India, China see potential in biosimilars as US stalls on legislation

With the passage of new patent laws in their countries, India and China will be well-poised to accelerate their pharmaceutical industries, especially biopharmaceuticals, says the author of a new research study of emerging non-US pharmaceutical markets.

According to Kalorama Information’s new report Pharmaceutical Markets in Brazil, Russia, India and China (BRIC nations), companies in India and China are placing themselves in a good position to compete worldwide with developers of innovative biological products.

Pharmaceutical markets in China and India reached $20.5 billion in 2007 and are expected to double over the next five years. Ranked seventh and thirteenth in the world respectively, they will probably move up quickly in ranking as incomes, standards of living and healthcare education efforts increase.

Products competing with brand name biopharmaceuticals will be one of the key drivers of growth.

“India and China are home to several companies developing biosimilars and these companies are in a good position to continue development as doors are expected to open more around the world,” notes Kalorama Information analyst Melissa Elder.

“Companies like Dr. Reddy’s Laboratories already have multiple biosimilars approved in-country and have reported looking to new markets.”

The US and Europe have provided protection from generic competition for biological products, but looming patent expirations and new laws are creating excitement for generic drug developers.

Europe now has regulations concerning the development and launch of biosimilars but the U.S. is behind in this area. For example, Sandoz submitted an application for a biosimilar in 2003 and ended up suing the FDA for not giving them a response for several years.

“To date, the US does not have rules and regulations in place, although in 2007 legislation was proposed under the Biologics Price Competition and Innovation Act,” notes Elder. “It attempts to strike a balance between market competition and reimbursement for innovators.”