What’s holding up biosimilars in the US? Researchers investigate

By Zachary Brennan

- Last updated on GMT

What’s holding up biosimilars in the US? Researchers investigate
Politics might not be the only obstacle in getting biosimilars approved in the US, though much of the rest of the world seems intent on obtaining approvals as fast as possible, according to a new report from research company Frost & Sullivan.

The beginning of a boom market for biosimilars begins with three main points, according to the report:

·     An untapped US market with a strong pipeline, as well as markets in Asia and Latin America, will be key growth opportunities because of the relatively low cost of manufacturing;

·     Significant mergers, acquisitions and alliances with companies with expertise in biosimilars or biotech companies and those in emerging markets that already manufacture biosimilars; and

·     The launch of innovative platforms to reduce the cost of biosimilar production, thus providing substantial price differentiation.

Europe, US

The EU has clearly taken the lead​ on approving biosimilars, as the region has 12 currently approved, including human growth hormone and erytropin, Srinivas Sashidhar – senior research analyst, life sciences at Frost & Sullivan, told us.

But for the US​, the situation seems trickier as the potential for a booming biosimilar market continues to skyrocket.

“The main regulatory issue is that when you produce a biosimilar, it has to be very similar to the biologic and reproduce the same results so when it comes to the US, they are hesitant because the biologics makers have had an upper hand so far,” Sashidhar said.

Biosimilars not only have to get through these “quality issues in the US” but the patent expiration dates on a lot of the biologics make it even more difficult, he added. “It’ll take a few years.”

Sashidhar’s guarded optimism seems to be the norm amoung industry leaders, with Hospira telling us recently it expects biosimilars could save as much as $250bn​. But state legislation​ may be another barrier to a more widespread integration of biosimilars.

Biosimilar developers are also still seeking more guidance​ on the US FDA’s plans for approving the follow-on biologics.


However, the obstacles for approving new biosimilars in India seem to be progressing without a hitch.

“In this particular report we mentioned India and analyzed their market and realized their definition of a biosimilar is more like a generic,” Sashidhar said. “We expect the definitions to become more stringent…now that it’s a hot market.”

How compulsory licenses will impact the Indian market, however, are unknown, he said.

Dr. Reddy’s is one of the more obvious examples​ in India of a company with a decent track record, looking to bring more of its biosimilar products to Western markets within five years, in addition to India.

Eastern Europe, Korea and LatAm

As the EU, US and India continue to trade barbs over what exactly should be a biosimilar, some companies may look to bring their biosimilars to market in eastern Europe and Russia first.

Sashidhar gave the example of Johnson & Johnson’s Remicade as one biologic in particular that saw its patent expiry extended to February 2015 in the West, but in “some of the eastern European countries, like Russia, [J&J] doesn’t have the exclusivity rights in these countries, so [competitors] might first launch the biosimilar there.”

J&J and the European Generics Association​ also recently traded heated words over how a biosimilar should be named.

South Korea​ and Latin America are also seeing similar signs of progress, he added, noting that Brazil is one particular country that uses compulsory licenses for the benefit of millions.

“In countries like Korea, some of the non-pharma companies, like Samsung and LG, are entering the biosimilar space and are collaborating with local pharma companies,” Sashidhar said, noting the potential blockbuster nature of the space.


But for one of the world’s fastest growing markets -- China – “the situation is different,” Sashidhar said. “They have the products launched, but they have a long line of manufacturers…looking for cheaper drugs.”

Questions around quality will be paramount as China will soon be the “biggest exporter of biosimilars” especially as smaller biotech companies flourish there.

“The key is that countries differ, so buying up smaller companies will be necessary,” he concluded.

Related news

Show more

Related products

show more

Process optimization for mAb commercial manufacturing

Process optimization for mAb commercial manufacturing

Content provided by Catalent | 01-Jun-2023 | Product Presentation

Process characterization and validation is an important step in the product development journey and late-phase development, and it is required before transferring...

Related suppliers