Eshoo Amendment Would Allow Substitution Of Biosimilars Without Health Care Provider Okay

Few differences with Senate HELP bill remain, as House Democrat adopts that panel's language on products available for data exclusivity.

Language that is more supportive of substituting biosimilars for their reference products has been added to a follow-on biologics amendment that Rep. Anna Eshoo, D-Calif., will propose when the House Energy and Commerce Committee resumes markup of health care reform.

A new definition of "interchangeable" and "interchangeability" says that a biosimilar approved as interchangeable "may be substituted for the reference product without intervention of the health care provider who prescribed the reference product."

While the language would give federal support for substitution, the "may" is not a "shall" or even a "should," so the decision ultimately will rest with the states under their dispensing laws. Eshoo's original H.R. 1548 specifically protected states' rights, saying that "nothing in this subsection shall be construed as preempting or otherwise affecting the authority of a state to require or regulate prescriptions."

The revised substitutability provision was taken from the biosimilars approval pathway proposed by Republican Sens. Orrin Hatch of Utah, and Mike Enzi of Wyoming, and North Carolina Democrat Kay Hagan and approved by the Senate Health, Education, Labor and Pensions Committee (Also see "Follow-on Biologics Go Back To The Future: Senate Cmte. Endorses 12 Years of Brand Exclusivity" - Pink Sheet, 13 Jul, 2009.).

As a practical matter, the impact of the modification is questionable, since most experts do not expect that substitutable biosimilars can be readily developed in the near term.

Eshoo has been rewriting the approval pathway in H.R. 1548 to minimize differences with the HELP version . This includes adopting language in the data exclusivity section that would prevent reference product sponsors from receiving exclusivity for structural modifications to existing biologics that do not result in a change in safety, purity or potency.

Some Differences Remain

The few remaining differences include an Eshoo requirement that a biosimilar have a unique name that distinguishes it from the reference product and other biosimilars; six months of data exclusivity for appropriate pediatric studies; and restrictions on biosimilars containing toxins or controlled substances.

The Eshoo amendment would fund FDA review of follow-on biologics by adding biosimilars to the existing drug user fee program. The HELP bill authorizes a new user fee program. While structurally, the Eshoo approach seems simpler, it could result in higher fees for follow-on products since they could be subject to the same fees as a full BLA.

Eshoo also has dropped sections to amend the U.S. Patent Act and limit actions for declaratory judgments.

Should the biosimilars pathway in the Senate HELP bill survive floor debate, and Eshoo's proposal make it through markup against Committee Chairman Henry Waxman's competing proposal and subsequent floor action, the similarity in the two pathways would offer little opportunity for changes during conference committee. The need would be to align the patent provision.

Negotiations with conservative Democrats over their concerns about funding health care reform in H.R. 3200 have delayed markup of the bill. But committee sources indicate progress is being made and the panel may reconvene July 23 for further action.

- Cathy Dombrowski ([email protected] )