Amgen 2011 Annual Report Download - page 67

Patients may also suffer adverse medical events or side effects in the course of our, our licensees, partners
or independent investigators’ clinical trials which could:
• delay the clinical trial program;
• require additional or longer trials to gain approval;
• prohibit regulatory approval of our product candidates or new indications for existing products; and
• render the product candidate commercially unfeasible or limit our ability to market existing products
completely or in certain therapeutic areas.
Safety signals, trends, adverse events or results from clinical trials or studies performed by us or by others
(including our licensees or independent investigators) or from the marketed use of our drugs or similar products
that result in revised safety-related labeling or restrictions on the use of our approved products could negatively
impact healthcare provider prescribing behavior, use and sales of our products, regulatory or private health
organization medical guidelines and reimbursement for our products, all of which could have a material adverse
effect on our business and results of operations.
Clinical trials must be designed based on the current standard of medical care. However in certain diseases,
such as cancer, the standard of care is evolving rapidly. In these diseases, the duration of time needed to complete
certain clinical trials may result in the design of such clinical trials being based on an out of date standard of
medical care, limiting the utility and application of such trials. We may not obtain favorable clinical trial results
and may not be able to obtain regulatory approval for new product candidates, new indications for existing
products or maintenance of our current labels on this basis. Further, clinical trials conducted by others, including
our licensees, partners or independent investigators, may result in unfavorable clinical trials results that may call
into question the safety of our products in off-label or on label uses that may result in label restrictions and/or
additional trials.
Even after a product is on the market, safety concerns may require additional or more extensive clinical
trials as part of a pharmacovigilance program of our product or for approval of a new indication. For example, we
have initiated Study ‘782 as part of our Aranesp®oncology pharmacovigilance program. (See Our ESAs
continue to be under review and receive scrutiny by regulatory authorities.) In connection with the June 2011
ESA label changes, we also agreed to conduct additional clinical trials examining the use of ESAs in CKD.
Additional clinical trials we initiate, including those required by the FDA, could result in substantial additional
expense and the outcomes could result in additional label restrictions or the loss of regulatory approval for an
approved indication, each of which could have a material adverse effect on the sales of our products, our business
and results of operations. Additionally, any negative results from such trials could materially affect the extent of
approvals, the use, reimbursement and sales of our products.
We expect to face increasing competition from biosimilar products.
We currently face competition in Europe from biosimilar products, and we expect to face increasing
competition from biosimilars in the future. In 2010, lawmakers in the United States enacted healthcare reform
legislation which included an abbreviated regulatory pathway for the approval of biosimilars. The EU has already
created such a regulatory pathway. To the extent that governments adopt more permissive approval frameworks
and competitors are able to obtain broader marketing approval for biosimilars, our products will become subject
to increased competition. Expiration or successful challenge of applicable patent rights could trigger such
competition, and we could face more litigation regarding the validity and/or scope of our patents.
In the EU, the EC has granted marketing authorizations for several biosimilars pursuant to a set of general
and product class-specific guidelines for biosimilar approvals issued over the past few years. In 2006, the EMA
developed and issued final regulatory guidelines related to the development and approval of biosimilar products.
The final guidelines included clinical trial guidance for certain biosimilar products, including erythropoietins and
G-CSFs, recommending that applicants seeking approval of such biosimilar products conduct pharmacodynamic,
toxicological and clinical safety studies as well as a pharmacovigilance program. In late 2011, the EMA
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