Amgen 2007 Annual Report Download - page 35

financial and human resources than we do. In addition, the introduction of new products or the development of new
processes by competitors or new information about existing products may result in product replacements or price
reductions, even for products protected by patents. Further, the development of new treatment options or standard of
care may require less use of our products, particularly in supportive cancer care. For example, the development of
new treatments for cancer, such as targeted therapies including monoclonal antibodies, or chemotherapy regimens
that are less myelosuppressive may require less Aranesp®or Neulasta®/NEUPOGEN®.
We expect to face increasingly intense competition, including new and existing technologies and com-
petitive pressures associated with biosimilar and other products. For example, our principal European patent
relating to erythropoietin expired on December 12, 2004 and our principal European patent relating to G-CSF
expired on August 22, 2006. As these patents have expired, some companies have and other companies may re-
ceive approval for and market biosimilar products and other products to compete with our products in the EU,
presenting additional competition to our products, as discussed further below. (See “Item 1A. Risk Factors — Our
marketed products face substantial competition and other companies may discover, develop, acquire or commer-
cialize products before or more successfully than we do.”) In 2006, the EMEA developed and issued final
regulatory guidelines related to the development and approval of biosimilar products. The final guidelines in-
cluded clinical trial guidance for certain biosimilar products including erythropoietins and G-CSFs, which
guidance recommends that applicants seeking approval of such biosimilar products conduct fairly extensive
pharmacodynamic, toxicological, clinical safety studies and a pharmacovigilance program. In the United States,
there currently is no legal approval pathway for the approval of BLAs for biosimilars. A number of events would
need to occur before these products could enter the market, including passage of legislation by Congress to create
a new approval pathway and, depending on the specific provisions of any such legislation, promulgation of asso-
ciated regulations or guidance by the FDA. In 2007, several members of Congress expressed interest in the issue,
a number of bills were introduced, the House of Representatives and the Senate held hearings on biosimilars and
the Senate Committee on Health, Education, Labor, and Pensions (“HELP”) voted on legislation in June 2007.
However, no final legislation was passed in either chamber of Congress. Given the continuing interest of Con-
gress in the issue, it is possible legislation on biosimilars will also be considered in 2008. It is unknown what
type of regulatory framework, what legal provisions and what timeframes for issuance of regulations or guidance
any final legislation would contain. Until such legislation is created, we cannot predict when biosimilars could
appear in the United States. (See “Patents and Trademarks.”)
Some of our competitors are actively engaged in R&D in areas where we have products or where we are de-
veloping product candidates or new indications for existing products. For example, we compete with other
clinical trials for eligible patients, which may limit the number of available patients who meet the criteria for cer-
tain clinical trials. The competitive marketplace for our product candidates is significantly dependent upon the
timing of entry into the market. Early entry may have important advantages in gaining product acceptance, con-
tributing to the product’s eventual success and profitability. Accordingly, in some cases, the relative speed with
which we can develop products, complete the clinical testing, receive regulatory approval and supply commercial
quantities of the product to the market is expected to be important to our competitive position.
In addition, we compete with large pharmaceutical and biotechnology companies when entering into collabo-
rative arrangements with companies primarily in the biotechnology industry, research organizations and other
entities for the research, development and commercialization of technologies, product candidates and marketed
products. Other public and privately owned companies, research organizations, academic institutions and gov-
ernmental agencies conduct a significant amount of R&D in the biotechnology industry. We face competition in
our collaborative arrangements and licensing or acquisition activities from other pharmaceutical and bio-
technology companies that also seek to license or acquire technologies, product candidates or marketed products
from these entities. Accordingly, we may have difficulty entering into collaborative arrangements and licensing
or acquiring technologies, product candidates and marketed products on acceptable terms.
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