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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