Lupin Gets CDSCO Panel nod To study LUBT017 Biosimilar to Eylea

Written by Dr. Divya Colin Published On 2022-10-15T18:00:15+05:30 | Updated On 28 March 2024 11:35 PM IST

Lupin Gets CDSCO Panel nod To study LUBT017 Biosimilar to Eylea

New Delhi: Directing to appoint an independent data safety monitoring committee, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has granted approval to drug major Lupin to conduct trail of the LUBT017(Proposed Biosimilar to Eylea) for the treatment of retinal vascular diseases, a major cause of visual impairment and blindness.

This approval is subjected to the condition that the firm should enroll up to 150 subjects from the country for the study.

Furthermore, the expert panel stated that the firm should appoint an independent data safety monitoring committee to monitor and assess the safety of the trail.

In addition, the committee directed the firm that if the subjects develop Choroidal neovascularization (CNV) in the fellow eye then it should be managed as per the standard of care and the cost of the same should be borne by the sponsor.

This came after the firm presented the proposed Phase III clinical trial protocol no.LRP/LUBT017/2021/003, version 1.0,of the LUBT017((Proposed Biosimilar to Eylea) before the committee.

LUBT017 is a proposed biosimilar to Eylea (aflibercept). Aflibercept, as an ophthalmic agent, is used in the treatment of macular edema following Central Retinal Vein Occlusion (CRVO) and neovascular Age-Related Macular Degeneration (AMD). Aflibercept is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration.

It acts as a decoy receptor for the ligands, vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PIGF). It prevents these ligands to binding to endothelial receptors, VEGFR-1 and VEGFR-2, to suppress neovascularization and decrease vascular permeability. This ultimately will slow vision loss or the progression of metastatic colorectal cancer.

At the recent SEC meeting for the Ophthalmology held on September 22,2022, the expert panel reviewed the proposed Phase III clinical trial protocol no.LRP/LUBT017/2021/003, version 1.0,of the LUBT017(Proposed Biosimilar to Eylea) presented by drug major Lupin.

After detailed deliberation, the committee recommended for grant of permission to conduct the trial as per the protocol with the following conditions:

1) The firm should enroll up to 150 subjects from the country.

2) The firm should appoint an independent data safety monitoring committee to monitor and assess the safety of the proposed trial.

3) If the subjects develop CNV in the fellow eye then it should be managed as per the standard of care and the cost of the same should be borne by the sponsor.

Also Read: JnJ gets CDSCO Panel nod to study antipsychotic drug Paliperidone Palmitate

lupinEyleaLUBT017afliberceptcdscosec committee

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.