Automatic substitution of biosimilars banned in 15 European countries, says EGA

Fifteen countries across Europe have brought in new rules to prevent the automatic substitution of biological medicines by biosimilars, according to the European Generics Association (EGA).

The changes follow advice from the EMEA in June 2007 that biosimilars cannot be considered identical to their biological reference products and the decision to treat a patient with either should be made by a qualified healthcare professional.

However, the agency confirmed that decisions on the use of the products were not its responsibility and the policy should be made at local level.

Thomas Bols, Amgen's head of regulatory affairs in Europe, said that France, Spain, the UK, the Netherlands and Sweden were among the countries that had brought in new rules or issued new guidelines about prescribing biosimilars by brand name and recommending against automatic substitution.

However, Bols argued that more information for prescribers was needed. "Overall, healthcare professionals are not so much used to dealing with biotech drugs," he said, although in certain quarters, awareness of biosimilars was growing.

He denied branded pharmaceutical companies were 'scaremongering' over the risks of switching branded biologicals for biosimilars (and vice versa). He said Amgen had learnt from experience that small changes to biological products could have a dramatic impact on patients, such as the side effect of pure red-cell aplasia with Johnson & Johnson's anaemia drug Eprex (epoetin alfa) after a manufacturing change.

He added that it might never be possible for generic manufacturers to come up with a copy of monoclonal antibody drugs, of which Amgen has several in its pipeline, and certainly not in the next five to 10 years.

Meanwhile Warwick Smith, director of the British Generic Manufacturers Association (BGMA) criticised a recent Amgen-funded UK parliamentary report that recommended brand name prescribing of biopharmaceuticals and an "urgent ban" on substitution.

Some pharma companies had been talking about potential safety concerns with biosimilars but this was just "scaremongering to protect their market", he said.

Despite this, Smith said prescribing by brand name was the right approach. "It is just as important to maintain pharmacovigilance with original biologicals as with biosimilars. The science is at such a stage that it's an appropriate measure." However, the BGMA's view on this could change with clinical data, he said. "We need to see what experience brings."

The debate over biosimilars is also heating up in the US, with a new report suggesting they could bring cost savings of US$378bn (Euro 256 bn) in the next 20 years. The report, by economist Dr Robert Shapiro, was commissioned by biotech company Insmed, which hopes to take its follow-on biologicals into the clinical trials this year.

In addition, media reports suggest that the Californian Democrat senator Anna Eshoo plans to submit a bill to congress that proposes a pathway for approval of biosimilar medicines - or biogenerics as the bill will call them - by the FDA.

Many manufacturers in the US are said to be frustrated by the slow pace of legislative change needed to bring biosimilars to the market.