Lupin secures FDA approval for Ranluspec™, an interchangeable biosimilar to Lucentis® for retinal diseases, while Alembic gains clearance for generic Haloperidol Tablets. The milestones highlight Indian pharma’s growing role in complex biosimilars and generics, expanding patient access to affordable therapies in ophthalmology and psychiatry.
Written By: Kalyani Boharapi,
M.Pharm (Reg. Affairs)
Reviewed By: Pharmacally Editorial Team
Lupin Wins FDA Approval for Ranluspec™
Lupin announced that the U.S. Food and Drug Administration (FDA) has approved Ranluspec™ (ranibizumab-hkdz), an interchangeable biosimilar referencing Lucentis® (ranibizumab). The approval covers both reference strengths and includes vial and pre-filled syringe presentations.
Ranluspec is indicated for wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy, macular edema following retinal vein occlusion, and myopic choroidal neovascularization conditions that represent leading causes of vision loss globally.
Market Context and Interchangeability Significance
Lucentis® historically generated over USD 1 billion annually in U.S. sales prior to the entry of biosimilar competitors. Ranluspec enters a competitive anti-VEGF market alongside other ranibizumab biosimilars, expanding treatment options for patients and healthcare providers.
The FDA’s interchangeability designation is particularly notable. Unlike standard biosimilarity, interchangeability requires additional evidence demonstrating that patients can be switched between the biosimilar and reference product without compromising safety or efficacy. The designation permits pharmacy-level substitution in accordance with state pharmacy laws and may accelerate adoption, broaden access, and increase competition in the ophthalmology market.
Alembic Receives FDA Approval for Haloperidol Tablets
Alembic Pharmaceuticals separately announced FDA approval of its Abbreviated New Drug Application (ANDA) for Haloperidol Tablets, a generic version of a widely used first-generation antipsychotic medication.
Haloperidol remains an established treatment for schizophrenia and other psychotic disorders, conditions characterized by hallucinations, delusions, disorganized thinking, and impaired social functioning. Its inclusion on the WHO Essential Medicines List underscores its global importance. Alembic’s approval strengthens its psychiatric portfolio and supports continued access to cost-effective treatment options in the United States.
Regulatory and Clinical Impact
The approvals highlight the advancing capabilities of Indian pharmaceutical manufacturers in developing complex generics and biosimilars for highly regulated global markets. For Lupin, Ranluspec expands its ophthalmology and biologics footprint, aligning with key strategic growth priorities. For Alembic, the approval reinforces its U.S. generics portfolio and strengthens its presence in psychiatric care.
Together, these milestones reflect the evolution of Indian pharmaceutical companies from traditional generic drug suppliers to increasingly sophisticated global healthcare players capable of competing across specialty, biologic, and complex generic markets.
Outlook for Patient Access
The approvals are expected to enhance treatment availability across two important therapeutic areas. Increased competition in the anti-VEGF market may help improve patient access to sight-preserving therapies for retinal diseases, while additional generic supply of haloperidol can support affordable long-term treatment options for patients living with serious psychiatric disorders. Together, the approvals reinforce the important role of biosimilars and generics in improving healthcare accessibility and supporting sustainable healthcare systems.
Global Competitiveness
As regulatory standards for complex generics and biosimilars continue to evolve, these approvals demonstrate the growing technical, scientific, and manufacturing capabilities of Indian pharmaceutical companies. These FDA clearances strengthen the global competitiveness of Lupin and Alembic while reinforcing the broader role of Indian drugmakers in expanding access to high-quality, affordable medicines in the U.S. healthcare system.
Reference
Lupin Receives Approval from U.S. FDA for RanluspecTM (ranibizumab) Injection
About the Writer
Kalyani Boharapi (LinkedIn) is a pharmacy professional and healthcare writer currently pursuing an M.Pharm in Regulatory Affairs at Dr. D. Y. Patil College of Pharmacy, with interests in pharmaceutical regulations, drug development, and healthcare innovation. She has academic exposure to dossier preparation, scientific writing, and regulatory documentation. Kalyani has also completed certification courses in Generative AI, AI in Pharma, and Bioinformatics, and actively participates in pharmaceutical conferences to stay updated with emerging trends and advancements in the healthcare and pharmaceutical industry.
