FDA postpones key hearing on biosimilar copy of blockbuster drug

[February 26, 2015] By Ben Hirschler

(Reuters) - The U.S. Food and Drug Administration has postponed a crucial meeting of an advisory committee to consider a cheap version of a top-selling drug for rheumatoid arthritis and Crohn's disease, which had been scheduled for March 17.

The U.S. regulator said in a statement on its website late on Wednesday that the hearing was postponed "due to information requests pending with the sponsor of the application".

South Korean firm Celltrion and its partner Hospira want to sell Remsima in the United States as a cut-price copy of Johnson & Johnson and Merck & Co's branded drug Remicade.

Copies of the drug, which contain the antibody infliximab, have been launched in recent days in major European markets.

The U.S. panel hearing is another major milestone in the advance of for the new type of medicines known as biosimilars, since a positive recommendation would pave the way for Remsima's launch in the world's biggest market.

The FDA said a future meeting date would be announced in due course.

Citigroup analyst Andrew Baum said the delay appeared procedural and it was unlikely there were major issues over the clinical data supporting the product, given that Remsima has already been approved in Europe, Japan and Canada.

Remsima is seen as a litmus test for the acceptance of biosimilar versions of antibody drugs, which are among some of the world's biggest-selling medicines and are used for diseases ranging from cancer to eye disorders.

Remicade had worldwide sales last year of more than $9 billion.

The potential of biosimilars to grab substantial business from original brands was a key factor behind Pfizer’s decision this month to buy Hospira for about $15 billion.

Because biotech drugs are made from living cells it is impossible to manufacture exact copies, as happens with simple chemical medicines, so regulators have come up with the notion of approving products that are similar enough to do the job.

Citigroup predicted this month that biosimilars would result in at least $110 billion of value being transferred from innovator companies to copycat producers between 2015 and 2025.

(Editing by Greg Mahlich)

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