AMCP Supports Expedited FDA Approval Process for Biosimilars


The Academy of Managed Care Pharmacy today supported the U.S. Food and Drug Administration's use of "an expedited approval process" for biosimilars to encourage the development of both new and more affordable treatments for such serious conditions as cancer, multiple sclerosis and rheumatoid arthritis.

Alexandria, Va. — The Academy of Managed Care Pharmacy today supported the U.S. Food and Drug Administration’s use of “an expedited approval process” for biosimilars to encourage the development of both new and more affordable treatments for such serious conditions as cancer, multiple sclerosis and rheumatoid arthritis.

“AMCP supports an expedited approval process for biosimilars that encourages innovation and balances the public’s interest in ensuring safety, efficacy and affordability,” AMCP CEO Edith A. Rosato, RPh, IOM, commented. “As Europe’s experience demonstrates, biosimilars could be an important tool for bending the health care cost curve without compromising quality.”

Excerpts from the Academy’s statement to the FDA’s Oncologic Drugs Advisory Committee Meeting follow:

The Academy believes that an expedited approval process for biosimilar products provides a needed incentive for the development of new therapeutic products that hold the promise of preventing, treating or curing otherwise inevitable, untreatable and incurable diseases. Such a process will help ensure greater access to new therapies at costs expected to be below those of an FDA-approved biological product (a “reference product”).

It is important for the approval process to support an appropriate balance between bringing safe and effective drugs to market and maximizing patient access to affordable drugs. The regulatory process must be designed to rigorously examine the safety and efficacy of a biosimilar applicant, but not prove so burdensome in either the length of time required for review or in added costs for the manufacturer seeking the biosimilar license that manufacturers are discouraged from filing for approval. To this end, the FDA should determine on a case-by-case basis whether to require additional clinical studies prior to approval, as well as any postmarketing studies to be conducted after approval.

Manufacturers of approved biosimilars should be allowed to use the same government- approved name/international nonproprietary name as the reference product (e.g. epoetin alpha for Procrit®). This will hopefully ease confusion among prescribers and patients, and help to encourage substitution of biosimilar products in appropriate instances. However, it is also important to continue to use current mechanisms such as manufacturer name, national drug code (NDC) numbers and lot numbers to effectively differentiate batches for safety monitoring purposes.

[T]he FDA should provide clear rules for the designation of a biosimilar product as interchangeable with a reference product, similar to the current “AB” ratings used for small-molecule chemical with the first step determining the biosimilarity of an applicant product and the second step determining the interchangeability of the biosimilar with the reference product. A determination of interchangeability should not be a requirement as a condition for approval of a biosimilar product. AMCP believes states should follow the FDA’s determination of interchangeability with regards to granting substitution authority to pharmacists. …

Finally, the approval of biosimilars should occur with the knowledge that postmarketing surveillance systems are available to monitor safety and efficacy in large populations. These reporting systems will supplement the voluntary reporting systems, but minimize the unknown bias that exists with such voluntary reporting systems.

A copy of AMCP’s submission may shortly be found at

About AMCP

The Academy of Managed Care Pharmacy is a national professional association of pharmacists and other health care practitioners who serve society by the application of sound medication management principles and strategies to improve health care for all. The Academy's 7,000 members develop and provide a diversified range of clinical, educational and business management services and strategies on behalf of the 200 million Americans.


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