Moving Toward a Biosimilars Pathway: The Lines are Drawn in Congress - The introduction of two rival bills has intensified the long-simmering debate on biosimilars regulation in the US. - BioPharm

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Moving Toward a Biosimilars Pathway: The Lines are Drawn in Congress
The introduction of two rival bills has intensified the long-simmering debate on biosimilars regulation in the US.


BioPharm International
Volume 22, Issue 7

Other Differences

There are several additional differences between the Waxman and Eshoo bills. For example, the Waxman bill would permit complete interchangeability of an approved biosimilar drug for the reference drug once the former has been approved by the FDA. This would allow substitution at the pharmacy level of the biosimilar as being equivalent to the branded drug unless a physician writes a prescription that contains a "no substitution" order, the same scenario as exists for small-molecule pharmaceuticals under Hatch-Waxman. In contrast, the Eshoo bill would not permit such outright interchangeability, and would only permit such substitution in a certain limited set of situations and only after the FDA has issued guidelines relating to the circumstances under which complete interchangeability of a biosimilar for a reference drug would be permitted. In addition, although the Waxman bill would permit the FDA to use the same official name for a biosimilar as for the reference biologic, the Eshoo bill would require the two biologic products to have different names. The bills also differ with respect to the "first-to-file exclusivity" accorded to the first applicant to receive approval for a biosimilar drug (i.e., the period during which the FDA cannot approve a second biosimilar application for the same biologic). The Waxman bill provides one year of first-to-file exclusivity and the Eshoo bill provides two years (although both are longer than the 180-day first-to-file exclusivity that is provided under Hatch-Waxman for small-molecule generic pharmaceuticals).

Patent Challenges

Finally, there is a significant difference in the mechanisms by which the two bills permit challenges to patents that may protect biologics or their methods of use or manufacture. Moreover, both these bills differ dramatically from the patent challenge mechanism provided for small-molecule pharmaceuticals under Hatch-Waxman. Neither of the biosimilar bills recently introduced into the House uses the "Orange Book" system that is familiar to those who work in the small-molecule generic pharmaceuticals environment under Hatch-Waxman. In that system, a pharmaceutical approval holder can submit a listing of patents to the FDA that the approval holder believes in good faith provide patent protection for the approved active pharmaceutical ingredient (API), an approved formulation containing the approved API, or an approved method of use (i.e., indication) of the approved API and/or approved formulation. Those patents would then be listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, commonly called The Orange Book. When a generic manufacturer submits an application for FDA approval of a generic version of the approved drug, formulation, or indication, the generic applicant must then certify to the FDA that: (1) there are no patents that encompass the generic drug to be approved; (2) any patents listed in The Orange Book that purport to cover the generic drug have already expired; (3) any patents listed in The Orange Book that purport to cover the generic drug would expire before the first date on which the generic applicant would market the generic version of the drug; or (4) that the patents listed in The Orange Book that purport to cover the drug compound, formulation or use either would not be infringed by the generic drug, or are invalid (a so-called "paragraph IV certification"). If its FDA application contains a paragraph IV certification, then the generic applicant must notify the approval holder and patentee of the filing of the generic application, and provide a statement of the reasoning for its patent certification; the approval holder/patentee then has 45 days to decide whether or not to sue the generic applicant for patent infringement. This process was designed to lead to more rapid adjudication of the patent exclusivity covering branded pharmaceuticals, and has been used with great success for the past 25 years.

In contrast, neither the Waxman nor the Eshoo biosimilars bill contains such an Orange Book mechanism for patent challenges. The Waxman bill permits a biosimilar applicant (or someone even just contemplating filing a biosimilar application) to request information from the approval holder on the reference biologic drug regarding any patents that the approval holder believes will cover the approved biologic, its use, or its manufacture. After receipt of such a request, the approval holder then has 60 days to provide such patent information to the requestor, and must update that patent information for two years from date of initial inquiry. Once an application for approval of the biosimilar has been submitted to the FDA, the biosimilar applicant may (but is not required to) notify the approval holder of the filing of the application. If such a notification is sent, it must include a patent notification similar to that for a paragraph IV certification under Hatch-Waxman, and the holder of the approval on the reference biologic would then have 45 days to sue the biosimilar applicant. Under the Eshoo bill, the FDA would provide a copy of a biosimilar application to the reference product approval holder, who would then be required to (a) provide the biosimilar applicant with a list of patents that purport to cover the product or its use, and (b) explain in writing to the biosimilar applicant why the reference product approval holder believes the biosimilar product would infringe one or more patents on that list. Thus, the Eshoo bill shifts the burden of patent certification from the biosimilar applicant to the reference product approval holder, a significant departure from both the Hatch-Waxman regime and that provided under the Waxman biosimilars bill.


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