SINGAPORE – South Korea and India are likely to remain the leading players in the biosimilars space in Asia and widen the lead they have on China, which remains a distant third.

The regulatory approach of each market, development costs and drug pricing are all factors that will determine the success of each market, said executives on Wednesday during the 2015 BioPharma Asia convention at Suntec Singapore.

Taking those factors into account, China has "zero" chance of becoming a significant global biosimilar player any time soon, said Steven Lee, CEO and global head of technical operations at Dr. Reddy's Singapore Pte Ltd.

South Korea is already in the space with several products such as Celltrion Inc.'s biosimilar of Remicade (imfliximab, Johnson & Johnson), which is already undergoing the approval process in the U.S. and could become the first biosimilar monoclonal antibody filed through the FDA's biosimilar regulatory approval pathway.

Korean companies like Celltrion and Samsung Bioepis, which expects to launch biosimilar products in 2016, have put a significant amount of resources into developing biosimilars and other biological products looking to shore up the country's biopharmaceutical capacity.

They're also eyeing the global market, especially Europe and the U.S., rather than just their domestic markets or other markets in Asia.

"I would say the most cutthroat biosimilar competitors in the future would come from Korea," said Lee. "They have resources. They have technology. It's only a matter of time."

India, for its part, is looking to replicate its success in manufacturing generic chemical formulations by developing new low-cost products. But developing biosimilars is likely to become more challenging.

"India has much experience in biosimilars that nobody knows about," said Lee. "Biosimilars in emerging markets is a whole different game. We don't have to play the formal game because local governments will help local companies," he added. "They need affordable medicines much more than the Western market because people don't have money to pay for them.

"The trick is low clinical cost in India, so they don't have a cost of goods plus clinical cost problem, so they can afford to drop the price," Lee continued. "Ten or 20 years later, you can't compete in the market based on cost of goods; that's the trend eventually.

"Given time, some of the big pharmas will order from India," said Lee. "That's what generics are doing."

That low-cost advantage should work in India's favor over time.

"It's not now. Indian drugs have all kinds of issues," Lee said. "But many years down the road, the market will go to wherever the cost is the lowest.

"It's not going to make big money. There's going to be price cuts year after year. India is this way. China will be this way," he explained. "It's like what we see from the generic market; it's already happening.

"China's left out in the generic market. India is decades ahead, probably 20 years," said Lee. "The same will happen with biosimilars. . . . The price differential is too small for doctors to switch to a different drug. Patients wont take it."

Pricing is a big drag on the Chinese market. One that multinational biosimilar makers are seriously considering.

For example, over the past several weeks multinational Sandoz Inc. has been in discussions with the CFDA, but the company is still not positive about the market. Fear of regulated pricing and constant cuts by governments looking to lower their costs could keep some companies away.

"Everyone is talking about the $20 billion big market, but by the time your products come out, it will be a $5 billion market," said Sreedhar Sagi, regional head of medical affairs for Asia Pacific at Sandoz Biopharmaceuticals, a Novartis AG company focused on developing biosimilars.

The CFDA introduced guidelines for biosimilar development only last month and the approval pathway for biosimilars is still the same as for new drugs, which translates into a lengthy process before approval. (See BioWorld Today, March 5, 2015.)

Sandoz has been talking with the CFDA about entering the market, but any such moves are still very much in the air.

"The CFDA's clinical trial data expectations are very high. They request a full-blown data package," Sagi said. "They're more likely to expect global companies to do licensing deals with local companies. . . . You'll have to have a local partner to do business in China."