Product Launch Details

Lupin Limited announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its biosimilar product RanluspecTM (ranibizumab-hkdz). This product is an interchangeable biosimilar referencing Lucentis® (manufactured by Genentech).

Product Specifications

  • RanluspecTM is the only interchangeable biosimilar ranibizumab approved in the United States available in both vials and pre-filled syringes (PFS)
  • Both presentations are approved in two strengths: 0.3 mg (0.05 mL of 6 mg/mL) and 0.5 mg (0.05 mL of 10 mg/mL)
  • The product is a recombinant humanized IgG1 monoclonal antibody fragment that binds and inhibits vascular endothelial growth factor A

Medical Indications

RanluspecTM 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
  • Myopic choroidal neovascularization

Management Commentary

Vinita Gupta, CEO, Lupin: "As our second U.S. 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: "The approval of Ranluspec reinforces our scientific rigor and manufacturing capabilities, advancing our efforts to build a scalable biosimilars portfolio and expanding access to high-quality, affordable therapies."

Dr. Cyrus Karkaria, President Biotechnology, Lupin: "The U.S. 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."

Corporate Background

Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with products distributed in over 100 markets. The company specializes in:

  • Branded and generic formulations
  • Complex generics
  • Biotechnology products
  • Active pharmaceutical ingredients

Lupin has a strong presence in India and the U.S. across multiple therapy areas including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health.

The company operates:

  • 15 manufacturing sites globally
  • 7 research centers globally
  • Employs over 24,000 professionals

Lupin's subsidiaries include Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.