Shanghai Henlius Biotech Receives Approval Letter From FDA For BILDYOS, BILPREVDA

(RTTNews) - The board of Shanghai Henlius Biotech said, recently, the Group has received an approval letter from the FDA, in which the BLA for the two products, namely BILDYOS and BILPREVDA, was approved by the FDA. The product names are registered in the US in the name of N.V. Organon. Following the approvals, the Group now has a total of six products approved for marketing overseas. The approved indications are for osteoporosis.

The FDA's approval is primarily based on a review of a series of comparative study data between HLX14 and the reference product, Prolia. HLX14 is a denosumab biosimilar independently developed by Shanghai Henlius Biotech. It is intended for the treatment of osteoporosis in postmenopausal women at high risk for fracture and/or for other indications consistent with the label of the reference biologics.

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