The drugmaker – a joint venture between Samsung Biologics and Biogen – submitted its infliximab candidate to the US Food and Drug Administration (FDA) last year, and on Friday the Agency approved the product across all its reference biologics' indications.
Renflexis (infliximab-abda) is the first US regulatory success for the Korea-based company which has six biosimilar candidates in its pipeline, including a version of Amgen's Enbrel (etanercept) - Benepali - approved in Korea, Australia and Europe.
"Since our company was established five years ago, we have strived day in and day out to realize the promise of biosimilars for patients across the United States by offering them treatment options at a lower cost," CEO Christopher Hansung Ko said.
Merck & Co. vs J&J
The product is a biosimilar version of J&J subsidiary Janssen’s monoclonal antibody Remicade, which clocked in sales of $4.8bn in the US last year.
However, the product is facing competition from Pfizer/Celltrion’s biosimilar Inflectra which gained FDA approval last April and launched on the market in November.
But in the first quarter 2017, J&J saw little impact from Inflectra’s presence, according to CEO Dominic Caruso during a conference call last week.
“Of course, it's early because the product [Inflectra] just launched at the end of last year,” he told investors. “As you know there is no interchangeability, so we certainly don't expect that decisions will switch patients, they may start new patients on therapy.
“But with the long history that we have of Remicade’s efficacy and safety, we believe patients will move slowly to switch to a biosimilar and we've incorporated that planned utilization in our guidance for the year and hasn't changed from the time we gave guidance in January, which is well before we saw any impact in the quarter.”
Renflexis is already approved in Europe under the name Flixabi, where it competes against Remicade marketed by Merck & Co. (known as MSD outside North America). Interestingly Merck & Co. also has the marketing authority for Flixabi in the US, and so once launched the firm will be competing directly against its Remicade partner.