Submit PSUR data: CDSCO Panel Tells Shilpa on additional indication of Rheumatoid Arthritis drug Adalimumab
New Delhi: In response to the proposal presented by the drug major Shilpa for the extrapolation of indications for Adalimumab 100mg/mL approved in India for the indication of Rheumatoid Arthritis (RA) in adult patients, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the firm to submit periodic safety update report (PSUR) data for the first six months for consideration of approval for the additional indications.
This came after the firm presented the proposal for extrapolation of indications in line with the innovator-approved indications for Adalimumab 100mg/mL approved in India for the indication of Rheumatoid Arthritis (RA) in adult patients.
The committee noted that the firm has recently launched the drug product in the market and has not yet submitted the first PSUR.
Adalimumab injection products are in a class of medications called tumor necrosis factor (TNF) inhibitors. They work by blocking the action of TNF, a substance in the body that causes inflammation.
Adalimumab is a type of drug known as a biological therapy. In rheumatoid arthritis and some other conditions, too much of a protein called TNF is produced in the body. This causes inflammation, pain, and damage to your joints.
Adalimumab is the first fully human recombinant immunoglobulin G1 monoclonal antibody that binds and neutralizes soluble and membrane-bound tumor necrosis factor (TNF) so that it cannot interact with p55 and p75 cell-surface TNF receptors.
At the recent SEC meeting for analgesic and rheumatology held on 8th and 9th November 2023, the expert panel reviewed the proposal for extrapolation of indications in line with the innovator-approved indications for Adalimumab 100mg/mL approved in India for the indication of Rheumatoid Arthritis (RA) in adult patients presented by drug major Shilpa.
After detailed deliberation, the committee recommended that the firm should submit PSUR data for the first six months for consideration of approval for the additional indications.
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