South Korea's Celltrion gets U.S. FDA nod for Remicade biosimilar Inflectra

Starting blocks

The hits keep coming for South Korean biosimilar makers with Incheon-based Celltrion snapping up a U.S. FDA approval for a biosimilar of Johnson & Johnson's ($JNJ) Remicade (infliximab), which follows crosstown rival Samsung Bioepis getting an endorsement from the EMA for its version of the drug, Flixabi. 

The Celltrion intravenously administered version of the rheumatoid arthritis drug will be sold as Inflectra (infliximab-dyyb). The FDA noted that it's the second biosimilar it's approved after Novartis' ($NVS) Sandoz unit won approval last year for Zarxio, a biosimilar of Amgen's ($AMGN) Neupogen (filgrastim).

Of note however is how quickly manufacturing operations in South Korea have been established to speed biosimilars to market approval. Celltrion has been selling a Remicade biosimilar in Europe since 2015 under the name Inflectra as part of a marketing pact with Hospira, now owned by Pfizer ($PFE).

The company is also pursuing approvals for a biosimilar of Roche's ($RHBBY) Herceptin (trastuzumab) and in November last year submitted a biosimilar approval application to the European Medicines Agency for Roche's rituximab (Rituxan/Mabthera). The drug went off patent in Europe in 2013 and will lose patent protection in the United States this year.

Incheon-based Samsung Bioepis with Biogen ($BIIB) brought Europe's first biosimilar approval in four years for a biosim of Amgen and Pfizer's blockbuster Enbrel (etanercept).

That represents 1 of 6 biosimilar candidates either approved in regulated markets or in development on the regulatory pathway, including biosims for Remicade, Lantus (insulin glargine), Humira (adalimumab), Herceptin and Avastin (bevacizumab)--with another 7 molecules at early stages.

The FDA stamp on the Remicade biosimilar was explicit on safety as well.

"Biosimilars can provide access to important treatment options for patients who need them," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement.

"Patients and the health care community can be confident that biosimilar products are high quality and meet the agency's rigorous scientific standards."

Though there was a caveat that Johnson & Johnson has stressed in its own comments on biosimilars of Remicade, which is marketed by its Janssen Biotech unit: "Inflectra has been approved as biosimilar, not as an interchangeable product," the FDA statement said.

As well, Inflectra remains part of legal cases related to the U.S. Biologics Price Competition and Innovation Act for certain Remicade patents held by Johnson & Johnson that extend beyond the main expiry at the end of June. A similar challenge led to a 6-month delay in product sales launch in the case of Zarxio.

- here's the FDA release