On March 29, 2023, the Food and Drug Administration approved the first naloxone product available without a prescription. Naloxone is a medication that rapidly reverses the effects of and is the standard treatment for opioid overdose. Emergent BioSolutions anticipates its Narcan (naloxone hydrochloride) 4 mg nasal spray will be available for consumers to purchase over-the-counter by August 2023. Pricing information has not yet been released. Currently, prescription versions will remain available through pharmacies (via standing order or co-prescription laws) and other community distribution methods.
For more information visit: https://www.fda.gov/news-events/press-announcements/fda-approves-first-over-counter-naloxone-nasal-spray

Photo Credit: Giovanni Cancemi - http://stock.adobe.com

In March 2023, the U.S. Senate Committee on Homeland Security and Governmental Affairs released a document supporting findings that drug shortages increased by almost 30% between 2021 and 2022. The number of active drug shortages in the U.S. reached a peak of 295 at the end of 2022. In just the last 60 days, two generic manufacturers have left the generic drug market with Akorn Pharmaceuticals filing for Chapter 7 bankruptcy and Eagle Pharmaceuticals withdrawing its only generic product from the market. Furthermore, increases in telehealth services for attention-deficit/hyperactivity disorder (ADHD) have only expanded the shortage of products like immediate-release (IR) amphetamine mixed salts to methylphenidate. If this trend of generic manufacturers leaving the market continues, we could see less opportunity for discounts and increased future drug shortages, leading to an increase in usage of more costly brand name medications.

https://www.hsgac.senate.gov/wp-content/uploads/Drug-Shortages-HSGAC-Majority-Staff-Report-2023-03-22.pdf

Recently, the U.S. Centers for Disease Control and Prevention (CDC) released its updated recommendations to immunization schedules for children and adolescents 18 years of age or younger, and for adults 19 years of age or older. These schedules were previously approved by the Advisory Committee on Immunization Practices (ACIP) in October 2022. With this update, COVID-19 vaccinations were included as part of the routine immunization schedules for both children, adolescents, and adults; however, this does not mean COVID-19 vaccinations will be required by schools or workplaces. School-entry vaccination requirements are determined by state or local jurisdictions. For more information on CDC vaccination schedules, please visit: https://www.cdc.gov/vaccines/schedules/

On January 31st, Amgen introduced Amjevita™ (adalimumab) citrate-free injection, a biosimilar to Humira® (adalimumab) injection 50mg/mL. Amjevita™ is the first of several Humira® biosimilars to become available in the United States. Additional biosimilars, including some that will be classified as interchangeable with Humira®, are expected to launch in the second half of 2023. Amjevita™ is approved for treating most of the same inflammatory conditions as Humira®, with the exception of hidradenitis suppurativa and uveitis. ProAct is currently conducting a value assessment and will be adding it to our formulary within the next 60 days. Amjevita™ is available at our specialty pharmacy, Noble Health Services.

Beginning next month and continuing throughout 2023, it is expected that 14 or more biosimilar versions of AbbVie’s Humira (adalimumab) will be launched to market, marking the largest loss-of-exclusivity event in the history of pharmaceuticals. As of December 13, 2022, eight biosimilars have been approved by the Food and Drug Administration. Although pricing information will likely not be available until closer to each product’s launch date, we expect that some biosimilars for Humira will be placed on ProAct’s preferred brand drug list.