FDA approves biosimilar to J&J's Remicade for multiple diseases

[April 06, 2016]  (Reuters) - The U.S. Food and Drug Administration (FDA) on Tuesday approved Inflectra, a cheaper version of Johnson & Johnson's drug Remicade, to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriasis and arthritis of the spine.

Inflectra, made by South Korea's Celltrion Inc in partnership with Pfizer Inc's Hospira unit, was the second biosimilar approved by the FDA.

Celltrion chief executive Kim Hyoung-ki told reporters on Wednesday that Inflectra is expected to be priced about 20 to 30 percent lower than Remicade in the U.S. market, but the final price would need to be decided after discussions with partner Pfizer.

Remicade generated annual worldwide sales of $6.5 billion. Of that, $4.5 billion were in the United States. Merck & Co sells Remicade in Europe. Celltrion sells the biosimilar overseas under the brand Remsima.
 

Celltrion said in a statement Inflectra gained more than 20 percent share of the Remicade market in terms of patient numbers in European countries where the copy is sold as of December 2015. The drug was approved by European regulators in 2013 and began sales in Europe's largest countries in February 2015.

A year ago, the FDA approved the first biosimilar - Novartis AG's Zarxio, which is similar to Amgen Inc's white blood cell-boosting drug, Neupogen.

Remicade and Neupogen are biologic drugs made from living organisms. Copies of biologic products cannot easily be replicated and are known as biosimilar, not generic, because they are similar, not identical, to the original.

Remicade, as well as similar drugs made by AbbVie Inc and Amgen Inc, work by blocking an inflammation-causing protein called Tumor Necrosis Factor, or TNF. Dozens of anti-TNF biosimilars are in development.

Celltrion said its biosimilar version of Roche's breast cancer biotech drug Herceptin expects to apply for global approval in the second half of this year, and its copy of Roche's non-Hodgkin's lymphoma biotech drug Rituxan, also called MabThera, is currently awaiting European approval after applying in October.

Shares in Celltrion were down 5.6 percent as of 0353 GMT, compared to a 0.4 percent gain in the wider market. Analysts said the shares pulled back after gaining about 20 percent in the run-up to the widely expected approval after an FDA panel backed Inflectra in February.

(Reporting by Rosmi Shaji in Bengaluru and Joyce Lee in SEOUL; Editing by Peter Cooney and Muralikumar Anantharaman) 

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