Dr. Reddy's Laboratories Ltd RDY
Dr. Reddy's Laboratories Ltd (NYSE: RDY) is a specialty pharmaceutical company. Its next catalyst on record is Denosumab biosimilar: US BLA resubmission after Dec 2025 complete response letter (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Denosumab biosimilar — US BLA resubmission after Dec 2025 complete response letter (2026). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Rituximab biosimilar (DRL_RI) - US BLA under active review; approved EU, UK, Switzerland, Canada | Oncology/immunology (rituximab reference indications) | antibody | Phase 3 |
| Denosumab biosimilar (with Alvotech) - US CRL Dec 2025; EU and UK approved | Osteoporosis/bone (Prolia/Xgeva reference) | antibody | Phase 3 |
| Abatacept biosimilar (IV) - US BLA pending | Rheumatoid arthritis (reference indications) | protein/peptide | Phase 3 |
| Two 505(b)(2) NDAs pending (unnamed) | — | small molecule | Phase 3 |
| Daratumumab biosimilar HLX15 (Henlius partnership) | Multiple myeloma (reference) | antibody | Pre-clinical |
| Three early-stage molecules with active pre-IND applications | — | unclear | Pre-clinical |
Recent results and decisions
- Oct 23, 2026submitted Five new ANDAs filed with the U.S. FDA during the three months ended September 30, 2026.
During the three months ended September 30, 2026, five new ANDAs and no new NDAs were filed with the U.S. FDA.
Filing - Oct 23, 2026approval Dr. Reddy's secured USFDA approval for rituximab biosimilar for the United States.
Secured approval from the USFDA for rituximab biosimilar for the United States (US).
Filing - Oct 23, 2026approval Dr. Reddy's secured India's first biosimilar approval for abatacept intravenous (IV).
Secured 1st biosimilar approval in India for abatacept intravenous (IV).
Filing
10 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.