After taking most of a decade to approve its first interchangeable biosimilar (Semglee (insulin glargine-yfgn), the U.S. Food and Drug Administration has approved three interchangeable biosimilars since the beginning of this year.

The first of these is simlandi (adalimumab-ryvk), approved on February 24th, made by Alvotech and Teva Pharmaceuticals, and interchangeable with Humira). The biosimilar, a TNF alpha inhibitor, was approved to be provided as a single-dose autoinjector delivering 40 mg/0.4 mL, for treating plaque psoriasis, Crohn's disease, ulcerative colitis, rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa, and uveitis.

The FDA also approved on March 5th two interchangeable biosimilars from Sandoz for a pair of Amgen biologic drugs: Jubbonti (denosumab-bbdz), interchangeable for Prolia (denosumab), and Wyost (denosumab-bbdz), interchangeable for Xgeva (denosumb). Jubbonti was approved for increasing bone mass in men and women (inter alia due to chemotherapeutic treatment for prostate cancer (men) and breast cancer (women), for osteoporosis (induced by glucocorticoid treatment or otherwise) in men and women, and for preventing fracture in post-menopausal women with osteoporosis. Wyost was approved for treating patients with multiple myeloma and solid tumor bone metastases, giant cell bone tumors, and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

Both Prolia and Jubbonti have a boxed warning for increased risk of severe hypocalcemia (low blood calcium levels) in patients with advanced chronic kidney disease taking osteoporosis medicine.

With these approvals, there are a total of 48 biosimilars (and 10 interchangeable biosimilars) approved by the FDA since Zarxio was approved in March 2015.

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