The FDA has approved two biosimilars for the treatment of multiple inflammatory diseases, Erelzi (etanercept, Amgen), and Amjevita (adalimumab-atto, Amgen), a biosimilar to Humira (adalimumab, AbbVie).
“The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases.” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.
Erelzi is the third biosimilar approved by the FDA since 2015, and Amjevita is the fourth.
Erelzi is administered by injection for the treatment of:
moderate to severe rheumatoid arthritis, either as a standalone therapy or in combination with methotrexate (MTX);
moderate to severe polyarticular juvenile idiopathic arthritis in patients ages two and older;
active psoriatic arthritis, including use in combination with MTX in psoriatic arthritis patients who do not respond adequately to MTX alone;
active ankylosing spondylitis (an arthritis that affects the spine); and
chronic moderate to severe plaque psoriasis in adult patients (18 years or older) who are candidates for systemic therapy or phototherapy.
Amjevita is approved for the following indications in adult patients:
moderately to severely active rheumatoid arthritis;
active psoriatic arthritis;
active ankylosing spondylitis (an arthritis that affects the spine);
moderately to severely active Crohn’s disease;
moderately to severely active ulcerative colitis; and
moderate to severe plaque psoriasis.
Amjevita is also indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients four years of age and older. In addition, Amjevita is indicated for the treatment of Crohn’s disease and ulcerative colitis.
Both biological products are approved for the treatment of four types of arthritis (rheumatoid, polyarticular juvenile idiopathic psoriatic, active ankylosing spondylitis) and plaque psoriasis.
Biological products are generally derived from a living organism and can come from many sources, including humans, animals, microorganisms or yeast.
A biosimilar is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law.
Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses for both biosimilars.
Source: US Pharmacist