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UPDATE: Biosimilars to Humira to Launch in January 2023

UPDATE: Biosimilars to Humira to Launch in January 2023 hero image

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.

DRUG MANUFACTURER DATE APPROVED EXPECTED LAUNCH DATE

Amjevita

Amgen

09/23/2016

01/31/2023

Abrilada

Pfizer

11/15/2019

07/01/2023

Cyltezo

Boehringer Ingelheim

08/25/2017

07/01/2023

Hadlima

Samsung Bioepis/Organon

07/23/2019

07/01/2023

Idacio Fresenius Kabi 12/13/2022 07/01/2023

Yusimry

Coherus

12/17/2021

07/01/2023

Hulio

Viatris/Biocon

07/06/2020

As early as 07/2023

Hyrimoz

Novartis

10/30/2018

As early as 07/2023

 

First Gene Therapy Approved for Bladder Cancer

First Gene Therapy Approved for Bladder Cancer hero image

On December 16, 2022, the Food and Drug Administration granted approval to Adstiladrin, the first gene therapy indicated for the treatment of adult patients with a specific form of unresponsive non-muscle-invasive bladder cancer (NMIBC). According to the manufacturer, Ferring, the gene therapy should be available in the second half of 2023. Although pricing information for Adstiladrin has not yet been announced, it is expected to have an estimated cost of $181,000 annually and compete with Keytruda.
 
https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-treatment-high-risk-non-muscle-invasive-bladder-cancer

Continuous Glucose Monitoring Devices

Continuous Glucose Monitoring Devices hero image

Continuous Glucose Monitoring (CGM) systems offer either real-time monitoring of blood glucose levels (Dexcom G6®, Freestyle Libre 3®, Guardian Connect®, Eversense E3®) or intermittent scanned monitoring, often referred to as a flash CGM (Freestyle Libre 2® and Libre 14 Day® devices). We are beginning to see coverage of CGM devices migrate toward the pharmacy benefit instead of only the medical benefit. This is an effort to improve patient access and corresponds with the transition of tubeless insulin pump products that integrate with CGM devices to the pharmacy benefit. The Centers for Medicare & Medicaid Services (CMS) continue to cover CGM devices under the medical benefit Part B. There are four major manufacturers of CGM devices: Abbott Laboratories (FreeStyle®), Dexcom (Dexcom G6®), Medtronic (Guardian Connect®), and Ascensia Diabetes Care (Eversense E3®). Depending on the product and type of technology, the wholesale acquisition cost can range from as little as $122 per month up to approximately $700 per month for the device components.

https://www.diabeteseducator.org/docs/default-source/practice/educator-tools/role_cgm_12272021.pdf

New Gene Therapy Approval

New Gene Therapy Approval hero image

On November 22, 2022, the FDA approved CSL Behring’s Hemgenix, a gene therapy for treatment of adults with hemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes. Although hemophilia B is a rare condition, intravenous infusions to treat hemophilia B range from $550,000-$750,000 annually. Hemgenix is administered as a single dose intravenous infusion. Hemgenix will cost approximately $3.5 million, which will make it the most expensive medicine approved to date in the world for a single-use therapy.

https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-treat-adults-hemophilia-b

Considerations for Insulin Product Substitutions

Considerations for Insulin Product Substitutions hero image

Insulin is a standard of care for the treatment of diabetes and accounts for a large amount of sales in the diabetic drug therapy space. There is often confusion on when an insulin product can be substituted by a pharmacist. Unbranded insulin products are packaged and marketed without a brand-name under the same Biologics License Application as the brand-name product and are considered equivalent and interchangeable. This includes Novolog®/ Insulin Aspart (unbranded), Humalog®/ Insulin Lispro (unbranded), and Semglee (yfgn)®/Insulin Glargine (yfgn) (unbranded). …

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