Complex biogenerics seen inevitable, but distant

By Tom Armitage

LONDON (Reuters) - Generic versions of complex biotech medicines are inevitable but they may be a decade away, industry executives said this week, as the first copycat versions of simple biotech drugs near the European market.

Cut-price versions of the oldest biological medicines, such as growth hormone or insulin, look set to start replacing their branded cousins as early as this year in Europe.

However, executives from biotech companies told the Reuters Biotechnology Summit that harder-to-make treatments for cancer or autoimmune diseases such as rheumatoid arthritis would be free of generic competition for years to come.

"I think it is a least 10 years away," Lisa Drakeman, chief executive of Danish antibody firm Genmab (GEN.CO: Quote, Profile, Research, Stock Buzz), told the summit in London.

"Biologics require special care in manufacturing, so it's going to be a very long time before people are able to duplicate them in such a way that regulatory authorities are going to say this is an identical product," she said.

Sandoz, the generics drug division of Novartis AG (NOVN.VX: Quote, Profile, Research, Stock Buzz), has spearheaded a campaign to get biogenerics -- or biosimilars as they are more accurately described -- to the market.

It finally succeeded last month in winning a positive EU opinion for its Omnitrope generic growth hormone following a lengthy battle with regulators.

BioPartners also got a positive opinion for another similar growth hormone on Thursday.  Continued...