RxAdvocate October, 2023 — Newsletter

The FDA recently approved two new biosimilars. Tofidence, a biosimilar for Actemra and Tyruko, a biosimilar for Tysabri, are both the first biosimilars to be approved for their respective reference products. Actemra is an IL-6 receptor antagonist that is approved for use in adult rheumatoid arthritis, plus systemic and polyarticular juvenile idiopathic arthritis and reported $1.2 billion in US sales for 2022. Tysabri, with $2 billion in 2022 US sales, is indicated for use in relapsing forms of multiple sclerosis and moderate to severe active Crohn’s disease.

These new biosimilar approvals, paired with the influx of Humira biosimilars to the market earlier this year, will continue to drive down future plan spend for high-cost specialty medications.

Each year, an estimated 58,000-80,000 children under 5 years old and approximately 60,000-160,000 older adults are hospitalized due to RSV. In May 2023, the FDA approved Arexvy and Abrysvo for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 60 years of age and older. In August 2023, Abrysvo was also FDA approved to be administered to pregnant individuals late in their pregnancies to provide RSV protection to infants through their first 6 months of life. Beyfortus, approved in July 2023, is for the prevention of RSV in newborns and infants born during or entering their first RSV season and for children up to 24 months of age.