Dr Reddy's Gets CDSCO Panel Nod for Denosumab 120 mg/1 mL Pre-Filled Syringe

New Delhi: Pharmaceutical major Dr. Reddy's Laboratories Limited has received a positive recommendation from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) for approval of Denosumab 120 mg/1 mL solution for injection in a pre-filled syringe (PFS) with an automatic needle guard, under the brand name Xgeva.

The recommendation came after the expert panel reviewed the company’s proposal for the additional presentation. However, the recommendation is subject to the company conducting an active post-marketing surveillance (PMS) study for the approved indications and including an appropriate warning regarding the presence of phenylalanine for patients with phenylketonuria on the product label, including the package insert.

At the SEC (Oncology) meeting held on September 29, 2026, the company presented its proposal seeking approval for Denosumab 120 mg/1 mL solution for injection in a PFS with an automatic needle guard, in addition to the existing Denosumab 120 mg/1.7 mL solution for injection in a vial, marketed under the brand name Xgeva®. The vial presentation has been approved in India since August 2017.

During the review, the committee noted that the proposed strength had been approved in Europe since February 2024.

Xgeva contains denosumab and is used to prevent skeletal-related complications in adults with advanced malignancies involving bone. These complications include pathological fractures, spinal cord compression and the need for radiation or surgery to bone. Its European indications also include treatment of giant cell tumour of bone in adults and skeletally mature adolescents when the tumour cannot be surgically removed or surgery is likely to cause severe morbidity.

After detailed deliberation, the expert panel recommended granting approval for the proposed pre-filled syringe presentation in line with the indications approved by the European Medicines Agency (EMA), subject to the stipulated conditions.

The SEC meeting minutes state:

“After detailed deliberation, the committee recommended for the grant of approval of Denosumab 120 mg/1mL Solution for Injection in PFS with automatic needle guard; in line with the indications approved by EMA and subject to the following conditions:

1. The firm shall conduct the active PMS study for the approved indications.

2. The firm shall include an appropriate warning regarding the presence of phenylalanine for patients with phenylketonuria on the product label including Package Insert.”

The committee further specified:

“Accordingly, the protocol to conduct the active PMS study shall be submitted within three months of grant of approval for proposed strength.”