By Kurt R. Karst –
We present to you the Biosimilars State Legislation Scorecard. Links are provided to each piece of legislation. We also give you a word or two on status. In most cases, a summary of each bill is provided at the linked-to website. In general, legislation introduced follows the principles advocated for by organizations such as the Biotechnology Industry Organization – specifically: (1) substitution should occur only when the FDA has designated a biologic product as interchangeable; (2) the prescribing physician should be able to prevent substitution; (3) the prescribing physician should be notified of the substitution; (4) the patient, or the patient’s authorized representative, should, at a minimum, be notified of the substitution; and (5) the pharmacist and the physician should keep records of the substitution.
Biosimilars State Legislation Scorecard
- Five states (Florida, North Dakota, Oregon, Utah, and Virginia) have enacted laws specifying the circumstances under which pharmacists could substitute biosimilars for reference products. Three of the laws (Oregon, Utah, and Virginia) include a sunset date.
- Legislation has failed to pass in eleven states (Arizona, Arkansas, California, Colorado, Delaware, Illinois, Indiana, Maryland, Mississippi, Texas, and Washington).
- Two states (Arkansas and Indiana) have referred biosimilar legislation to a study committee for further review.
- Legislation is pending in ttwo states (Massachusetts, and Pennsylvania)
- S.B. 1438 (2013) – Died on Adjournment
- S.B. 149 (2013) – Died on Adjournment (Recommended for study in the Interim Committee on Senate Committee on Public Health, Welfare and Labor)
- S.B. 386 (2013) – Died on Adjournment
- S.B. 598 (2013-2014) – Passed Senate and Assembly; Vetoed by Governor (see here)
- A.B. 1139 (2013-2014) – In Committee
- H.B. 1121 (2013) – Senate Committee on Health & Human Services Postpone Indefinitely (effectively dead)
- S.B. 118 (2013) – Died on Adjournment
- H.B. 365 (2013) – Enacted; Chapter No. 2013-102
- S.B. 732 (2013) – Laid on Table; Companion bill passed (H.B. 365)
- S.B. 1934 (2013) – Referred to Assignments (effectively dead)
- S.B. 272 (2013) – Died on Adjournment
- H.B. 1315 (2013) – Enacted without biosimilar provisions
- Senate Resolution 112 (2013) – Adopted voice vote
- S.B. 781 (2013) – Died on Adjournment
- H.B. 1927 (2013) – Pending; Joint Public Health Committee
- The Generic Pharmaceutical Association has identified Nevada as a state in which legislation was “killed”; however, we are not aware of any legislation introduced.
New Hampshire (None)
New Jersey (None)
New Mexico (None)
New York (None)
North Carolina (None)
- S.B. 2190 (2013) – Enacted; Chapter 19-02.1
- S.B. 405 (2013-2014) – Pending; Senate Public Health & Welfare Committee
- H.B. 746 (2013-2014) – Pending; House Health Committee
Rhode Island (None)
South Carolina (None)
South Dakota (None)
- S.B. 78 (2013) – Enacted
West Virginia (None)
This post, originally posted to the FDA Law Blog on September 4, 2013, opened as follows:
With the news last week that the Assembly in the bellwether state of California passed a bill – S.B. 598 – concerning the substitution of biosimilar and interchangeable biosimilar products for their brand-name reference product counterparts, and with bills currently passed, failed or pending in other states (and the likelihood that legislation will continue to be pushed in several states for some time to come), we thought it was high time to put together a new scorecard – the Biosimilars State Legislation Scorecard – to keep tabs on such legislation. Once we get a chance, we’ll add a direct link to this new scorecard, along with any others we have created (such as our popular Generic Drug Labeling Carve-Out Citizen Petition Scorecard) to the FDA Law Blog website where our various trackers (Citizen Petition Tracker, Legislation Tracker, 180-Day Exclusivity Tracker, and REMS Tracker) are linked to as well. We’ll update the scorecards periodically and post separately on items that are particularly newsworthy.
(UPDATE: On September 4th, the California Senate voted to pass S.B. 598 – see here. The Generic Pharmaceutical Association subsequently issued a press release – as well as a bunch of additional materials – urging Governor Jerry Brown to veto S.B. 598.)
State legislation addressing biosimilar substitution issues has been particularly controversial (see our previous post here). Indeed, after the California Assembly’s passage of S.B. 598, an FDA spokesperson reiterated concerns previously expressed by FDA Commissioner Margaret Hamburg that “[e]fforts to undermine trust in these products are worrisome and represent a disservice to patients who could benefit from these lower-cost treatments.”
Others might say that state legislative efforts to address substitution are premature. After all, FDA has not yet even approved (let alone filed) a Section 351(k) biosimilar application submitted pursuant to the procedures established by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) and discussed in draft FDA guidance (see our previous post here). Then there’s that April 2012 citizen petition (Docket No. FDA-2012-P-0317) submitted by Abbott Laboratories requesting that FDA not accept for filing, file, approve, or even discuss with any company any application or any investigational new drug application for any biosimilar that cites as its reference product any product for which the BLA was submitted to FDA prior to the date on which the BPCIA was enacted (see our previous post here). FDA has not yet substantively responded to the petition; however, query whether FDA’s meetings with biosimilar sponsors (see the next paragraph), if they concern pre-BPCIA products, is a constructive denial of the petition (at least in part). (And, as an aside, there’s ongoing debate about including a 12-year period of exclusivity for biological products in the Trans-Pacific Partnership agreement chapter on intellectual property rights – see our previous posts here, here, here and here, and a recent letter and paper from the Biotechnology Industry Organization here and here.)
Despite efforts that some have alleged are intended to stymie the nascent biosimilars industry, interest in developing biosimilars remains high. According to one report, FDA “continues to meet with sponsors interested in developing biosimilar products,” and as of the last week of August 2013, the Agency “had received 57 meeting requests for an initial meeting to discuss biosimilar development programs for 13 different reference products and held 47 initial meetings with sponsors.”