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ProAct
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FDA Approves First Stelara Biosimilar

FDA Approves First Stelara Biosimilar hero image

On October 31, 2023, the U.S. Food and Drug Administration (FDA) approved Wezlana™ (ustekinumab-auub) injection manufactured by Amgen. This is the first approved biosimilar to Stelara®  (ustekinumab) injection manufactured by Janssen Biotech – Wezlana™ is also interchangeable. In states where pharmacy regulations allow substitution, it can be dispensed instead of Stelara® without contacting the prescriber. Ustekinumab is used to treat adults who have active Crohn’s disease (CD) or ulcerative colitis (UC), psoriatic arthritis (PsA) or plaque psoriasis. Under a settlement agreement, Wezlana™ can be launched in the U.S. at any time before January 1, 2025. Additional biosimilars to Stelara® are expected to launch in 2025. U.S. sales for Stelara® amounted to approximately $6.4 billion in 2022.

https://www.fda.gov/news-events/press-announcements/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases

ProAct's Insulin Price and Formulary Strategy

ProAct's Insulin Price and Formulary Strategy hero image

On March 14, 2023, Novo Nordisk announced price cuts to several prefilled insulin pens and vials, which will be effective starting on January 1, 2024. Outlined below…

FDA Approves Launches of Vyvanse Generic

FDA Approves Launches of Vyvanse Generic hero image

On August 25, 2023, several generic drug manufacturers received U.S. Food and Drug Administration (FDA) approval for A-rated generics to Vyvanse® (lisdexamfetamine – Takeda Pharmaceuticals). Lisdexamfetamine is taken once each morning to treat attention deficit hyperactivity disorder (ADHD) for patients at least six years old and binge eating disorder (BED) for adults. A boxed warning cautions that lisdexamfetamine is a Class II controlled (CII) central nervous system (CNS) stimulant with increased potential for abuse and/or dependence. Brand Vyvanse® typically costs about $370 per month while generic lisdexamfetamine is expected to cost approximately $160 per month.

https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-multiple-generics-adhd-and-bed-treatment

Monitoring the Growth of the Obesity Medication Pipeline

Monitoring the Growth of the Obesity Medication Pipeline hero image

The increased awareness and discussion around more effective weight management medications has resulted in obesity medication pipeline growth. Research and development is focusing on new dosage forms, oral versus injectable, and combinations with glucagon-like peptide-1 receptor agonists.  Currently, Eli Lilly and Company (Lilly) and Novo Nordisk dominate the pipeline for weight management medications.

Product Manufacturer Route Frequency Class Maximum Average Weight Loss (Timeframe) Expected Approval
tirzepatide Lilly SC Once weekly GLP-1 receptor agonist 13.4%
(72 weeks)
Late 2023 -
Early 2024
semaglutide Novo Nordisk Oral Once daily GLP-1 receptor agonist 15.1%
(68 weeks)

2024

CagriSema (cagrilintide/semaglutide) Novo Nordisk SC Once weekly Amylin analog/GLP-1 receptor agonist 15.6%
(32 weeks)
2025
danuglipron Pfizer Oral Twice daily GLP-1 receptor agonist -5.4kg
(12 weeks)
2025
retatrutide Lilly SC Once weekly GIP/GLP-1/Glucagon receptor agonist

17.5%
(24 weeks)

24.2%
(28 weeks)

2026+
orforglipron Lilly Oral Once daily GLP-1 receptor agonist 14.7%
(36 weeks)
2026+

 

Reference source: https://www.clinicaltrialsarena.com/features/obesity-trials-to-watch/

First Generic of Symbicort Launched

First Generic of Symbicort Launched hero image

On July 31, 2023, Viatris and Kindeva launched Breyna™, an AB-rated generic version of AstraZeneca’s Symbicort® (budesonide/formoterol) metered-dose inhaler. This generic medication was approved by the FDA on March 15, 2022 and is used in the treatment of asthma and chronic obstructive pulmonary disease (COPD). Breyna’s™ wholesale acquisition cost (WAC) is approximately a 39% discount off Symbicort®. ProAct will work with our members taking Symbicort® to transition from the brand name medication to the lower cost generic alternative. 

https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-symbicort-treat-asthma-and-copd

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