RxAdvocate May, 2024 — Newsletter

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May 5 RxAdvocate May, 2024 — Newsletter

Posted at 13:51h in Newsletter by
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May Stories:

  • FTC Crackdown on “Junk” Patent Listings Including Ozempic
  • FDA Approves First Two Stelara Biosimilars
  • The Best Protection Against Measles
  • Mother’s Day

FTC Crackdown on “Junk” Patent Listings Including Ozempic

The U.S. Federal Trade Commission (FTC) is cracking down on what it views as improper listing of patents with the Federal Drug Administration (FDA).

 

The FTC has identified patents for 20 brand-name products including Novo Nordisk’s Ozempic, Saxenda and Victoza, as “junk” listings that could be used by pharma companies to hinder competition and inflate drug prices. The FTC argues that by initiating sham patents, pharmaceutical companies have exploited a policy that blocks the FDA from approving generic versions of the originator product.

 

FDA Approves First Two Stelara Biosimilars

Stelara (Ustekinumab), used to treat adults who have active Crohn’s disease or ulcerative colitis, psoriatic arthritis, or plaque psoriasis, now has two biosimilars that have been approved by the FDA.

 

The first Stelara biosimilar approval came on October 31, 2023, with the approval of Wezlana (ustekinumab-auub), an interchangeable biosimilar. This means in states where pharmacy regulations allow substitution, it can be dispensed instead of Stelara without contacting the prescriber.

Most recently, the second Stelara biosimilar, Selarsdi (ustekinumab-aekn) was approved on April 16, 2024. Both products are expected to launch in 2025 under settlement agreements, with Wezlana manufacturers stating it should launch by January 1, 2025, and Selarsdi manufacturers stating their product would launch on or after February 21, 2025. U.S. sales for Stelara amounted to approximately $6.4 billion in 2022.

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The Best Protection Against Measles

Vaccination is the best protection against Measles. Measles is caused by a virus through the air when an infected person coughs or sneezes. It is considered one of the most contagious respiratory diseases that can also potentially be life-threatening. Safe and effective vaccines are approved by the U.S Food and Drug Administration for the prevention of Measles. Most people who get the recommended doses of a vaccine have a lifelong protection in the prevention of Measles.

 

Measles tend to strike children but can infect all age groups. Children under the age of 5 years old and adults over the age of 20 years old are more likely to experience measles complications. Vaccines not only assist to prevent measles, but they can also protect children and other people who can’t be vaccinated including young infants or people with weakened immune systems.

The FDA plays an important role ensuring the safety and effectiveness of all approved vaccines for use in the United States, including those that prevent Measles.

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Happy Mother’s Day

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