FDA BRIEF: WEEK OF APRIL 4, 2016
infliximab-dyyb for Injection
Celltrion, Inc, Yeonsu-gu, Incheon, Republic of Korea
For : Hospira, Lake Forest, Illinois, USA
INDICATIONS:
- Moderately to severely active Crohn’s disease
- Severely active ulcerative colitis
- Moderately to severely active rheumatoid arthritis
- Active ankylosing spondylitis
- Psoriatic arthritis
- Chronic severe plaque psoriasis
UNMET NEED:
- Biosimilars provide access to important treatment options
- Second FDA approved biosimilar
- Biosimilar to Janssen Biotech’s Remicade (infliximab), originally licensed in 1998
- Not an interchangeable product
REG. PATHWAY: Approval based on showing high similarity to Remicade – no clinically meaningful differences in safety and effectiveness
EVIDENCE OF SIMILARITY:
- Structural and functional characterization
- Animal study data
- Human pharmacokinetic and pharmacodynamics
- Clinical immunogenicity
- Clinical safety and effectiveness data demonstrating biosimilarity
SAFETY:
- Boxed Warning: Increased risk of serious infections leading to hospitalization/death
- Serious side effects: Liver injury, blood problems, lupus-like syndrome, psoriasis, and in rare cases nervous system disorders
- Most common expected side effects: Respiratory infections, headache, coughing and stomach pain
Emtricitabine (FTC) and Tenofovir Alafenamide (TAF) combination tablet
Gilead Sciences, Foster City, California, USA
INDICATION: Treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older. Not a complete regimen for HIV-1 treatment; must be combined with other antiretroviral agents
REG PATHWAY: Demonstration of relative bioavailability of FTC and TAF exposures vs GENVOYA (elvitegravir/cobicistat/FTC/TAF)