June 24, 2017

June 23, 2017

Subscribe to Latest Legal News and Analysis

June 22, 2017

Subscribe to Latest Legal News and Analysis

New State Substitution Laws, and a Busy Spring for Biosimilars

We recently updated our chart that tracks state biosimilar substitution laws to include new laws in Iowa and Montana. These new laws bring the total number of states with biosimilar substitution laws to 27, plus Puerto Rico. The latest version of our chart can be dowloaded here. As with the laws we’ve seen before, both the Iowa and Montana biosimilar amendments mirror the state’s existing generic drug substitution laws. More specifically, they amend state pharmacy laws to allow, and in some situations require, the substitution of interchangeable biosimilars.

Iowa Substitution Law Is a Bit Different, but Fundamental Challenges Remain

Interestingly, the Iowa law is the first law we’ve seen to make a distinction between Medicaid and non-Medicaid patients for purposes of a biosimilar substitution.  The law requires pharmacists to substitute an interchangeable biosimilar for Medicaid patients, but provides pharmacists with discretion for non-Medicaid patients. It also only allows non-Medicaid patients to request the prescribed biological product to be dispensed instead of the substitution. Notwithstanding its novelty compared to other states, the amendment isn’t completely unexpected because Iowa’s pharmacy laws contain similar provisions for the substitution of generic drugs. Moreover, most, if not all, state Medicaid laws and regulations require generic substitution for drugs, so we expect that Medicaid programs will also require the substitution of interchangeable biosimilars as they enter the market and more patients begin using them.

It is also important to note that none of the state biosimilar substitution laws currently on the books will have a direct effect on available FDA-approved biosimilars. Although FDA has approved four biosimilars as of mid-April 2017, all of them are physician-administered, rather than dispensed from a retail pharmacy and administered by a patient. States have continued to model biosimilar substitution laws on generic drug substitution laws, despite the fact that biosimilars are less likely to be dispensed at a retail pharmacy. These laws do not impact the behavior of physicians who administer biosimilars, and do not impose the same requirements for patient knowledge or consent when physicians choose to substitute a biosimilar. Another potential trend we will be watching for is whether state medical boards begin providing guidance to licensed physicians on this type of interaction with patients.

Finally, none of the FDA-approved biosimilars have yet applied for or received the status of interchangeability.  In January 2017, FDA issued the long-awaited draft guidance on its expectations for biosimilar applicants who wish to demonstrate interchangeability, and it recently extended the comment period for this guidance until May 19, 2017, in response to requests for more time from industry stakeholders.

Upcoming Biosimilar Milestones for Spring 2017

The next few months of 2017 are also likely to be critical for the emerging biosimilar marketplace for several reasons.  First, on April 26, 2017, the Supreme Court will hear oral arguments in the first biosimilar-related litigation to reach that highest court, Sandoz v. Amgen.  This is an appeal from a July 2016 Federal Circuit ruling that, among other things, held the 180-day notice of commercial marketing can only be provided to the Reference Product Sponsor after FDA licensure of the biosimilar (see our previous coverage here).  The Court will be expected to render a decision in the case by the end of its current session in June.  Stay tuned for further coverage of the case!

In addition, FDA announced this week that it is convening a meeting of its Oncologic Drugs Advisory Committee on May 25, 2017, to consider Hospira’s pending abbreviated BLA 125545 for a proposed biosimilar to Amgenʼs Epogen/Procrit (epoetin alfa), tentatively named “Retacrit.”  It has been the Agency’s policy to bring the first biosimilar of each reference product to a committee of outside experts for their review and feedback before it licenses the aBLA.  If last year’s advisory committee and FDA approval decision timeline for new biosimilar applications is any indication, we should see a final decision on the Retacrit aBLA by the end of June or July this year – paving the way for the first epoetin alfa biosimilar to launch in the U.S. (assuming any pending litigation is resolved, of course).

©1994-2017 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

TRENDING LEGAL ANALYSIS


About this Author

Sarah Beth S. Kuyers, Mintz Levin, nonprofit affiliation lawyer, health care systems attorney
Associate

Sarah Beth’s practice focuses on advising health care providers, PBMs, and laboratories on a variety of regulatory issues.

Prior to joining Mintz Levin, Sarah Beth worked as a law clerk with the health staff of the US Senate Committee on Finance, where she researched policy, regulations, and legislation regarding commercial insurance reform, health IT, Medicare, Medicaid, and the Affordable Care Act. She also drafted legislation.

In addition, Sarah Beth worked as a law clerk for a legal practice in Washington, DC. Her...

202.434.7453
Joanna Hawana, Mintz Levin, FDA Lawyer, Consumer Protection Attorney, Washington
Of Counsel

Joanne advises clients around the world in the food, drug, and biotechnology industries on issues ranging from prescription drug advertising to state licensing requirements for wholesale distribution. In particular, Joanne counsels clients on the business impact of new US federal and state actions that affect regulated products, such as drugs, foods, and medical devices.

Joanne is experienced in US federal drug regulations, including pre-market and post-market requirements, and restrictions on advertising and sampling. Joanne also has counseled clients on state regulation of prescription drug distribution and licensing requirements. She is well versed in advising clients on the regulatory considerations for marketing controlled substances, track-and-trace systems for prescription drugs, and the food safety and labeling requirements for human and animal food. Joanne also has counseled both pharmacies and practitioners on drug compounding regulatory matters.  In addition, she has worked with manufacturers and retailers to determine the regulatory status of certain medical devices, laboratory tests, and mobile medical applications.

202.434.7349