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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).

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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...

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Joanna Hawana, Mintz Levin, FDA Lawyer, Clinical Trials & Research Consumer Product Safety FDA Regulatory Health Care Compliance, Fraud & Abuse, and Regulatory Counseling Health Care Transactional Due Diligence
Of Counsel

Joanne counsels global clients on regulatory and distribution-related considerations to bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized. She also advises on the business impact of new US federal and state actions that affect those regulated products, such as drugs, foods, cosmetics, electronic nicotine delivery systems, and medical devices, including in vitro diagnostics, lab tests, and mobile medical applications. In recent years she has been advising clients in different industries regarding FDA’s approaches to precision medicine and the impact of the agency’s policies on product development and marketing plans.  

Her strategic counseling and compliance support work reaches into all aspects of FDA-regulated companies’ operations, including:

  • Determining regulatory status of novel products like mobile health systems and point-of-care diagnostics;
  • Pre-market and post-market requirements for various regulated products;
  • Restrictions on advertising and sampling, including for controlled substances;
  • State licensing schemes for prescription drug manufacturers and distributors;
  • Federal track-and-trace obligations for all members of the prescription drug supply chain, from manufacturers to pharmacies;
  • Compliance with drug compounding regulations, both State and Federal;
  • Review and approval of various types of policies and procedures for facilities that manufacture or distribute regulated products;
  • Advising on clients’ written submissions to FDA requests for comments or rulemaking activities, and in some cases preparing those submissions on behalf of private companies or patient advocacy groups;
  • Requirements for importing and exporting regulated products; and
  • Food safety and labeling advice for human and animal food, including dietary supplements and “functional foods,” as well as alcoholic beverage products.

Joanne frequently works with clients to develop and implement their responses to common FDA actions, such as warning letters and inspectional reports (the “Form 483”). She has also been involved in advising and helping clients respond to Federal Trade Commission investigations related to product advertising and requests for substantiation of certain promotional claims.

Joanne also assists the Mintz corporate team by performing regulatory due diligence as part of potential mergers and acquisitions that involve regulated companies, and she often works in conjunction with the Firm’s intellectual property attorneys to ensure that patent and regulatory activities are strategically aligned.  She has developed a distinctive relationship with Mintz attorneys who negotiate royalty monetization transactions and works closely with them in developing the terms for these unique transactions. Although the day-to-day work for clients may be different, the common thread that she enjoys most is helping companies (both start-up and established) bring their products to market – without heightened risks of enforcement actions as a result of non-compliance with sometimes-opaque regulatory requirements.

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