HONG KONG – Samsung Bioepis Co. Ltd.'s biosimilar Renflexis (infliximab-abda) will be the first product of the conglomerate's biologics arm to be marketed in the U.S. and only the second infliximab biosimilar in the market after Pfizer Inc.'s Inflectra. Samsung Bioepis gained FDA approval late Friday for its BLA for Renflexis (formerly SB2), a biosimilar candidate referencing Remicade (infliximab, Janssen Biotech Inc.).

The biosimilar will be marketed and distributed in the U.S. by Merck & Co. Inc., of Kenilworth, N.J.

"We are on a trajectory to become a world leader in biosimilars, as we see more approvals in various territories, including the first etanercept biosimilar in Europe and North America," Mingi Hyun, a spokesman for Samsung Bioepis, told BioWorld Asia. "This is only the beginning as we continue to develop one of the industry's largest and strongest biosimilar pipelines."

Renflexis references the blockbuster Remicade, used for the treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. Like Inflectra, which the FDA approved a year ago, Renflexis was cleared for all but one of Remicade's indications, as the innovator has pediatric exclusivity on pediatric ulcerative colitis until September 2018. (See BioWorld Today, April 13, 2016.)

"When we started out in 2012, we chose to develop biosimilars, as we saw biosimilars as a good entry point into the biopharmaceutical industry," Hyun said. "At the time, biosimilars were more or less new to everyone, and we had the confidence that our platform and engineers could capitalize on the level playing field, thereby allowing us to compete from the start and eventually capture pole position."

Samsung is now the world's biggest contract biologic drugmaker by volume.

The price of Renflexis has not been announced, but the two biosimilars launched so far in the U.S. – Inflectra and Sandoz Inc.'s Zarxio (filgrastim) – are offering about a 15 percent discount from the innovator product. Since Renflexis would be the second infliximab to launch in the U.S., analysts have suggested the price could drop further as it enters the market.

Renflexis will be available for launch following a 180-day notice period from the FDA approval, in accordance with the 2010 Biologics Price Competition and Innovation Act (BPCIA).

There is a chance, however, that the drug could be available sooner, depending on a Supreme Court decision in Sandoz Inc. v. Amgen Inc. The court is set to hear arguments Wednesday on when a biosimilar sponsor can serve the innovator with the 180-day notice of commercial marketing required by the BPCIA. Its decision likely will be handed down in June.

The U.S. Court of Appeals for the Federal Circuit ruled in July 2015 that the BPCIA requires the marketing notice to be sent after a biosimilar is approved, regardless of whether the biosimilar sponsor followed the intricate "patent dance" detailed in the law. That dance between the biosimilar sponsor and the innovator consists of a time-limited exchange of the sponsor's biosimilar application, manufacturing information and potential patents that could be infringed. (See BioWorld Today, July 22, 2015.)

Sandoz appealed the Federal Circuit decision, maintaining that delaying the marketing notice until after approval is unnecessary if the biosimilar sponsor chooses not to follow the BPCIA patent dance and that the delay grants the innovator an extra six months of exclusivity.

In addition to the timing of the marketing notice, the Supreme Court will consider the Federal Circuit's ruling that the patent dance is optional for biosimilar sponsors. Amgen appealed that part of the ruling, arguing that the BPCIA makes the dance a requirement, because without the information exchange, the innovator might not know whether a biosimilar infringed certain patents.

U.S. a crucial market

A Supreme Court ruling favorable for biosimilar makers such as Samsung would have major implications for the U.S. market.

Theoretically, Samsung's product would be able to launch soon thereafter, competing with Inflectra, which Pfizer markets in the U.S. under a licensing deal with another South Korean firm, Celltrion Inc.

Johnson & Johnson, Janssen's parent company, predicted earlier this year in its 2016 report a 10 percent to 15 percent erosion in sales of Remicade, which, in 2016 recorded sales of $4.45 billion.

Sales in the first quarter of 2017 suggest that forecast was accurate. In the first quarter, worldwide sales of Remicade dropped 6 percent to $1.67 billion, while sales in the U.S. fell 2.4 percent to $1.8 billion.

Although Remicade has been competing with Inflectra in the U.S. only since late November, it has had to contend with biosimilar competition in the EU for a few years. The EMA approved Celltrion's Remsima/Inflectra in September 2013 and Samsung's biosimilar, marketed as Flixabi, in the EU, last May. By the first quarter of 2016, Celltrion's biosimilar had captured 24 percent of the EU infliximab market. However, on a global scale, the U.S. accounts for more than half of infliximab global sales, making it a crucial market for biosimilars, according to Celltrion.

For its part, Celltrion is aiming to generate $753 million in revenue and $433.55 million in operating profit in 2017.

Samsung Bioepis' BLA for Renflexis was based on phase I and phase III studies that tested its biosimilarity to Remicade. In a 54-week phase III study, Renflexis showed comparable safety and equivalent efficacy to Remicade, as evidenced in ACR20 response rate of 65.3 percent in the Renflexis arm vs. 69.2 percent in the Remicade arm at week 54, fully supporting the 30-week study results of 64.1 percent and 66 percent, respectively.

The Renflexis study randomized 584 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy across 73 sites in 11 countries.

The global biologics market is anticipated to be worth $399.5 billion by 2025, according to a new report by Grand View Research Inc., a U.S.-based market research and consulting company.

Regulatory Editor Mari Serebrov contributed to this article.