Biosimilar copies of blockbuster drug launch in major EU markets

Reuters Health Information: Biosimilar copies of blockbuster drug launch in major EU markets

Biosimilar copies of blockbuster drug launch in major EU markets

Last Updated: 2015-02-25

By Ben Hirschler

LONDON (Reuters) - Cheap versions of a top-selling drug for rheumatoid arthritis and Crohn's disease are being launched across major European markets in an important advance for biosimilar drugs.

The products from South Korean firm Celltrion and its partners Hospira and Mundipharma will compete with Remicade (infliximab), the original branded drug from Johnson & Johnson and Merck & Co.

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.

Unlisted Mundipharma said on Wednesday that it is launching its biosimilar Remsima in Germany, Italy, Britain, the Netherlands, Belgium and Luxembourg, following expiry of relevant Remicade patents.

Hospira is to sell its product Inflectra in markets including Austria, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Spain and Sweden.

Copies of Remicade have been on sale for several months in some smaller European markets, such as Norway, but the move into major economies is a big step forward for products that could disrupt the multibillion-dollar biotechnology industry.

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.

Remicade, which has annual European sales of about 2 billion euros ($2.3 billion), and the two biosimilar copies all contain infliximab.

There has been a fierce debate for many years on how rapidly biosimilars will be adopted by doctors and the take-up of Remsima and Inflectra in the likes of Germany, France and Britain will be an important test.

Many more biosimilar copies of drugs for diseases ranging from cancer to eye disorders are now in development, posing a threat to leading biotech drugmakers such as Roche and AbbVie.

Citigroup analyst Andrew Baum 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.

The upside for society is that they could generate an estimated $50 billion in savings for healthcare systems, Citi says.

Jorgen Jahnsen, professor of medicine and gastroenterology at the University of Oslo, said that in Norway the use of biosimilar infliximab had already enabled the healthcare system to make considerable savings.

Another test for biosimilars is looming in the United States, where a Food and Drug Administration advisory committee will decide on March 17 whether to recommend Celltrion's biosimilar version of Remicade.

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