Pfizer Gets Expert Panel Nod to Update Etanercept Pre-Filled Injection Label
Pfizer
New Delhi: Following a thorough review of post-marketing safety data, published literature, and clinical trial findings, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has approved the drug major Pfizer's proposal to update Package Insert (PI) LPDENB072024 (Version July 2024) for Etanercept solution for injection, 25 mg pre-filled syringe and 50 mg pre-filled pen.
This came after the drug maker presented the proposal for update in Package Insert for the changes in the Section 4.4, Section 4.8, Section 5.2 of the drug product Etanercept Solution for Injection, 25 mg Pre-filled Syringe and 50 mg Pre-filled Pen based on the review of post marketing data, literature review and clinical trial data via Periodic Safety Update Report (PSUR).
The proposed changes include the updates in the Package Insert (PI) Version LPDENB102023 (October 2023), LPDENB032024 (March 2024), and LPDENB072024 (July 2024) in line with the approved European Union Summary of Product Characteristics (EU SmPC), Version July 2024.
Etanercept is a recombinant human tumor necrosis factor (TNF) receptor fusion protein. It acts as a biologic disease-modifying antirheumatic drug (bDMARD). It is designed to bind to TNF-α, a pro-inflammatory cytokine, preventing it from interacting with its natural cell surface receptors, thereby reducing inflammation and autoimmune responses.
Much of the joint pathology in rheumatoid arthritis and ankylosing spondylitis, and skin pathology in plaque psoriasis, is mediated by pro-inflammatory molecules that are linked in a network controlled by TNF. The mechanism of action of etanercept is thought to be its competitive inhibition of TNF binding to the cell surface TNFR, preventing TNF-mediated cellular responses by rendering TNF biologically inactive. Etanercept may also modulate biologic responses controlled by additional downstream molecules (e.g., cytokines, adhesion molecules, or proteinases) that are induced or regulated by TNF.
At the recent SEC meeting for analgesic and rheumatology held on 16th July 2025, the expert panel reviewed the proposal for update in the Package Insert for the changes in Section 4.4, Section 4.8, and Section 5.2 of the drug product Etanercept Solution for Injection, 25 mg Pre-filled Syringe and 50 mg Pre-filled Pen.
After detailed deliberation, the committee recommended the approval of the updated package insert LPDENB072024 (Version July 2024) for the proposed changes.
