LONDON, July 21 (APM) - The EMEA "will not guarantee" that biosimilars are interchangeable with their originators and the decision will have be made elsewhere, probably at national level, European Medicines Agency (EMEA) Executive Director Thomas Lonngren said on Friday.

a move likely to please the branded industry and disappoint generic manufacturers in equal measures, Lonngren told APM in an interview: "It is not possible we would guarantee a biosimilar is interchangeable (with its originator).

"We make this guarantee with generics, but with two identical molecules we can say these molecules will behave in an identical way."

Lonngren conceded that the EMEA's scientists were probably best placed to decide if a biosimilar was close enough to its originator to be dispensed in its place but this decision remained outside of the EMEA's remit.

Although he was always against the EMEA taking on the role, under pressure from representatives of the generic industry at a meeting in London in May he said he would see how the issue may be taken forward.

However, a couple of months on he is now firm in his "no" to the EMEA deciding when biosimilars can safely replace an original at the point of dispensing. Furthermore the precedent for local decision making in the use of biologicals was already set, he added.

"Before we had the possibility for biosimilars ... local health systems made the decision between different brands of biological products.

"This has never been a regulatory decision. (The decision) is based on clinical experience that you could switch one drug but you could not switch another because patients reacted in different ways."

WHO TO TRY TO SORT OUR INNS FOR BIOGENERICS

Lonngren was speaking ahead of meeting organised by the World Health Organisation which will attempt to sort out the issue of International Non-proprietary Names (INN) for biosimilars.

The EMEA will be sending experts to the meeting in December but Lonngren was keen to point out it is the WHO that grants INNs and this is a decision based on marketing and other criteria, not science.

It does not have the scientific expertise to decide when a biosimilar is close enough to its originator to carry the same INN - i.e. simvastatin in the case of Merck and Co's Zocor.

The generics industry is lobbying hard against any stance which will make it difficult for biosimilars to carry the INN of their originators.

It sees this as an artificial barrier being erected to stop biogenerics routinely being used to replace their originators.

Based on the fact that the WHO cannot make the decision if its safe to switch between brand and copy, and so decide on if a new INN could or should be granted, the European Generic Medicines Association (EGA) has previously called on the EMEA to make that decision for the EU.

BIG BIOSIMILAR MARKET BUT BIG BARRIERS

The EGA has noted that some $6.7 billion worth of presently patented biologicals will lose protection in the next three to five years.

However it is not only the issue of interchangability that stands between the copycat medicines and a big share of this.

Analysts have pointed out that, for example, human growth hormone is already a fragmented market and large amounts of efficacy data will be needed before interchangability between biological original and copy will be possible - even if anybody is prepared to take on the decision making role.

Nor do biosimilars enjoy the large price advantage than generic enjoy, because of high production costs they cost around 70% of the original.

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[3250] 21/07/2006 04:00 GMT - INDUSTRY