January 6, 2012 / 2:30 PM / 8 years ago

EU to set new biosimilar drug rules by mid-year

LONDON (Reuters) - European regulators will detail the requirements for copies of multiple types of biotech drugs by mid-2012, setting the stage for increased generic competition in a multibillion-dollar market that includes products for cancer and modern insulins.

Guido Rasi, the new executive director of the European Medicines Agency (EMA), told Reuters on Friday the London-based watchdog would issue its final guideline on biosimilar monoclonal antibodies in March or April.

Draft guidelines on the approval process for copies of other drugs will follow in May or June. These will include low molecular weight heparin, such as Sanofi’s Lovenox or enoxaparin, and modern analogues of insulin.

Up to now, complex biotechnology medicines, which are given by injection, have been largely immune from generic competition, unlike conventional chemical pills and capsules.

But the regulatory landscape is starting to change, posing a threat to leading biotech groups such as Roche and Amgen, as well as makers of insulin, such as Novo Nordisk.

Europe has already approved some so-called biosimilars, including copycat versions of human growth hormone and the anemia treatment EPO. Antibodies, however, are a much bigger prize, since they include blockbuster treatments for diseases such as cancer and rheumatoid arthritis.

One of the first antibodies being targeted by generic drug companies is Roche’s cancer and arthritis treatment Rituxan, which loses patent protection in Europe at the end of 2013.

Rasi said he believed biosimilars would play an important role in future European healthcare, as cheaper alternatives to original branded products. But he noted that many drugmakers were at the same time developing next-generation versions of medicines which might limit the competition.

“I don’t really have concern about the level of safety (of biosimilars),” he said. “What is a question-mark is efficacy, since many biotechnology products are now being improved.”

Swiss-based Roche has been particularly active in developing “biobetter” drugs that it hopes will mitigate the biosimilar threat.

U.S. regulatory preparations for biosimilars are further behind than in Europe, but leading generic drugmakers — including Teva, Novartis unit Sandoz and Hospira — are eyeing opportunities in both markets.

Editing by David Holmes

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