A couple of significant 351(k) applications were accepted by the Food and Drug Administration in the month of October for denosumab biosimilars.
Teva announced that its applications for denosumab candidate TVB-009P were accepted by the European Medicines Agency as well as the FDA in early October. The application included data from a phase 3 trial of TVB-009P versus Amgen’s Prolia® in women with postmenopausal osteoporosis.
“The filing acceptance and validation of TVB-009P, our proposed biosimilar to Prolia, underscores Teva’s commitment to broadening global access to biosimilars in both regions,” said Steffen Nock, PhD, Head of Biosimilars and Chief Scientific Officer at Teva.
Shanghai Henlius Biotech and its commercialization partner Organon announced on October 30 that their biologic licensing application for HLX14 was also accepted by the FDA. Its filing was supported by a double-blind, randomized, parallel-controlled, single-dose, four-arm study with the primary objective to compare the pharmacokinetic similarity of HLX14 with US-, EU-, and China-sourced reference product. In addition, they included the results of a phase 3 double-blind, multicenter, study comparing the efficacy, safety, tolerability, and immunogenicity of HLX14 with EU-sourced reference Prolia in postmenopausal women with osteoporosis at high risk for fracture.
Neither of these two manufacturers tested their product in clinical studies with Xgeva®, for its bone metastases indications in patients with cancer.
The denosumab pipeline is extremely broad, with potentially 12 competitors launching in 2025 or later. Only one product has been approved to date—Sandoz’s Jubbonti®/Wyost®, which is set to launch by May 31, 2025.
FDA Approves New Ustekinumab Biosimilar, Imuldosa™
Partners Accord Biopharma and Intas Pharmaceuticals received FDA approval for Imuldosa (ustekinumab-srlf) on October 14, making this the fifth market entrant to challenge the reference product Stelara®.
FDA approval of Imuldosa was granted based on a comprehensive clinical development program. The data showed that Imuldosa is similar to its reference product Stelara in terms of pharmacokinetic characteristics, safety, tolerability, and efficacy, and that Imuldosa adheres to current biosimilar guidance from the FDA.
Binish Chudgar, Vice Chairman and Managing Director, Intas Pharmaceuticals, said in their press release, “As our presence in the biosimilar market continues to grow, so does our commitment to offering high quality, affordable alternatives to reference drugs, so that more patients can access the treatments they need to thrive.”
As the other ustekinumab biosimilars are expected to launch in the January to March 2025 timeframe, Accord expects to market Imuldosa sometime in the first half of 2025.
