Biotech versions: the next big thing?

In Europe they are called biosimilars and in US, FDA calls them follow on protein products but copies of biotech drugs could be the next big opportunity for Indian drug companies reports CNBC-TV18.

Rapidly rising healthcare costs in the US, lobbying by insurance companies and a strong pitch by generic companies like Sandoz could lead to the next big opportunity for Indian drug makers - that is copies of biotech drugs.

With Sandoz gaining access to the US and EU for marketing its growth hormone called Omnitrope, chances of regulatory approval for other biotech clones appear brighter now.

In fact, seven democrats have recently appealed to the US FDA for a policy framework to allow cheap copies of biotech drugs.

"We believe the US will have the hatch waxman legislation in place and then when the pathways are cleared we can do the product line up for registering this product in the US," says Pankaj Patel, CMD, Zydus Cadila.

The biotech market in the US is pegged at around 70 billion dollars and is growing above 20% annually. Though doubts are raised on safety and efficacy of copied biotech products, experts point out that it is not difficult to make identical biotech drugs.

"One of the basis to say no is that proteins cannot be copied but with tolls like microfuidics and on line analytics its within the limits of the possible of the product," says Ajaz S Hussain, VP & Global Head, Biopharma Development.

A host of Indian companies are already gearing up to grab the opportunity. While Wockhardt and Cadila are working on products like insulin and Erythropoetin, Ranbaxy has picked up a stake in Hyderabad based Zenotech labs to gain access to certain cancer treatment drugs. Dr Reddy 's has also lined up a few similar biotech products by all indications, in the next two to three years; cheap copies of biotech drugs could open up bigger business avenues for top Indian drugmakers.