Dr. Reddy's CEO Concedes FDA Could Still Reject Its Abatacept Biosimilar: 'There Is A Chance'
Erez Israeli says the company is preparing a December US launch and sees a 15% to 25% share for the intravenous version.
Dr. Reddy's Laboratories CEO Erez Israeli said on the company's earnings call Friday that its abatacept biosimilar could still draw a rejection from the FDA, even as management prepares to launch in the US in December. "If you ask me, is there a chance that we'll get a CRL, there is a chance," he told a Citi analyst, referring to a complete response letter, the FDA's notice that it will not approve an application as submitted.
Confidence, with a caveat
Pressed by the Citi analyst for odds, Israeli leaned on experience: "I'm 33 years in this business." He said the company feels good about the product, the inspection and its correspondence with the FDA, and wants to launch in December. "Obviously, none of us want it, but there is a chance," he said of a rejection.
Asked by a BNP Paribas analyst about the goal date, Israeli said the plant went through inspection, the company is still waiting for the inspection report, and the goal date is December 22. "We are hoping for an approval," he said, adding that the decision rests with the FDA.
Dr. Reddy's, which makes generics, biosimilars, active ingredients and consumer health products, will manufacture the drug at its Bachupally facility, Israeli confirmed to a JPMorgan analyst.
A 15% to 25% share target
Israeli said Dr. Reddy's would initially be alone against the innovator product, and that because the drug is a medical-benefit product in the US, sensitivity to price and market share is lower than in pharmacy benefit. A fair share, he said, "can be any number from 15% to 25%," depending on the launch. That range applies initially to the intravenous version.
Sales can start in small quantities from day one, he said, but the ramp-up would come about six months after approval, once registration codes and formulary listings are in place. The sales framework in North America was started three years ago, he said, with a couple more sales teams still to be hired and little incremental cost expected.
The under-the-skin version follows
The subcutaneous version is next. Israeli said the company is supposed to submit that filing in February, and the intravenous product would be joined by it afterward. A JPMorgan analyst cited prior guidance of US approval for the subcutaneous form in the fourth quarter of fiscal 2028 and non-US approvals for both forms in the first quarter of fiscal 2028; Israeli replied that the timelines are consistent.
Europe, he said, would launch a little after the US and is a significant market.
The next date that matters is December 22, the goal date Israeli gave for the FDA decision.
Sources
- Dr Reddy's Laboratories Q2 2027 Earnings Call Transcript — benzinga.com
