Dr. Reddy's biosimilar to arthritis drug Orencia hits FDA review
The USFDA accepted Dr. Reddy's 351(k) BLA for review for its proposed biosimilar to Orencia, a drug used for treating arthritis.
This is the first time an abatacept biosimilar has reached this stage.
No market-timing provided in the source; timeline for market entry not specified.
DRL_AB showed pharmacokinetic similarity to Orencia in early studies
Early studies showed Dr Reddy's DRL_AB achieved pharmacokinetic similarity to Orencia with comparable safety and immunogenicity profiles.
A larger Phase 3 trial is underway to confirm its efficacy and safety.
Potential market for DRL_AB
Orencia rakes in nearly $2.8 billion in US sales every year, but there are no patents listed for Orencia in the FDA's Purple Book and there are no pending patent disputes—which could reduce patent-related obstacles for Dr Reddy's.
If all goes well, DRL_AB could be the first abatacept biosimilar available in both the US and Europe, offering new options for people with rheumatoid arthritis and related conditions.