Remsima ^TM, a biosimilar product manufactured by Celtrion may soon be granted an approval by the U.S. FDA. According to the leading biologics manufacturer in Korea, the Arthritis Advisory Committee, which was held on White Oak Campus, MD, on Feb., 9 (local time) recommended by 21 to 3 that the FDA approve the drug for all applicable indications.

The independent committee provides comprehensive opinions regarding quality, safety and affordability of drugs under review by the FDA. Although the committee does not have a direct say over the FDA's approval processes, it wields a considerable influence on the decisions the U.S. regulatory agency makes.

With the recommendation, Celltrion expects its biosimilar product to acquire an approval for sale some time in April, 2016.

If the committee recommendation is followed through, Remsima^TM will be used to treat rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis in children and adults, Crohn's disease, psoriasis and psoriatic arthritis in the U.S.

Once the approval is finalized, Resima^TM will be the first Korean firm-manufactured antibody biosimilar and second biosimilar granted an approval by the U.S. FDA. The first biosimilar product approved is Zarxio, which treats neutropenia.

Biosimilars are developed by cloning biologics, and biologic products, by nature, cause fewer adverse effects and are linked to improved efficacy, yet they involve more complicated manufacturing processes and higher costs.

Since live organisms are used to develop biologics, manufacturing identical products is impossible at best, hence the term "(bio)similar."

Remsima^TM, being approved for sale in 67 countries including the marketing authorization given by the EMA, is a widely used biosimilar product. Unlike Europe where biosimilars were introduced to the market as early as in the mid-2000's, the U.S. has been shy away from giving approvals to biosimilars for reasons including the protection of its domestic pharmaceutical industry. However, the passage of the Obama Care Act in 2012 paved a legal foundation for granting approvals for biosimilars.

The originator of Remsima is Remicade (active ingredient: Infliximab), which is a blockbuster antibody drug that raked in USD 9.885 billion (or app. 12 trillion KRW) in revenue in 2014 alone.

Its biggest market is the U.S., taking up roughly USD 4.5 billion (or app. 5.44 trillion KRW), and the U.S. market accounts for approximately half of all antibody drugs sold globally.

An official from Celtrion said, "Remsima^TM has been proven its similarity to the originator in the clinical studies, and we believe that the Advisory Committee decision is aligned with the U.S. government stance whose goal is to cut medical costs, which is possible by introducing biosmilars that are more affordable yet just as efficacious as their comparators, - a significant benefit enjoyed by its European counterparts."

Feb., 10, 2016, Yonhap News, Korea