Amgen 2011 Annual Report Download - page 44

• duration of treatment with the product;
• seriousness of known or potential adverse events associated with the product; and
• whether the product is a new molecular entity.
All REMS are required to have a timetable for assessment and may have one or more of the following:
• distribution of a medication guide or a patient package insert to patients;
• communication plan for the healthcare provider or institution, such as a Dear Healthcare Professional
Letter;
• elements to assure safe use including, but not limited to:
Ospecific training, experience or certification for prescribers;
Ocertification of medication dispensing sites and dispensing in limited settings;
Omonitoring of specific patients; and
Oenrollment of patients in a registry.
Each REMS is unique and varies depending on the specific factors required. While the elements of REMS
may vary, all REMS require the sponsor to submit periodic assessment reports to the FDA to demonstrate that
the goals of the REMS are being met. Failure to comply with a REMS, including submission of a required
assessment or any modification to a REMS, may result in substantial civil or criminal penalties and can result in
additional limitations being placed on a product’s use and, potentially, withdrawal of the product from the
market. We currently have approved REMS for our ESAs, Prolia®and Nplate®. As REMS are relatively new, the
FDA and sponsor companies continue to learn how best to implement, operate and monitor the effectiveness of
REMS, and the requirements of our REMS and those of other companies may change over time.
Adverse events that are reported after marketing approval also can result in additional limitations being
placed on a product’s use and, potentially, withdrawal of the product from the market. The FDA has authority to
mandate labeling changes to products at any point in a product’s lifecycle based on new safety information or as
part of an evolving label change to a particular class of products.
The FDA also uses various advisory committees of external experts to assist in its mission to protect and
promote the public health, to obtain independent expert advice on scientific, technical and policy matters. The
committees are generally advisory only and FDA officials are not bound to or limited by their recommendations.
We have participated in meetings of the ODAC, the Cardiovascular and Renal Drug Advisory Committee and the
Advisory Committee for Reproductive Health Drugs, among others, to address certain issues related to our
products, including Aranesp®, EPOGEN®, Prolia®and XGEVA®.
FDA Approval of Biosimilar Products. The U.S. healthcare reform law authorizes the FDA to approve
biosimilar products under a separate, abbreviated pathway. The new law establishes a period of 12 years of data
exclusivity for reference products in order to preserve incentives for future innovation and outlines statutory
criteria for science-based biosimilar approval standards that take into account patient safety considerations.
Under this framework, data exclusivity protects the data in the innovator’s regulatory application by prohibiting
others, for a period of 12 years, from gaining FDA approval based in part on reliance or reference to the
innovator’s data in their application to the FDA. The new law does not change the duration of patents granted on
biologic products. On February 9, 2012, the FDA released three draft guidance documents as part of the
implementation of the abbreviated approval pathway for biosimilar products. While FDA guidance documents
are not legally binding on the public or on the FDA, they indicate the FDA’s views on a subject. The draft
guidance documents provide insight to the FDA’s current thinking on the development of biosimilar products and
address a range of technical, scientific and regulatory issues. The guidance documents generally provide that, for
approval, a sponsor must demonstrate that the proposed product is “biosimilar” to a single reference product
already licensed by the FDA. In assessing biosimilarity, the FDA indicated that it intends to use a risk-based
“totality of the evidence” approach to evaluate all available data submitted by the applicant. Generally, a
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