May 24, 2022

Volume XII, Number 144


May 23, 2022

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Biosimilar Developments Continue at a Rapid Pace

As our regular readers know, we’ve been tracking regulatory approvals, reimbursement policies, pharmacy substitution laws, and other developments related to biosimilar biological products. Biosimilars rely on the safety and efficacy history of an existing biological product for FDA approval by demonstrating that the biosimilar is “highly similar” to the reference product.  Recent weeks have been busy ones for state and federal officials involved in this area, and certainly the same can be said for developers of biosimilar products who need to keep pace with these rapid developments.

State Substitution Laws

As the 2016 State Legislative Session enters full swing (indeed, a few regular sessions have already adjourned for the year), we expect that more states will join Puerto Rico and the nearly 20 states that have enacted new laws or regulations specific to biosimilar substitution and dispensing as of the end of last year.  According to a recent tally by the National Conference of State Legislatures, at least 10 bills related to biosimilars (either newly filed or carried over from 2015) are pending this spring, many of which are very similar to laws already in effect in other states.

We are reporting that the “pending bills” number is 10 rather than 11, as the NCSL currently indicates, because the Kentucky legislature has joined several of its neighbors (Illinois, Indiana, Tennessee, and Virginia) in overwhelmingly approving an automatic biosimilar substitution law.  On March 29th, the bill was delivered to the Governor for signing, which he is expected to do.  Like many other biosimilar-specific laws, Kentucky’s new S.B. 134 requires dispensing pharmacists to notify the prescribing physician of any substitution within 5 days, preferably through an electronic medical records system or other technology accessible to the prescriber.  The bill also requires pharmacists to substitute a lower cost interchangeable biosimilar for the prescribed product, absent any instruction otherwise from the patient or physician.  This contrasts with several other substitution laws we’ve seen that permit the pharmacist to make an automatic substitution, instead of requiring the pharmacist to do so.

Our State Biosimilar Substitution Laws Chart has been updated to reflect this development in Kentucky as well as the passage of laws in New Jersey and Puerto Rico late last year.

FDA Continuing Education Course for Health Care Providers

In addition, as we previously reported, a second biosimilar application (authorizing the marketing of the first biosimilar monoclonal antibody product) is expected to be approved by FDA in the near future, likely before the end of April.  As more of these products enter the U.S. market, concerns about their acceptance by health care providers and patients are becoming more acute.  Recognizing the fact that these follow-on biologics and their regulatory approval pathway are unique in myriad ways, FDA recently launched a free online Continuing Education course for health care professionals (available here).  The course covers how biosimilars are reviewed and approved by the Agency, as well as the differences between biosimilars and small-molecular generic drugs.  In an “FDAVoice” blog post announcing availability of the CE course, senior agency official Dr. Leah Christl added that it “also will help health care professionals understand how a biosimilar can be prescribed and dispensed, and how and when an interchangeable product can be substituted for another biological product.”

©1994-2022 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.National Law Review, Volume VI, Number 92

About this Author

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...