Lupin Limited has received FDA approval for Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar to Genentech’s Lucentis (ranibizumab injection).
First things first: a look at biosimilars vs generics.
Here are a few key distinctions between these two types of off-brand drugs:
- Generics are designed as exact chemical copies of their reference biologics (name-brand drug counterpart).
- Biosimilars, on the other hand, are highly similar (but not identical) versions of their reference biologics, with minor differences allowed—providing they don’t result in clinically meaningful differences in the resulting safety and efficacy.
Now to this biosimilar of interest—what do we know?
Ranluspec (ranibizumab-hkdz) is an interchangeable biosimilar to Genentech’s Lucentis, a vascular endothelial growth factor (VEGF) inhibitor initially granted U.S. regulatory clearance in 2006.
- See here for details on the biosimilar’s regulatory status outside of the United States.
And this isn’t the first Lucentis biosimilar to be approved, right?
Correct. Lupin’s product is the third ranibizumab biosimilar to receive FDA approval after Genentech’s ranibizumab patent expired in the United States in June 2022. Prior approvals include:
- Formycon AG’s FYB201/CIMERLI (in 2022)
- Formycon and Bioeq AG’s Nufmyco (in December 2025)
Let’s talk indications.
The biosimilar is approved for all five of Lucentis’s indications retinal indications:
- Wet age-related macular degeneration (AMD)
- Diabetic macular edema (DME
- Diabetic retinopathy (DR)
- Macular edema due to retinal vein occlusion (RVO)
- Myopic choroidal neovascularization (mCNV)
And their respective dosings?
Prescribing information (PI) for Ranluspec was not immediately available.
However, considering the intravitreally (IVT)-injected therapeutic is identical to its name-brand counterpart, we’ll refer to Lucentis’ PI for those details.
Any contraindications or precautions to be aware of?
Still looking at that PI (see Section 4.1), the IVT injection is contraindicated in patients with:
- Ocular or periocular infections
- Hypersensitivity to ranibizumab or any of the excipients in the drug
- Reactions may develop as severe intraocular inflammation (IOI)
And a few of the potential adverse reactions (as per Section 5) include:
- Endophthalmitis and retinal detachments
- Intraocular pressure (IOP) increases
- Arterial thromboembolic events
- Potential fatal events (though risk is low, a possible relationship tied to IVT use of VEGF inhibitors can’t be ruled out)
- Retinal vasculitis with or without occlusion (typically in the presence of preexisting IOI or post-treatment with other IVT agents)
… is that it?
Not quite. A complete look at reported ocular reactions among ranibizumab-treated patients (versus placebo) in clinical trials can be found in Section 6 of the PI.
- The most common: conjunctival hemorrhage, eye pain, and vitreous floaters.
Speaking of clinical trials—was Ranluspec the subject of any original evaluations?
Indeed it was—a global phase 3 program, in fact, involving 600+ wet AMD patients from the U.S., European Union, Russia, and India.
As we reported in August 2024, that clinical study met its primary endpoint of demonstrating therapeutic equivalence between the biosimilar and Lucentis via visual acuity improvement.
This clinical data was used to support the biosimilar’s marketing approval from both the U.S. and European Medicines Agency.
Nice! And what do we know about its commercialization plans?
No details as of yet for a timeframe on when Ranluspec will be commercially available.
However, Lupin did note that it’s the only ranibizumabranibizimab biosimilar FDA-approved in two forms (vials and pre-filled syringes [PFS])—and in two strengths:
- 0.3 mg (0.05 mL of 6 mg/mL)
- 0.5 mg (0.05 mL of 10 mg/mL)
Stay tuned for updates!