FDA Approves Renflexis as Biosimilar to Remicade

The U.S. Food and Drug Administration (FDA) has approved a biosimilar copy of Johnson & Johnson's rheumatoid arthritis drug Remicade (infliximab) called Renflexis (Infliximab-abda) following on the biologics license application of the South Korean manufacturer Samsung Bioepis Co. LTD.

Renflexis, is a “biosimilar drug” which is a copy of a biotech drug. Renflexix is the second Remicade biosimilar to be approved in the United States. The FDA approved the drug a little more than a year after the first Remicade biosimilar copy called Inflectra which was also developed by a South Korean company, Celltrion.

What are Biosimilars?

A new class of drugs called biosimilars is becoming increasingly available to consumers. Though these medications are very similar to already available drugs known as biologics, biosimilars are just now beginning to receive approval from the U.S. FDA.

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.

Renflexis is the fifth biosimilar drug to be approved by the FDA and the fourth TNF inhibitor. In 2016, the FDA approved biosimilar versions of Erelzi (etanercept), and Amjevita (adalimumab).

Renflexis will carry the same indications of the originator drug Remicade including active, moderate-severe, rheumatoid arthritis, ankylosing spondylitis, adult and pediatric Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis.

The drug is approved with the same dosing, boxed warnings (serious infections, TB, lymphoma, hepatosplenic T cell lymphoma) and warnings currently found with Remicade and Inflectra. Thus before starting Renflexis, all patients must be screened for tuberculosis.