Copycat versions of some of the biggest-selling drugs in the world could hit Europe this year, according to new research from independent market research organisation Datamonitor, which says the region’s drug authorities are making significant strides in forging a regulatory pathway that will enable cheaper copies of biotechnology medicines available on the market.

However, says Datamonitor, the USA is lagging behind with the first biogenerics not expected to reach its shores until 2009.

Global sales of biologic drugs, such as insulin (diabetes), human growth factor (growth deficiencies), epoetin (anaemia), interferon alfa and beta (hepatitis C and multiple sclerosis), reached in excess of $56 billion in 2004, a sharp increase of 18% over the previous year. Such big earners makes it an attractive market for generics companies, although they have had to overcome major challenges in terms of huge development costs and more stringent quality testing – as well as uncertain regulatory processes. Biologic products with sales of $20 billion in 2004 are at immediate risk of generic erosion.

The European Union, in particular, has helped ease the path for biogenerics and, in 2003, created a legal framework for biogenerics, publishing several draft guidelines, including specific clinical and non-clinical data requirements for four products types: insulin, human growth hormone factor, epoetin and colony stimulating factors.

Final guidelines and first product approvals could come as soon as this year and the European Medicines Agency (EMEA) last month reportedly said that it expected to receive eight marketing applications for biogenerics this year.

The USA tells a different story, though, with Datamonitor anticipating a “long and winding road to biogenerics.” Congress has yet to create any legislation for approving such medicines and instead appears “ to be waiting for guidance from lawmakers.”

“All in all, generics companies will have to create an entirely new business model for biogenerics: in many ways close to the branded biotech model,” explains Datamonitor.

And which firms does it believe will be key players? Novartis’ generics unit Sandoz, Teva Pharmaceuticals, BioPartners, Ratiopharm and Stada Arzneimittell AG are all tipped for the top, but success won’t necessarily come easily. Datamonitor concludes: “The feeling is that we have not yet even seen the start of the key confrontations in biogenerics. But, as biogeneric products approach the market, the real battles will begin.”