The Hindu Business Line : US FDA to adopt collaborative approach for biosimilar imports

Hyderabad, Jan. 10 The US Food and Drug Administration is planning to adopt a collaborative approach to put in place the regulatory framework for import of biosimilars into the US. It would work hand in hand with the producers of biosimilars to work out a case-based approval mechanism.

“Due to the very diversified scientific portfolio of biosimilars we prefer to have a regulatory framework by working together with the manufacturers of biosimilars across the world, including India,” Mr Andrew C. von Eschenbach, Commissioner, US FDA, told newspersons at the Innovation Plaza of Dr Reddy’s Laboratories here recently.

Mr Michael O. Leavitt, Secretary of Health and Human Services, US Department of Health and Human Services, said ensuring quality of imports into the US had been a priority area for US.

“In the recent years, we have seen many instances where the quality of a product became questionable. Goods worth $2 trillion, manufactured by 800,000 non-US manufacturers, are being imported from 300 points every year. This has resulted in a basic change in our approach to imports,” he said.

Instead of physical inspection of imported products, the US was now keen on building quality in manufacturing process of products being imported. “As part of this, we are visiting many places across the world to work together in regulatory practices,” the US official said.

On the reported delays in granting approvals for Indian drug products, he said there was “no change in any of the practices being followed by FDA in clearing the products” that could result in delay in approvals.

The US would prefer transparency in product processes and development of common standards, he added.

Dr Reddy’s forging major deal

Dr K. Anji Reddy, founder-Chairman of Dr Reddy’s Laboratories, said the company would be forging a deal with an “American company”, the details of which would be announced in the last week of this month.

“We are able to capture a major share of generics market in the world. We would like to become the biggest generics suppliers in the world,” he said.

Mr G.V. Prasad, Vice-Chairman and CEO, Dr Reddy’s, said biosimilars would be the focus area. The Hyderabad-based company now has two biosimilars in the market and eight products in the pipeline. “Biosimilar journey is not a clear one yet. But we are working on registrations in various geographies,” he added.

On the visit of the US officials, Mr Prasad said it was an “exploratory” visit and no specific issues had been taken up by both the parties.