Stricter controls on biotech copies branded ‘unnecessary’

Date:24/07/03

The regulation of duplicated biopharmaceuticals is proving to be a contentious issue, writes Karen Carstens

NEW battle lines have been drawn in the debate over a sweeping overhaul of EU pharmaceuticals policy between two warring factions contesting how to handle generic copies of cutting-edge medicines called biopharmaceuticals.

Made using biological substances as opposed to chemicals, these promise hitherto undreamed of breakthroughs in treating - possibly even curing - cancers and degenerative diseases such as Alzheimer's. Biotech treatments, however, are in a fledgling stage, with a first batch of products having just begun their hopefully long and illustrious curative careers.

It is estimated that up to 50% of products now in the pharma industry pipeline are biomedicines, many of them being developed by highly specialized small- and medium-sized businesses, as well as major players such as Pfizer and Johnson & Johnson. Collectively represented as a separate group within the European Federation of Pharmaceutical Industries and Associations (EFPIA) called Emerging Biopharmaceutical Enterprises (EBE), they make up the first of two parties that have a decidedly different view of how to handle copies of these modern medicines. The second is the generics industry itself, represented by the European Generics Association (EGA), along with other groups.

The EGA claims that the EBE and EFPIA are trying to change the rules of the medical approvals game to keep less expensive biogenerics or "biosimilars" - generic versions of the original brand-name biomedicines - off the market for as long as possible by pressing for EU legislation that would needlessly overburden generics companies with unnecessary testing requirements.

But the EBE says that biosimilars must be strictly regulated, at least until the science behind them is further advanced, because they behave differently from traditional, chemicals-based medicines.

The trouble began last autumn, when two amendments on biosimilars were tacked onto a first European Parliament reading of a massive pharmaceuticals review package, comprised of three separate laws that will dominate Europe's medical landscape for a decade after entering into force, probably in 2004.

Tabled by French MEP Françoise Grossetête, rapporteur for a key proposal on human medicines, they seek to introduce highly technical definitions of biosimilars and how they should be approved into the new EU rules.

The Grossetête amendments will be hotly debated in the run-up to a second reading of the pharmaceuticals package, due to take place by the end of the year.

The EBE argues that, given that the first patents for biomedicines will soon expire and there are "currently no definitive regulatory requirements for biosimilars", the pharmaceuticals review is an "opportunity to prepare for the future" that cannot be missed. "The criteria currently used to approve [chemical] "generic products" are inappropriate for similar biological medicinal products," the EBE cautions.

But Greg Perry, the EGA's director-general, begs to differ.

"Everyone agrees that these biogeneric products will require extra information and extra clinical trials," he said. "But that doesn't mean it's necessary to repeat all trials...they would want us to have trials on animals and humans that are not necessary and produce costs that are not necessary."

According to Perry, "the scientific opinion is not on their side" and "they're really just trying to confuse the issue" in a clear case of MEPs being lobbied by big businesses attempting to protect their precious patents and keep competitors off their turf. "This is a repeat of the same kinds of things they were saying 15 years ago when generics first hit the European market," he added.

Perry said scientists at the London-based European Agency for the Evaluation of Medicinal Products had already agreed that biogenerics would be treated on an individual, case-by-case basis. This was the same broad approach supported by the European Commission, which did not seek to define and regulate biosimilars in its original February 2001 proposal, and by member states, he added.

But the EBE argues there would still be such room for differentiation under the new, biosimilar approvals system they back, with simpler biomedicines based on smaller molecules - such as insulin - requiring fewer tests and more complex compounds based on bigger molecules - such as interferon (used to treat multiple sclerosis).

Moreover, EBE experts warn, the need for strict regulation of biosimilars really is acute because if something goes wrong with a biomedicine, it can go horribly wrong, leading to an acute "immune reaction" whereby the human system tries to fight and reject the foreign "invader" rather than absorb it as a good and healing "helper".

Perry, however, warned that if MEPs seriously pursue the Grossetête amendments, the whole pharma package "will end up in conciliation", further stalling its final adoption.

Analysis of the debate surrounding the regulation of duplicated biopharmaceuticals.