| |APRIL 20269TEVA'S BIOSIMILARS EXPANSION ADVANCES WITH KEY FDA APPROVALLUPIN RECEIVES USFDA NOD FOR SUGAMMADEX INJECTIONTeva Pharmaceutical is accelerating its Teva's biosimilars expansion with three major milestones that strengthen its "Pivot to Growth" strategy and reinforce its position in the global biosimilars market.The company announced that the U.S. Food and Drug Administration has approved PONLIMSI (denosumab-adet), a biosimilar to Prolia. At the same time, regulatory applications for a proposed biosimilar to Xolair have been accepted by both the FDA and the European Medicines Agency."Our biosimilars R&D engine continues to demonstrate its depth and maturity. By combining deep internal expertise with strategic partnerships, we're building a highly competitive portfolio," said Steffen Nock, PhD, Head of Biosimilars R&D and Chief Science Officer at Teva. "With a strong early-stage pipeline and a suite of advancing programs, we see significant potential to address patient needs and fuel Teva's long-term growth."The FDA approval of PONLIMSI was supported by extensive analytical and clinical data confirming comparable efficacy, safety, and immunogenicity to Prolia. The biosimilar is approved for all indications of the reference drug, including osteoporosis treatment in postmenopausal women and men at high fracture risk, glucocorticoid-induced osteoporosis, and bone loss linked to cancer therapies.This Teva biosimilars expansion also highlights the company's growing global regulatory success and pipeline strength in high-demand therapeutic areas."The FDA approval of PONLIMSI is a significant milestone that showcases our robust clinical, analytical, operational and regulatory expertise," said Yolanda Tibbe. "To receive US FDA approval of PONLIMSI and the filing acceptances of our proposed biosimilar candidate to Xolair in the US and Europe truly underscores the strength of our expanding global biosimilar portfolio and reaffirms our commitment to expand treatment options for patients." POLupin Ltd has received tentative approval from the United States Food and Drug Administration for its generic version of Sugammadex injection, which is used to reverse the effects of certain muscle relaxants used during surgery.The approval has been received for Lupin's abbreviated new drug application for Sugammadex Injection in two different strengths: 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) in single-dose vials. The drug has already been found to be bioequivalent to Bridion, which is a drug developed by Merck.The drug is used to reverse neuromuscular blockade in patients who have undergone surgery, which is generally caused by rocuronium bromide and vecuronium bromide, which are administered during surgery to relax muscles. The drug can be administered in both adults and children aged two years and above.The fact that Lupin Ltd has received tentative approval from the USFDA indicates that its drug has passed all quality, safety, and efficacy tests, but its commercialization will depend on the patents and exclusivities available for the reference drug.This will further add to Lupin Ltd's portfolio in the US market, especially in the injectables segment, which is a key segment of the drug market and has witnessed steady demand.Once Lupin Ltd receives final approval, it will enable the company to enter this highly regulated and competitive market with its drug, which will help expand its presence in this market segment. PO
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