U.S. FDA accepts Samsung Bioepis infliximab biosim for review

FDA sign

Incheon-based Samsung Bioepis said the U.S. FDA has accepted its biosimilar candidate of Johnson & Johnson's ($JNJ) blockbuster Remicade (infliximab) for approval review--making it the second South Korean company set to enter the U.S. market in the space where the originator company plans to fight back even as a partner joins in.

The candidate, dubbed SB2, won a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in April as Flixabi and awaits European Commission approval, which should be granted this quarter. It is now sold in Korea as Renflexis.

"SB2 is the first Samsung Bioepis biosimilar candidate submitted for review in the United States," Samsung Bioepis, a joint venture between majority partner South Korea's Samsung Biologics and Biogen ($BIIB), said in a release.

"If approved, the marketing and distribution of SB2 in the U.S. will be handled by Merck, in accordance with a commercialization agreement signed in 2013."

An approval would set up proxy battles involving leading U.S. drugmakers and the South Korean upstarts, as well as other players, akin to musical chairs. Merck ($MRK) holds the commercial rights to sell Remicade in Europe, Turkey and Russia in an agreement with its developer, the Janssen drug unit of Johnson & Johnson.

As well, Orion Oyj sells Remsima for Celltrion in Scandinavia and Mundipharma has launched its own version in Europe. In India, Boston-based Epirus Biopharmaceuticals and Ranbaxy Laboratories--now owned by India's Sun Pharmaceutical--partnered at the end of 2014 to sell a version manufactured by Reliance Life Science.

In April, South Korea's Celltrion won a U.S. FDA nod for a biosimilar of Remicade, called Remsima, that will be marketed by Pfizer's ($PFE) Hospira unit, which has rights in the U.S. On the first-quarter earnings call, a Pfizer executive cautiously said the launch is a go for this year, as early as June 30.

But for the same quarter Johnson & Johnson's CFO Dominic Caruso was emphatic that a biosimilar of Remicade will not be launched in the U.S. this year. The therapy is part of legal cases related to the U.S. Biologics Price Competition and Innovation Act. A similar challenge led to a 6-month delay in product sales launch in the case of Novartis' ($NVS) Zarxio (filgrastim-sndz), a copycat of Amgen's ($AMGN) Neupogen.

SB2 is one of 6 biosimilar candidates either approved in regulated markets for Samsung Bioepis such as Enbrel (etanercept) or in development on the regulatory pathway that include Remicade, Sanofi's ($SNY) blockbuster insulin Lantus (insulin glargine), AbbVie's ($ABBV) autoimmune treatment Humira (adalimumab), Roche's ($RHHBY) breast cancer drug Herceptin (trastuzumab) and its multicancer drug Avastin (bevacizumab)--with another 7 molecules at early stages.

Also in April, the tussle over biosimilar versions of blockbuster drugs saw Samsung Bioepis aim a U.K. lawsuit at AbbVie's Humira patents; Humira is currently the biggest-selling drug in the world with $14 billion in sales expected this year.

“At Samsung Bioepis, we are dedicated to bringing affordable, high-quality biologic medicines to patients across the United States," said Christopher Hansung Ko, president and CEO of Samsung Bioepis, in a statement.

"Already in other countries, our biosimilars have started to play an important role in increasing patient access to high-quality treatment options, while driving down healthcare expenditures. We hope to do the same in the U.S."

- here's the Samsung Bioepis website
- and the release from Merck