Biotech start-ups warned of lengthening US approval process

Biotech start-ups looking to go stateside have been warned to prepare for a long, drawn-out process, following reports the US Food and Drug Administration has become more conservative with its approvals.

Frank Glatz, managing director of Melbourne-based company Cardia Bioplastics, says biotech start-ups shouldn’t expect “any forgiveness” from the US regulator.

“It takes much longer [to receive FDA approval than it used to] and therefore you need a very good kind of offering,” Glatz says.

His comments come on the back of a report by The Australian Financial Review, which suggests the FDA has taken a tighter approach in recent months.

“Speculation about the actions and attitudes of the US Food and Drug Administration has increased since June after the FDA did not… approve a pain formulation from ASX-listed QRxPharma,” its report said.

Cardia Bioplastics, a leader in sustainable and renewable bioplastics technology, recently signed a deal with the US-based Sealed Air Corporation to provide the resin for its inflatable packaging.

Meanwhile, an undisclosed multinational consumer goods company has commenced in-market validation of its personal care products packaging, also made from Cardia’s resin technology.

With manufacturing operations in China, Cardia Bioplastics has offices and distributors in Europe, the United States, South America and South East Asia.

“The American market is particularly interesting for us because it is very concerned about the use of finite resources such as oil,” Glatz says.

“We’re working with one of the biggest consumer brands in the world on consumer packaging, and the FDA is all over that.”

“What I can say is getting approval from the FDA for food packaging is very, very demanding. It’s a long process but… we experience a similar situation in Europe.”

“Is it a slow process? Absolutely. But that seems to be the norm.”

According to Glatz, anything that used to take a year to get approved could now take two years or longer, and the FDA is “an important part of that process”.

“Bringing new technology to the market has become much more stringent for all us start-up companies,” he says.

“As a start-up company, you don’t get any forgiveness… so you have to put a lot of effort in to get the same performance [as your competitors].”

“Your pricing point has to be so good. If you don’t think you can achieve it, don’t get engaged because you won’t be successful.”

“It’s a tough and long process, so you need a really differentiated offer.”