Amgen 2010 Annual Report Download - page 20

pharmaceutical products may be based on, among other things, safety, efficacy, reliability, availability, patient
convenience/delivery devices, price, reimbursement and patent position and expirations.
Over the next several years, the existing patents on our principal products will begin to expire, and we expect to
face increasing competition thereafter, including from biosimilar products. A “biosimilar” product is a follow-on
version of another biological product for which marketing approval is sought or has been obtained based on a
demonstration that it is “highly similar” to the original reference product. This demonstration will typically consist
of comparative analytical, preclinical and clinical data from the biosimilar product to show that it has similar safety
and efficacy as the reference product. The 2010 U.S. healthcare reform legislation authorized the FDA to approve
biosimilar products under a new, abbreviated pathway. Consequently, we expect to face greater competition,
including from manufacturers with biosimilar products approved in Europe that may seek to quickly obtain
U.S. approval, subject to our ability to enforce our patents. In the European Union (“EU”), we are already facing
increasing competition from biosimilars given an established regulatory pathway for biosimilars in the EU.
Further, the introduction of new products or the development of new processes or technologies by competitors
or new information about existing products may result in increased competition for our marketed products, even for
those protected by patents, or in a reduction of price that we receive from selling our products. In addition, the
development of new treatment options or standards of care may reduce the use of our products, particularly in
supportive cancer care, or may limit the utility and application of ongoing clinical trials for our product candidates.
In addition to the challenges presented by competition, our existing products and product candidates are also
subject to increasing regulatory compliance requirements that could be imposed as conditions of approval or after a
product has been approved. This is increasingly true of new therapies with novel mechanisms of action. While such
therapies may offer important benefits and/or better treatment alternatives, they may also involve relatively new or
higher levels of scientific complexity and may therefore generate increased safety concerns. As a condition of
approval or due to safety concerns after a product has been approved, we may be required to perform additional
clinical trials or studies. A postmarketing requirement (“PMR”) is a trial or study that a sponsor company is required
by statute or regulation to conduct. A postmarketing commitment (“PMC”) is a trial or study that a sponsor
company agrees to in writing, but is not required by law, to conduct. We currently have PMRs or PMCs for a number
of our marketed products. In addition, we may be required to implement risk management plans for our products in
the various regions in which they are approved. For example, in 2008 the FDA began requiring REMS for various
approved products to ensure that the benefits of the drugs outweigh the risks. A REMS may also be imposed as a
condition of approval or after a product has been on the market. A REMS may include a medication guide or a
patient package insert, a healthcare provider communication plan or elements to assure safe use that the FDA deems
necessary. While the elements of REMS may vary, all REMS require the sponsor company to submit periodic
assessment reports to the FDA to demonstrate that the goals of the REMS are being met. The FDA evaluates such
assessments and may require additional modifications to the REMS elements. REMS may also be modified as the
FDA and companies gain more experience with REMS and how they are implemented, operated and monitored. We
currently have REMS for a number of our marketed products. (See discussion on PMRs, PMCs and REMS in
Government Regulation.)
ESAs
Aranesp»and EPOGEN»are our registered trademarks for darbepoetin alfa and Epoetin alfa, respectively,
both of which are ESAs, proteins that stimulate red blood cell production. Red blood cells transport oxygen to all
cells of the body. Without adequate amounts of erythropoietin, the red blood cell count is reduced. A deficient red
blood cell count can result in anemia, a condition in which insufficient oxygen is delivered to the body’s organs and
tissues. Anemia can be associated with chronic renal failure (“CRF”) in patients either on or not on dialysis.
Individuals with CRF suffer from anemia because they do not produce sufficient amounts of erythropoietin, which
is normally produced in healthy kidneys. Anemia can also result from chemotherapy treatments for patients with
non-myeloid malignancies.
ESA products, including ours, have faced and continue to face challenges. For example, based on adverse
safety results observed beginning in late 2006 in various ESA studies, performed by us and by others, that explored
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