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.

LONDON (Reuters) – The new head of Europe’s drugs watchdog said on Friday there was an acute need to tighten regulations on medical devices, adding to pressure for radical change in the wake of a global scandal over French-made breast implants.

“I see an urgent need to regulate devices at the same level of science and attention as with drugs,” Guido Rasi, executive director the European Medicines Agency, told Reuters.

Medical devices are currently regulated in the European Union under the same “CE mark” scheme that is used for household appliances such as electric toasters, a notably relaxed regime that has been criticised by doctors.

In contrast to prescription medicines, devices need only a simple quality certification before being sold to the public.

Growing concerns about breast implants made by the now-defunct French company Poly Implant Prothese have focused attention on regulation and could accelerate changes to rules governing the medical technology sector.

“This might speed up some decisions,” Rasi, who took over as head of the London-based EMA in November, said in his first published interview.

New proposals from the European Commission on regulating devices, including measures for more pre-market testing and post-marketing surveillance, are set to go before EU ministers later this year.

LONDON (Reuters) – The new head of Europe’s drugs watchdog said on Friday there was an acute need to tighten regulations on medical devices, adding to pressure for radical change in the wake of a global scandal over French-made breast implants.

“I see an urgent need to regulate devices at the same level of science and attention as with drugs,” Guido Rasi, executive director the European Medicines Agency (EMA), told Reuters.

Medical devices are currently regulated in the European Union under the same “CE mark” scheme that is used for household appliances such as electric toasters, a notably relaxed regime that has been criticized by doctors.

In contrast to prescription medicines, devices need only a simple quality certification before being sold to the public.

Growing concerns about breast implants made by the now-defunct French company Poly Implant Prothese (PIP) have focused attention on regulation and could accelerate changes to rules governing the medical technology sector.

“This might speed up some decisions,” Rasi, who took over as head of the London-based EMA in November, said in his first published interview.

New proposals from the European Commission on regulating devices, including measures for more pre-market testing and post-marketing surveillance, are set to go before EU ministers later this year.

LONDON, Jan 6 (Reuters) – An international group of 25 doctors demanded on Friday that U.S.-based Hospira take action to prevent its muscle relaxant drug pancuronium being used for executions in the United States.

There has been controversy about using prescription medicines for lethal injections in the last two years, and campaigners have succeeded in curbing supplies of some products, causing drug shortages that have slowed U.S. executions.

Hospira stopped making another drug, thiopental, last January, and Denmark’s Lundbeck later restricted distribution of pentobarbital, which U.S. states that carry out the death penalty switched to when thiopental was not available.

Hospira, however, has not curbed supplies of pancuronium – a decision consultant neurologist David Nicholl of Birmingham’s City Hospital, England, and colleagues said was out of line with its corporate commitment to be “an ethical global citizen”.

“It is time for Hospira to live up to those fine words, without affecting patients’ care, by putting in place a restricted distribution system for pancuronium,” they wrote in an open letter to The Lancet medical journal.

Nicholl and other doctors from Britain, Italy, Ireland, India, Australia and Saudi Arabia said there was a very real possibility that pancuronium, when used for executions, could cause extreme pain and suffering in a paralysed prisoner.

Hospira, the sole supplier of the medicine, said it had regularly written to U.S. states making clear its opposition to use of its drugs in executions.