FDA Pipeline preview, August 2008

Steqeyma is one of seven Stelara biosimilars that have been approved by the FDA.

Lumicera Health Services, Navitus’ specialty pharmacy, has made a deal with Teva to offer an unbranded biosimilar that they estimate will save $112,000 and $336,000 per patient per year. Navitus will remove Stelara from formulary on July 1, 2025.

The new bill would also require state Medicaid programs to report National Average Drug Acquisition Costs (NADAC) as a way to increase transparency in drug pricing.

Two companies have received approved for a generic of the 2.5 mg tablet of anticoagulant rivaroxaban, which is used to reduce the risk of stroke and deep vein thrombosis.

Celltrion’s Omlyclo is interchangeable with Xolair to treat the same conditions: asthma, chronic rhinosinusitis, food allergy and chronic spontaneous urticaria.

Neffy 1 mg is now approved by the FDA to treat pediatric patients who weigh 33 to 65 lbs. Neffy was first FDA-approved as a 2 mg dose in August 2024 for the emergency treatment of anaphylaxis in children and adults weighing at least 66 lbs.