars Council Comments Regarding FDA-2018-N-2689

Friday September 21, 2018

The Association for Accessible Medicines (“AAM”), and its Biosimilars Council (“Council”) (collectively referred to in these comments as AAM), are pleased to provide comments to the FDA regarding the biosimilars action plan and ways to facilitate competition in this critical industry.

AAM represents the manufacturers and distributors of finished generic pharmaceutical products, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic pharmaceutical industry. Generics represent greater than 90% of all prescriptions dispensed in the U.S. by volume, but only 23% of the cost expended on prescription drugs. AAM is the sole association representing America’s generic pharmaceutical sector in the United States. The Council, a division of AAM, works to ensure a positive regulatory, reimbursement, political and policy environment for biosimilar products, and educate stakeholders and patients about the safety and effectiveness of biosimilars. Member organizations include companies and stakeholder organizations working to develop biosimilar products with the intent to participate in the U.S. market.

AAM appreciates and supports FDA’s continued efforts to foster biosimilar competition in the interest of building a sustainable marketplace for these new medicines for America’s patients. Absent additional measures to build healthy biosimilar competition, AAM and its members are concerned that the development of this nascent industry is in jeopardy, a perspective echoed by Commissioner Gottlieb when he noted, “Our ability here at the FDA to build a market of safe, effective biosimilar products is key for patients, and its key for the nation’s health care system. It’s also a key to us to promoting access and reducing health care costs. And it’s a key to
advancing public health. But we are worried, and I’m worried in particular, that the market for these products is still not firmly established. And the ability of these products to penetrate clinical practice and gain acceptance in clinical practice isn’t yet firmed up. That doesn’t mean that the future doesn’t hold a lot of promise for biosimilars. It just means in my view that the future is uncertain, and the policy, and the regulatory decisions that we make, here in the present day, are going to have a lot to do with whether or not we realize the promise from this new category of products. Or whether we see the opportunities we once envisioned from biosimilars, go unrealized.”

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