Amgen 2010 Annual Report Download - page 65

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»pharmacovigilance program. (See Our ESA products continue to be
under review and receive scrutiny by regulatory authorities.) 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 may have a material adverse
effect on 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 which could impact our profitability.
We currently face competition in Europe from biosimilar products, and we expect to face increasing
competition from biosimilars in the future. Lawmakers in the United States have recently 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. Some companies have received
and other companies are seeking approval to market erythropoietin and G-CSF biosimilars in the EU, presenting
additional competition for our products. (See Our marketed products face substantial competition.) For example,
following the expiration of the principal European patent relating to recombinant G-CSF in August 2006, the EC
issued marketing authorizations for the first G-CSF biosimilar products and the products were launched in certain
EU countries in 2008 and 2009. There are now several G-CSF biosimilars available in the EU marketed by different
companies and these G-CSF biosimilar products compete with NEUPOGEN»and Neulasta». Further, as in an effort
to reduce costs, countries in the EU may in the future permit the automatic substitution by pharmacists of
biosimilars for the corresponding innovator products. We cannot predict to what extent the entry of biosimilar
products or other competing products will impact future sales of our products in the EU. Our inability to compete
effectively could reduce sales, which could have a material adverse effect on our results of operations.
On March 23, 2010, President Obama signed into law the PPACA which authorized the FDA to approve
biosimilar products under a new abbreviated pathway. The new law established a period of 12 years of data
exclusivity for reference products in order to preserve incentives for future innovation and outlined 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, for a period of
12 years, others 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. As part
of the implementation process, the FDA published several questions in the Federal Register for public comment.
The FDA held a public meeting in November 2010 to seek stakeholder input on the subject and accepted written
comments through 2010. The agency has the authority to approve biosimilar products but has not announced
whether it will first publish guidance or rules for biosimilar applicants before approving biosimilar products. With
the likely introduction of biosimilars in the United States, we expect in the future to face greater competition from
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