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What is the story about?
Pharmaceutical firm Lupin Ltd on Thursday (June 4) said it has received approval from the United States Food and Drug Administration (USFDA) for Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar referencing Lucentis of Genentech.
The company said Ranluspec is the only interchangeable biosimilar ranibizumab approved in the United States in both vial and pre-filled syringe (PFS) presentations.
Both the vial and pre-filled syringe formats have been approved in the two strengths available for Lucentis: 0.3 mg (0.05 mL of 6 mg/mL) and 0.5 mg (0.05 mL of 10 mg/mL). Ranibizumab is a recombinant humanised IgG1 monoclonal antibody fragment that binds and inhibits vascular endothelial growth factor A.
Also Read: Lupin’s US business to stay above $1 billion; biosimilars and specialty portfolio to drive growth
The drug is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularisation.
Vinita Gupta, CEO, Lupin, said, “As our second US biosimilar Ranibizumab adds depth to our biosimilars portfolio, reflecting our progress in complex biologics while expanding patient access to proven vision therapies."
Nilesh Gupta, Managing Director, Lupin, said, “The approval of Ranluspec reinforces our scientific rigour and manufacturing capabilities, advancing our efforts to build a scalable biosimilars portfolio and expanding access to high-quality, affordable therapies."
Also Read: Lupin Q4 profit nearly doubles on strong US business, revenue surges 32%
"The US FDA approval of our biosimilar ranibizumab underscores our scientific expertise in biologics development and manufacturing, and reinforces our commitment to expanding access to advanced, affordable therapies for patients worldwide,” said Dr Cyrus Karkaria, President of biotechnology, Lupin.
Last month, Lupin said it had received approval from the United States Food and Drug Administration (U.S. FDA) for its abbreviated new drug application for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets, 1.479 g/0.225 g/0.188 g.
The company said the product is bioequivalent to the reference listed drug, Sutab tablets of Azurity Pharmaceuticals, Inc. Lupin added that it is the exclusive first-to-file applicant for the product and is eligible for 180-day generic drug exclusivity. The tablets will be manufactured at the company’s Nagpur facility in India.
Also Read: Lupin unit Nanomi to acquire remaining 43.38% stake in Philippines arm for up to $39.6 million
Shares of Lupin Ltd ended at ₹2,251.00, down by ₹10.05, or 0.44%, on the BSE.
The company said Ranluspec is the only interchangeable biosimilar ranibizumab approved in the United States in both vial and pre-filled syringe (PFS) presentations.
Both the vial and pre-filled syringe formats have been approved in the two strengths available for Lucentis: 0.3 mg (0.05 mL of 6 mg/mL) and 0.5 mg (0.05 mL of 10 mg/mL). Ranibizumab is a recombinant humanised IgG1 monoclonal antibody fragment that binds and inhibits vascular endothelial growth factor A.
Also Read: Lupin’s US business to stay above $1 billion; biosimilars and specialty portfolio to drive growth
The drug is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularisation.
Vinita Gupta, CEO, Lupin, said, “As our second US biosimilar Ranibizumab adds depth to our biosimilars portfolio, reflecting our progress in complex biologics while expanding patient access to proven vision therapies."
Nilesh Gupta, Managing Director, Lupin, said, “The approval of Ranluspec reinforces our scientific rigour and manufacturing capabilities, advancing our efforts to build a scalable biosimilars portfolio and expanding access to high-quality, affordable therapies."
Also Read: Lupin Q4 profit nearly doubles on strong US business, revenue surges 32%
"The US FDA approval of our biosimilar ranibizumab underscores our scientific expertise in biologics development and manufacturing, and reinforces our commitment to expanding access to advanced, affordable therapies for patients worldwide,” said Dr Cyrus Karkaria, President of biotechnology, Lupin.
Last month, Lupin said it had received approval from the United States Food and Drug Administration (U.S. FDA) for its abbreviated new drug application for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets, 1.479 g/0.225 g/0.188 g.
The company said the product is bioequivalent to the reference listed drug, Sutab tablets of Azurity Pharmaceuticals, Inc. Lupin added that it is the exclusive first-to-file applicant for the product and is eligible for 180-day generic drug exclusivity. The tablets will be manufactured at the company’s Nagpur facility in India.
Also Read: Lupin unit Nanomi to acquire remaining 43.38% stake in Philippines arm for up to $39.6 million
Shares of Lupin Ltd ended at ₹2,251.00, down by ₹10.05, or 0.44%, on the BSE.
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