FDA Approves First Rapid-Acting Insulin Biosimilar: MerilogTM (insulin aspart-szjj)
On February 14, 2025, the FDA approved the first rapid-acting insulin biosimilar, MerilogTM (insulin aspart-szjj) manufactured by Sanofi Aventis. MerilogTM is expected to reach the U.S. market in July 2025 and will require prescriber approval before pharmacies can substitute for other insulin aspart products such as Fiasp® or NovoLog®.
MerilogTM is the third insulin biosimilar approved by FDA (along with RezvoglarTM and Semglee®).
PAAS Tips:
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- Review the November 2024 article, Understanding Biologic Substitutions – New Tool Available! for a refresher on terms used to describe biologic products such as reference product, biosimilar, and interchangeable
- Remember to document prescriber approvals for substitution with a clinical note on the prescription or in your pharmacy software
Analyst at PAAS National®
As an Analyst, I focus on providing pre- and post-audit assistance, answering various member service questions, and researching & drafting articles for the Third-Party Newsline. I work with many of our members involved with invoice audits.
I obtained my PharmD from the University of Wisconsin-Madison School of Pharmacy and worked for a major chain as well as various LTC and independent pharmacies, before coming to PAAS.
I am passionate about learning and teaching. I strive to learn something new about PBM audits every day, so that PAAS can be more knowledgeable to better serve our members! In 2018, I started traveling to state pharmacy conferences to present audit seminars and meet our wonderful members in person.
I obtained my PharmD from the University of Wisconsin-Madison School of Pharmacy and worked for a major chain as well as various LTC and independent pharmacies, before coming to PAAS.
I am passionate about learning and teaching. I strive to learn something new about PBM audits every day, so that PAAS can be more knowledgeable to better serve our members! In 2018, I started traveling to state pharmacy conferences to present audit seminars and meet our wonderful members in person.
Latest posts by Eric Hartkopf, PharmD (see all)
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