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new types of therapeutic biological products have been approved for the
treatment of diseases. Hence, there is a desire to make generic biological
products (i.e., biosimilars) available. An approval pathway for biosimilars was
created by the health care legislation--the Patient Protection and Affordable
Care Act. In this Analysis, Brian R. Dorn Ph.D. and Katherine M. Kowalchyk
Ph.D. provide an overview of the key provisions of the law including
definitions of terms, required information, exclusivity, and patent disputes.
term "biosimilar" is used to describe the proposed biological generic
drug because the biosimilar product does not have to be identical to the
approved product. The legislation defines a "biosimilar" biological
product as (a) highly similar to the approved product notwithstanding minor
differences in clinically inactive components and (b) having no clinically
meaningful differences as compared to the approved product in terms of safety,
purity, and potency. Before such an approval process can be implemented, the
meaning of these terms will need to be established. "Highly similar"
will need to be defined with regard to both structural and functional
characteristics of the biosimilar product as compared to the approved
legislation also establishes a complicated regime of information exchanges and
tight deadlines relating to any lawsuit concerning patents that cover the
approved product between the biosimilar applicant and the approved biologic
product sponsor (i.e., the entity approved to make and distribute the biologic
product). Patents on approved biological products that cover the active
ingredient, formulation, or method of treatment as well as the method of
producing the biologic product can be litigated.
this law, there will be no Orange Book (the FDA's Approved Drug Products with
Therapeutic Equivalence Evaluations) listing for biologic products. The Orange
Book lists patents on approved non biological prescription drugs that cover the
active pharmaceutical ingredient, formulation, or method of treatment. Instead,
the biosimilar applicant must provide the approved biologic product sponsor
with a copy of the FDA application and information regarding the biosimilar
product and its production. This exchange of information starts the procedure
of multiple exchanges of confidential information and patent lists. During
these exchanges, each side must provide the other side with a detailed
statement that describes the legal and factual basis of validity,
enforceability, and infringement of any patents listed on a claim by claim
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