Lupin Limited announced it has successfully completed a global phase 3 clinical study evaluating LUBT010, its biosimilar candidate for Genentech, Inc.’s Lucentis (ranibizumab) 0.5 mg (10 mg/mL) for wet age-related macular degeneration (AMD).
First up: a rundown on Lupin.
The Mumbai, India-based multinational generic pharmaceutical company is developing and commercializing a portfolio of branded and generic formulations, biotechnology products, and active pharmaceutical ingredients (APIs).
Click here for the company’s generic product list.
- To note: Its U.S. subsidiary is headquartered in Baltimore, Maryland.
And its recent U.S.-based news?
Just this year, the company has:
- Received FDA approval for the abbreviated new drug application (ANDA) of loteprednol etabonate ophthalmic suspension 0.2%, a generic equivalent to Alrex, Bausch + Lomb, Inc.’s reference-listed drug
- Launched bromfenac ophthalmic solution, 0.07%, the generic equivalent of Bausch + Lomb’s Prolensa ophthalmic solution, 0.07%
- Received FDA approval for the ANDA of its BromSite (bromfenac ophthalmic solution) 0.075% generic equivalent to treat postoperative inflammation and ocular pain
Zero in on ranibizumab.
The recombinant humanized lgG1 monoclonal antibody fragment binds to and inhibits (ie: blocks) vascular endothelial growth factor (VEGF-A), which is a protein that promotes angiogenesis within the body and eye.
- What this results in: Ranibizumab then disrupts VEGF’s angiogenesis process and prevents the growth of new blood vessels.
Talk about Lucentis for a moment.
Initially FDA approved in 2006, Lucentis is indicated to be administered via an intravitreal injection (IV) for the following retinal diseases:
- Wet AMD
- Macular edema following retinal vein occlusion (RVO)
- Diabetic macular edema (DME)
- Diabetic retinopathy (DR)
- Myopic choroidal neovascularization (mCNV)
And its dosing schedule?
Per the therapeutic’s prescribing information (PI), 0.5 mg (0.05 mL of 10 mg/mL solution) is intended to be administered once a month (every 28 days, approximately).
- Note: Though not as effective, the PI noted that patients may be treated:
- With 3 monthly doses followed by less frequent dosing (with regular assessment)
- With one dose every 3 months after four monthly doses (with regular assessment)
Now this ranibizumab biosimilar.
With Genentech’s ranibizumab patent expiring in the U.S. in June 2022 (and in July 2022 in the European Union), a number of NDAs and biosimilar approvals have since arisen.
In the case of Lupin: In 2022, the company began marketing its LUBT010—under the brand name RaniEyes—as its third biosimilar approved in India for wet AMD, diabetic macular oedema (DMO, aka DME), RVO, and mCNV.
So about this phase 3 clinical data …
Lupin designed its global phase 3 study based on input from both the FDA and European Medicines Agency (EMA) to evaluate.
- The design: Prospective, double-blind, multicentric, randomized study
- The purpose: To evaluate the safety, efficacy, and immunogenicity of LUBT010 when compared to Lucentis for wet AMD
- The participants: 600 wet AMD patients from the U.S., European Union (EU), India, and Russia The setup: Participants randomized (1:1) to receive either LUBT010 or Lucentis via an intravitreal injection (IV)
- The dosing duration: Once a month for 12 months
What was measured?
Per Lupin, the primary endpoint involved therapeutic equivalence between the two therapeutics in visual acuity (VA) improvement for wet AMD patients.
And these positive findings?
The company reported that the study met its primary endpoint, “comparable safety and immunogenicity between LUBT010 and Lucentis.”
Note: The complete study findings are currently not publicly available.
So how will this data be utilized?
The plan is for Lupin to use the positive findings as part of its application for market approval with both the FDA and EMA.
The timeline: “We will be filing marketing applications for LUBT010 in all major global markets this year,” stated Cyrus Karkaria, PhD, Lupin Biotech president.