Biosimilars: Enacted Legislation for an Approval Pathway

Many 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. They write:

II. Definitions

     The 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 biological product.

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V. Patent Disputes

     This 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.

     Under 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 basis.

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