Quick Note - Dr Reddy's Laboratories (DRRD IN) (Buy) - Biosimilar abatacept: US FDA inspection update

Research evidence excerpt

Quick Note - Dr Reddy's Laboratories (DRRD IN) (Buy) - Biosimilar abatacept: US FDA inspection update

Global Markets Research

Dr Reddy's Laboratories REDY.NS DRRD IN 28 June 2026

EQUITY: HEALTH CARE & PHARMACEUTICALS

RatingBiosimilar abatacept: US FDA inspection update Remains Buy

Target price INR 1,740 RemainsQuick Note

Closing price

25 June 2026 INR 1,351Latest update: June 2026 inspection

The US FDA completed its inspection of DRRD's Hyderabad biosimilar facility between

16–25 June 2026, resulting in seven Form 483 observations. This follows inspections in

October 2023 and September 2025 that led to nine and five observations, respectively. Research Analysts

The site comprise two blocks: an old block from which rituximab was filed and a new block India Pharmaceuticals

created for biosimilar abatacept. The company indicated that most of the observations Saion Mukherjee - NFASL

in the recent inspection pertain to the new block. It suggests that the long-standing saion.mukherjee@nomura.com

contamination concerns related to the old block may have been substantially addressed. +91 22 403 74184

Following the inspections, the company has expressed confidence in resolving the Kushal Chovatia - NFASL

observations and remains optimistic of approval and launch in 4QFY27 (i.e., January– kushal.chovatia@nomura.com

March 2028). We await details of the Form 483 observations. +91 22 403 74013

The seven-observation outcome, with the company's clarification that most relate to the

new block, is modestly encouraging. However it does not eliminate the risk of a Complete

Response Letter (CRL) on facility grounds. The key monitorable will be DRRD's response

to the observations and the US FDA's subsequent action. We expect facility clearance

to be a key hurdle.