The Food and Drug Administration’s Arthritis Advisory Committee recommended that Amgen biosimilar (ABP 501) to Humira (adalimumab) be approved for use in the United States. The panel unanimously voted, 26-0, that ABP 501 be recommended for use in the same indications as adalimumab: rheumatoid arthritis (RA), juvenile idiopathic, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, adult Crohn’s disease, and adult ulcerative colitis. Abbvie maker of Humira has now sued Amgen for patent infringement and this is likely to tie up the availability of the Amgen biosimilar for some time.
ABP 501 is the biosimilar adalimumab and targets tumor necrosis factor-alpha (TNF-α) in the management of RA and multiple inflammatory diseases. Biosimilar medications are very similar to already available drugs known as biologics, biosimilars are just now beginning to receive approval from the U.S. Food and Drug Administration (FDA).
What is a Biosimilar?
To understand biosimilars and how they work, it’s important to first understand their predecessors, biologics. These drugs are approved by the FDA and used in treatment of a wide range of conditions and illnesses, from rheumatoid arthritis and inflammatory bowel disease to various forms of cancer as well as allergy shots and vaccines. Biologics are made from living organisms, including human sources, animals, bacteria, and yeast. Their makeup is incredibly complex, as is their development process.
A drug qualifies as a biosimilar if it is very similar to a FDA-approved biologic—similar in how it’s composed, how it works, and its safety. The preceding biologic drug is often called a reference medicine.
Biosimilars are different from generic medicines. Whereas generics and the original (trademarked) drug have identical active ingredients, such exact replication isn’t possible due to the complexity of biologics. As a result, biosimilars are similar to the reference medicine, but not identical. They must have very similar treatment outcomes and safety profiles to the biologic.
The aim of approving biosimilars and bringing them to the market is to increase access to biological medicines and reduce costs (compared with reference medicines). Access to healthcare is increasingly important around the world as we have aging populations and increasing incidence of chronic disease.
Once approved, a biosimilar an be used for multiple indications based on a single indication (RA) clinical trial is a unique feature of the 351(k) regulatory pathway (also known as the abbreviated development program). Thus, the sponsor can perform a single indication study in RA and also request the same indications achieved by the reference product (e.g., Humira) such as Crohn’s, ulcerative colitis, psoriasis, psoriatic arthritis, and ankylosing spondylitis.