Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- Aug 4
- 1 min read
01/08/2026
Dr. Reddy’s secures US FDA approval for rituximab biosimilar, expanding its global oncology portfolio with Fresenius Kabi as exclusive US partner (Ref)
Dr. Reddy’s Laboratories received US FDA approval for its rituximab biosimilar (reference product: Rituxan®), a chimeric monoclonal antibody targeted against the pan-B-cell marker CD20
Fresenius Kabi will hold exclusive commercialization rights in the US market
Approval followed a successful Pre-License Inspection (PLI) at Dr. Reddy’s biologics facility in Hyderabad, underscoring its capability in complex biologics
The rituximab biosimilar is already marketed in India, EU, UK, and 25+ emerging markets, with approvals in Switzerland and Canada
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