Dr. Reddy's pegfilgrastim
Pegfilgrastim biosimilar developed by Dr. Reddy's Laboratories. Reference product Neulasta.
About Dr. Reddy's pegfilgrastim
Dr. Reddy's received its pegfilgrastim permission in India in January 2011, a year after Gennova, and sold it as one of its early biosimilars alongside rituximab and darbepoetin.
Status by market
United States
Not listed by FDA.
European Union
Not listed by EMA.
United Kingdom
Not listed by MHRA.
Japan
Not listed by PMDA.
Canada
Not listed by HC.
India
Central Drugs Standard Control OrganisationApprovedUnited Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Dr. Reddy's pegfilgrastim holds an approval, these are the other pegfilgrastim biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| CDSCO | 5 | Gennova Biopharmaceuticals (Gennova pegfilgrastim), Lupin (Armlupeg / Lupin pegfilgrastim), USV (USV pegfilgrastim), Virchow Biotech (Virchow Biotech pegfilgrastim), Wockhardt (Wockhardt pegfilgrastim) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Dr. Reddy's Laboratories: Dr. Reddy's bevacizumab, Dr. Reddy's darbepoetin alfa, Dr. Reddy's trastuzumab, Teriparatide Dr. Reddy's, Zimrixby / Ituxredi.
Chronology
- CDSCOJan 2011CDSCO permission granted
Sources
S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)
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