Biosimilar Capabilities and Market Potential in Asia

Pharma IQ

Epogen, Neupogen and Enbrel are three biologics which have already seen their patents expire, and Herceptin and Avastin are to be added to this list in the not too distant future.

By 2015 the global market for biosimilars is expected to reach $4.8 billion (£3 billion). Although Europe is expected to be the largest affiliate market for biosimilars, markets outside of Europe, the United States and Japan will collectively account for a greater share. 

There are a host of factors driving this growth, according to the biosimilars market report from Global Industry Analysts. Aside from the patent expiries, ageing populations and the introduction of supporting legislation will both spur growth.

The pharmaceutical manufacturing expertise within Asia has helped a number of companies in the region secure lucrative biosimilars contracts in recent weeks.

Mumbai-headquartered company Lupin said in five years that 5 to 7 percent of its business will come from biosimilars and the aim is to get its first biosimilar drug on the Indian market by the end of the year

It recently signed a deal with NeuClone Pty Ltd for the acquisition of cell line technology for the development of cancer therapies, as part of a wider strategy to capitalise on gaps emerging within the biologics market place.

"The multi-billion dollar opportunity, with blockbuster biologics going off patent in the next five to eight years, is something that Lupin is pursuing aggressively," Cyrus Karkaria, Lupin president and head of the company's biological research programme, said. 

South Korean company Hanwha Chemical Corporation also recently entered into an exclusive global agreement with Merck for the development and commercialisation of a biosimilar for Enbrel.

HD203 is currently undergoing a Phase III clinical trial in Korea although testing has yet to begin in the United States. Merck will commercialise the candidate except for in Korea and Turkey, where Hanwha will keep the marketing rights. 

Michael Kamarck, president of Merck BioVentures, said: "Hanwha has established outstanding biopharmaceutical development capabilities. Enbrel is widely considered to be one of the most important biosimilar molecules."

It is these kinds of deals which will be needed to help the market take off, thanks to the expense of the development of biosimilars. 

"In today's tough and difficult economic environment there are not too many players who can and are willing to jump into and embrace this challenge. 

As of now some big players such as Sandoz, Teva, Pfizer, Hospira and Mylan do have sufficient funds and are not hesitating to invest in this area," Jack Aurora, chief scientific officer of generic drugs for Hisun Pharma, said in an interview with Pharma IQ. 

Aurora went on to predict the pool of companies producing biosimilars is likely to remain small over the next 10 years largely due to cost pressures. 

Similarly, some expect the market for biosimilars in Asia not to be significantly varied. Rather once developed they will be shipped to Europe and the United States, reiterating the need for strong guidance to be put in place to meet with tough regulatory standards in the region.

Tamotsu Fujino, director of international affairs for the Japan Generic Medicines Association, told Pharma IQ: "Since biosimilars will be also very expensive, the penetration in most of the Asian countries will be not so much except for life-saving drugs for very serious diseases such as various types of cancer, AIDS."

In terms of market growth, it is Japan which is expected to experience the biggest rise of a compound annual rate of 92.6 percent until 2016, however India is also well placed for growth. 

The challenge for Asian companies is securing more agreements like the one recently signed between Merck and Hanwha, which will allow them to develop their biosimilar capabilities backed by investment from multinational pharmaceutical firms.