Another Interchangeable Lantus Biosimilar Approved
On April 29, 2026, the US Food and Drug Administration (FDA) approved a new interchangeable biosimilar to Sanofi’s Lantus® (insulin glargine) called Langlara™ (insulin glargine-aldy – Sunshine Lake Pharma/Lanexa Biologics) for the treatment of adults and pediatric patients who have type 1 diabetes mellitus and adults with type 2 diabetes mellitus. The FDA determined Langlara to be interchangeable with Lantus, which allows pharmacy‑level substitution without prescriber intervention in states that allow such practices. Approval was supported by comparable pharmacokinetics/pharmacodynamics, efficacy, safety, and immunogenicity to the reference product in patients with type 1 and type 2 diabetes. Full prescribing information is available here.
Jakafi XR Extended-Release Formulation Approved
The FDA approved Incyte’s Jakafi XR™ (ruxolitinib) extended‑release tablets for the treatment of adults with intermediate‑ or high‑risk myelofibrosis (MF), adults who have polycythemia vera (PV) with an inadequate response to or intolerance of hydroxyurea and adults and pediatric patients aged 12 years and older who have steroid‑refractory acute or chronic graft‑versus‑host disease (GVHD) after failure of one or two lines of systemic therapy on May 1, 2026. Jakafi XR is a once‑daily, film‑coated extended‑release formulation designed to provide consistent, day‑long exposure comparable to twice‑daily immediate‑release Jakafi. Approval was supported by a clinical study demonstrating that a single 55‑mg Jakafi XR tablet administered once daily was bioequivalent to a 25‑mg immediate‑release Jakafi tablet administered twice daily. It will be available in 11mg, 22mg, 33mg, 44mg, and 55mg tablets. Jakafi XR is expected to be available for pharmacy ordering starting May 8, 2026. The prescribing information is here.
FDA Grants Pediatric Indication Expansion to Asceniv
ADMA Biologic’s Asceniv™ (immune globulin intravenous [human]–slra 10% liquid) was granted an expanded indication for the treatment of primary humoral immunodeficiency (PI) to include pediatric patients two years of age and older on May 4, 2026. A plasma‑derived, intravenous immune globulin (IVIG) therapy, Asceniv is designed to provide passive immunity by supplying functional antibodies to patients with impaired antibody production. It was previously approved for PI patients aged 12 years and older; therefore, the expanded label allows it to be used earlier in the treatment course for younger immunocompromised patients. The expanded approval was supported by pharmacokinetic and safety data, along with extrapolation from adult clinical experience. Here is the prescribing information.