Dr. Reddy’s Laboratories on Friday (September 6, 2024) said it has received the establishment inspection report (EIR) from the U.S. health regulator for its active pharmaceutical ingredient manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh.

The U.S. Food and Drug Administration (USFDA) has classified the inspection as Voluntary Action Indicated (VAI) and concluded that the inspection is close, the Hyderabad-based drug maker said in a statement.

As per USFDA, VAI means that objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

On June 7 this year, Dr. Reddy’s had stated that the U.S. health regulator has issued Form 483 with four observations after inspecting its Srikakulam-based facility.

Shares of the company on Friday ended 0.42% down at ₹6,669.75 apiece on the BSE.

Dr. Reddy’s had previously received EU (Good manufacturing practice) GMP certificate for its Rituximab drug substance and drug product manufacturing facility located in Hyderabad. 

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending launch of Dr. Reddy’s Laboratories’ proposed biosimilar Rituximab candidate DRL_RI (Ituxredi) in European markets.

Announcing this in a release on July 29, the Hyderabad-based drugmaker said as part of the approval process, the CHMP opinion will now be reviewed by the European Commission (EC) post which a decision made on the grant of marketing authorisation in the European Union member countries and the European Economic Area member states of Norway, Iceland, and Liechtenstein.

“The company intends to file a marketing authorisation application to the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) separately in line with the reliance route under the International Recognition Procedure (IRP),” the release said.

Dr. Reddy’s had previously received EU (Good manufacturing practice) GMP certificate for its Rituximab drug substance and drug product manufacturing facility located in Hyderabad.

DRL_RI is being developed a biosimilar of Roche’s MabThera, a cluster of differentiation 20 (CD20) directed cytolytic antibody. It is intended for indications as those currently approved for MabThera, which are Non–Hodgkin’s Lymphoma (NHL); Chronic Lymphocytic Leukaemia (CLL); Rheumatoid Arthritis (RA); Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA); Pemphigus Vulgaris (PV).

While the reference medicinal product for the biosimilar in the EU is MabThera, the reference product in the U.S. is Rituxan of Roche. Dr. Reddy’s biologics licence application for the proposed biosimilar rituximab candidate in the U.S. got accepted for a review by the U.S. Food and Drug Administration in July 2023.

“The biosimilar has been approved for marketing in India and more than 25 emerging markets. While it is collaborating with Fresenius Kabi, a global health care company, to commercialise the proposed biosimilar in the U.S, it intended to commercialise the product in Europe and other geographies directly,” Dr. Reddy’s had said last year.

In the latest annual report, for 2023-24, Chairman K. Satish Reddy Co-Chairman and Managing Director G. V. Prasad said “our dossier for proposed rituximab biosimilar candidate received a complete response letter from the U.S. FDA. We will continue to work closely with the U.S. FDA to address and resolve all concerns within stipulated timelines in order to make this biosimilar rituximab available to patients in the U.S. as soon as possible.”