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Dr. Reddy’s Files aBLA for Orencia® (abatacept) Biosimilar DRL_AB

by Robert S. Schwartz, Ph.D.
January 27, 2026

On January 21, 2026, as part of an earnings call, Dr. Reddy’s announced the filing of an aBLA for an intravenous (IV) formulation of DRL_AB (abatacept), a proposed biosimilar of Bristol-Myers Squibb’s Orencia® (abatacept) in December 2025.  This is the first publicly disclosed aBLA filing for an Orencia® biosimilar.

Dr. Reddy’s hopes to launch its IV formulation of DRL_AB by the end of 2026 and is also developing a subcutaneous formulation that it hopes to launch in early 2028.  According to statements in Dr. Reddy’s earnings call, there are currently no other companies that have finished Phase III trials for abatacept biosimilars, so it is possible they will be the first company to launch a biosimilar in both the U.S. and Europe.

Currently there are no pending patent disputes related to Orencia®, and there are no patents listed for Orencia® in the FDA’s Purple Book.

Bristol-Myers Squibb reported $2.77 billion in U.S. sales for Orencia®.

For more information on these and other biosimilars and related patent disputes, please visit BiologicsHQ.com.

 

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The author would like to thank April Breyer Menon for her contributions to this article.

    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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