Wire · regulatory
Dr Reddy's wins FDA nod for rituximab biosimilar
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Fusion42 · 1 August 2026 · Fusion42 review
Dr Reddy's Laboratories has received FDA approval to market its rituximab biosimilar in the US, with Fresenius Kabi holding exclusive commercialization rights. This approval follows a prior legal settlement and positions Dr Reddy's to revive its US biosimilar business after recent sales declines.
This Wire brief sits within Fusion42's coverage of Biotech, and 5 sources have reported it between 1 Aug 2026 and 14 Aug 2026.
◆ ◆ The Wire takeaway
You gain a clear entry point into the US biosimilar market, but you must now compete with multiple established players who have settled similar patent disputes with Roche. Act fast to secure partnerships or market share before pricing pressures deepen.
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5 sources · first reported 1 Aug 2026 · latest 14 Aug 2026
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