FDA BRIEF: Week of August 21, 2017

CYLTEZO (adalimumab-adbm)

Boehringer Ingelheim Pharmaceuticals, Inc.

INDICATIONS:

• Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.
• Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older.
• Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.
• Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active ankylosing spondylitis.
• Adult Crohn’s Disease (CD): reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
• Ulcerative Colitis (UC): inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP).
• Plaque Psoriasis (Ps): the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.

REG PATHWAY: BLA

• Second Biosimilar to Humira
• Highly similar to reference product (Humira) with no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products
• Several deferred pediatric asessments

Information on Biosimilars

LABEL

Image Credit: Boehringer Ingelheim