June 6 RxAdvocate June, 2023 — Newsletter
June Stories:
- FDA approves Rinvoq for Crohn’s Disease
- Humira Biosimilars
- Congenital Heart Disease
- Community Involvement
On May 18, 2023, the FDA approved Rinvoq as a once daily oral treatment option for adults with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.
This is the 7th FDA approval for Rinvoq across several disease states including rheumatology, dermatology, and gastroenterology, where it is now indicated for both ulcerative colitis and Crohn’s disease. Crohn’s disease is a chronic inflammatory bowel disease that causes inflammation in the digestive tract. It is a progressive disease state, meaning it gets worse over time, and generally leads to surgery. The most common symptoms include diarrhea, cramping, stomach pain, and weight loss.
The Food and Drug Administration defines a biosimilar as a “biologic product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product.” Humira (adalimumab), an anti-inflammatory drug approved to treat various conditions including rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis and Crohn’s disease, is expected to have several biosimilars enter the market this year.
The first adalimumab biosimilar, Amjevita, hit the market in January 2023 however by July 31, 2023, Amjevita will be joined by at least 6 more biosimilars including Cyltezo (the first interchangeable adalimumab biosimilar), Hyrimoz and Yusimry. However, these approvals do not mean prescriptions will immediately follow. There are factors to consider such as the contractual agreements between pharmacy benefit managers, payers and manufacturers that will determine which, if any, biosimilars get placed on formularies and whether they are given preferred status.
Manufacturer pricing strategies in addition to provider uptake of utilization of adalimumab biosimilars will be key in increasing competition between the variety of biosimilars available and the reference product Humira. Click here to read more.
Congenital Heart Disease Awareness
RxConnection’s Strategic Account Executive, Christina Hollis, is participating in The Children’s Heart Foundation Heart Walk in September 2023 to raise awareness of congenital heart disease (CHD), which impacts 1 in every 110 babies.
Her 5-year-old daughter, Greta, was diagnosed with Hypoplastic Left Heart Syndrome (HLHS) 1 week before she was born, and has had 3 successful open-heart surgeries – most recently, the Fontan in May, 2022.
Click here to learn more about congenital heart disease and how you can help raise awareness.
Happy Father’s Day!
RxConnection sends our warm wished on this joyful Father’s Day to all fathers and their families.
Contact us
Orlando.Neal@rxconnectionllc.com