Bristol-Myers Squibb announces new pediatric subcutaneous administration option for Orencia® (abatacept)

Approved Biosimilar Products  •  PTAB + IPR

We previously reported that the PTAB upheld the validity of Bristol-Myers Squibb’s ‘239 patent covering their rheumatoid arthritis agent Orencia® (abatacept). Since 2008, Orencia® has only been approved for use in patients 6 years of age and older with moderately to severely active polyarticular Juvenile Idiopathic Arthritis (JIA). However, last week, BMS announced the availability of an FDA-approved prefilled syringe for subcutaneous injection of abatacept for use in patients 2 years of age and older for that same indication. It is not yet known if Orencia® is safe and effective in children under 2 years of age.

 

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