Dr. Reddy’s Reports the US FDA’s BLA Acceptance for DRL_AB (Biosimilar, Orencia)

Shots:

• The US FDA has accepted 351 (k) BLA for DRL_AB (IV), a proposed interchangeable biosimilar to Orencia (abatacept)
• Upon approval, DRL_AB will be indicated for adults with mod. to sev. active rheumatoid arthritis, adults with active psoriatic arthritis, & pts (≥6yrs.) with mod. to sev. active polyarticular juvenile idiopathic arthritis
• BLA was supported by extensive clinical data. DRL_AB showed PK similarity with comparable safety & immunogenicity to Orencia in the P-I (AB-01-003) trial & is being evaluated in the P-III (AB-01-004) study assessing its efficacy & safety against Orencia

Ref: Businesswire  |   Image: Dr. Reddy’s  |   Press Release

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