Biotech firms prepare for battle over copycat drugs

Date: 20/07/05

Pharmaceutical companies are trying to meet the demands of shareholders and patients while reconciling social responsibility with the need for healthy balance sheets. Can Europe keep regulation, innovation and profit in balance? Anna McLauchlin reports Giant biotechnology companies are heading for a battle with their generic counterparts over copies of biologic drugs - biosimilars - whose patents have expired in Europe or will expire shortly. The US is watching the situation closely as, unusually, it is Europe that will set the stage in the global arena for biosimilars.

Biologic medicines are produced using a living organism to create a protein that is then formulated as a therapeutic drug. The manufacturing process is as important as the original organism and one tiny change in this process can significantly change the properties of the final medicine.

Several biologics are already on the market, including anti-anaemic medicine, treatment for multiple sclerosis and cystic fibrosis and growth hormone drugs, and many are about to come out of patent protection this year or in 2006. The patent has already expired on the anti-anaemic treatment known as EPO, which caused controversy after being used by athletes to increase their red blood count.

But because of their nature, no two companies are able to manufacture two identical biologics, which has raised problems for companies wanting to make biosimilars. As a result, the European Commission, via its European Medicines Agency, will release guidelines stating how much pre-clinical (using animals) and clinical (using humans) testing has to be carried out for a biosimilar to be approved on a case-by-case basis.

The agency released a first draft of guidelines for consultation on 16 June. The deadline for comments is the end of October, with the final text expected in the first quarter of 2006. Big manufacturers such as Roche (Switzerland) and Amgen (US) are fighting with big generic firms including Sandoz and Teva over how strict the rules should be.

Generic firms argue that the industry is trying to raise the bar unnecessarily high in order to deter them from making biosimilars. Manufacturing biologics can be extremely costly, with a complex process that may only produce a small amount of product, and if generic firms have to carry out costly testing as well, it may not be financially viable.

"We are aware that [the originator industry] use the ongoing scientific discussions in order to raise as much as possible the data requirements for approval of biosimilars," says Suzette Kox from the European Generics Association.

But industry sources argue that there are other issues at stake. Apart from safety, the industry is worried that vague guidelines will encourage companies to seek more advice from the European Medicines Agency, which will mean much of the process is carried out behind closed doors.

"Obviously industry's main goal is to make sure that products are safe," says one. "But there is also an economic reason. If there is no transparency, the industry is worried that its nascent business could face a public backlash like the one that has been seen over GMOs."

US companies are particularly concerned about the development of the European approval process for biosimilars as it will be forced to adopt similar ones in the future or face competition from Europe. Because biologic drugs were patented earlier in Europe than in the US, companies wanting to produce copies will have access to the market earlier than in the US.

The US biotech association - BIO - has already submitted its opinion on the draft agency guidelines, which calls for clinical trials for all biosimilars.

Article reports that the patents for many biological drugs - so called biosimilars - were to expire in 2005 or 2006. The European Commission, via its European Medicines Agency, was planning to release guidelines stating how much pre-clinical (using animals) and clinical (using humans) testing has to be carried out for a biosimilar to be approved on a case-by-case basis.

• Primary Source

EMEA: Human Medicines http://www.emea.europa.eu/index/indexh1.htm

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