|
Abbvie Inc 's Comment on Competitors and Industry Peers
The markets for AbbVies products are highly competitive. AbbVie competes with
other research-based pharmaceuticals and biotechnology companies that discover,
manufacture, market, and sell proprietary pharmaceutical products and biologics.
For example, HUMIRA competes with a number of anti-TNF and other products that
are approved for a number of disease states and AbbVies virology products compete
with protease inhibitors and other anti-HIV treatments. The search for technological
innovations in pharmaceutical products is a significant aspect of competition.
The introduction of new products by competitors and changes in medical practices
and procedures can result in product obsolescence. Price is also a competitive
factor. In addition, the substitution of generic pharmaceutical products for branded
pharmaceutical products creates competitive pressures on AbbVies products that
do not have patent protection.
Biosimilars. Competition for AbbVies biologic products is affected by the
approval of follow-on biologics, also known as "biosimilars." Biologics
have added major therapeutic options for the treatment of many diseases, including
some for which therapies were unavailable or inadequate. The advent of biologics
has also raised complex regulatory issues and significant pharmacoeconomic concerns
because the cost of developing and producing biologic therapies is typically
dramatically higher than for conventional (small molecule) medications, and
because many expensive biologic medications are used for ongoing treatment of
chronic diseases, such as rheumatoid arthritis or inflammatory bowel disease,
or for the treatment of previously untreatable cancer. Significant investments
in biologics infrastructure and manufacturing are necessary to produce biologic
products, as are significant investments in marketing, distribution, and sales
organization activities, which may limit the number of biosimilar competitors.
In the United States, the FDA regulates biologics under the Federal Food,
Drug, and Cosmetic Act, the Public Health Service Act, and implementing regulations.
While the enactment of federal health care reform legislation in March 2010
was meant to provide a pathway for approval of biosimilars under the Public
Health Service Act, recent regulatory guidance suggests that the approval process
for biosimilars will be far more extensive than the approval process for generic
or other follow-on versions of small molecule products, in order to ensure that
the safety and efficacy of biosimilars is highly similar to that of an original
biologic, such as HUMIRA. Ultimate approval by the FDA is dependent upon many
factors, including a showing that the biosimilar is "highly similar"
to the original product and has no clinically meaningful differences from the
original product in terms of safety, purity, and potency. The types of data
that could ordinarily be required in an application to show similarity would
include analytical data and studies to demonstrate chemical similarity, animal
studies (including toxicity studies), and clinical studies. Applicable regulations
also require that the biosimilar must be for the same indication as the original
biologic and involve the same mechanism of action, and that the manufacturing
facility meets the standards necessary to assure that the biosimilar is safe,
pure, and potent.
Furthermore, the new law provides that only a biosimilar product that is deemed
to be "interchangeable" may be substituted for the original biologic
product without the intervention of the health care provider who prescribed
the original biologic product. To prove that a biosimilar product is interchangeable,
the applicant must demonstrate that the product can be expected to produce the
same clinical results as the original biologic product in any given patient,
and if the product is administered more than once in a patient, that safety
risks and potential for diminished efficacy of alternating or switching between
the use of the interchangeable biosimilar biologic product and the original
biologic product is no greater than the risk of using the original biologic
product without switching. The new law is only beginning to be interpreted and
implemented by the FDA. As a result, its ultimate impact, implementation, and
meaning will likely be subject to substantial uncertainty for years to come.
| |