Pfizer gets CDSCO panel marketing authorization for Infliximab

However, the approval is conditional on the company conducting a Phase IV clinical trial in accordance with CDSCO guidelines for similar biologics and submitting the protocol within three months of receiving marketing approval.

This came in the wake of the proposal presented by drug-maker Pfizer for marketing authorization of Infliximab with waiver of local Phase III and IV clinical trial in the country.

Infliximab is a monoclonal anti tumor necrosis factor alpha antibody used in the treatment of a wide variety of inflammatory conditions such as rheumatoid arthritis, Crohn's disease, and ankylosing spondylitis. It is produced by a recombinant cell line cultured by continuous perfusion.

Tumor necrosis factor-alpha (TNF-α) is a proinflammatory cytokine that plays an important role in chronic inflammatory diseases. Its hyperactivity and enhanced signalling pathways can be observed in inflammatory diseases where it activates further pro-inflammatory cascades. Infliximab neutralises the biological activity of TNF-α by binding with high affinity to the soluble and transmembrane forms of TNF-α, and prevents the effective binding of TNF-α with its receptors.

Infliximab was first approved by the FDA in 1998 under the market name Remicade as an intravenous injection. There are currently two biosilimars of infliximab available in the US market that demonstrate a high degree of similarity to the reference product, Remicade. Inflectra, a first biosimilar drug product, was approved in 2016. In December 2017, Ixifi, a second biosimilar that was developed by Pfizer, was granted approval by the FDA.

The United States (U.S.) Food and Drug Administration (FDA) approved Pfizer's IXIFI, a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade (infliximab) for the treatment of patients with rheumatoid arthritis, Crohn's disease, pediatric Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

The committee, at its 75th SEC meeting for Analgesic & Rheumatology, has thoroughly examined the drug-maker Pfizer's proposal for marketing authorization of Infliximab with waiver of local Phase III and IV clinical trial in the country.

In respect to the proposal, the committee noted that the drug is approved in major ICH countries like the USA, the EU, and Japan, and the proposal was also deliberated on in the pre-submission meeting.

After detailed deliberation, the committee recommended the grant of marketing authorization with waiver of the Phase III clinical trial, subject to the condition that the firm conduct a Phase IV clinical trial as per CDSCO guidelines for similar biologics, and the protocol shall be submitted within three months of obtaining the marketing approval.