FDA BRIEF: WEEK OF APRIL 4, 2016 

FDA approved


 

INFLECTRA

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

LABEL


 

 

descovy

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)

DESCOVY

 

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