HYDERABAD, India – Indian companies, backed by the government, are making a strong push to become world-class biosimilar manufacturers. And they might have a shot at that status if they can overcome chronic problems with quality control, limited funding and the fact that making big molecule biologics can be much more difficult than developing and manufacturing the small-molecule generics that long powered the country's pharmaceutical industry.

India wants to repeat with biosimilars the success it had with generics. The government hopes companies will tap into two of the country's key strengths in process chemistry and information technology. Meanwhile, companies are, for their part, increasingly focusing on developing and manufacturing biosimilars, researching and launching new products with an eye to tapping the domestic market and other emerging economies as a step toward more developed markets.

"There has been a great surge in biosimilars in the country, initially for our own market," said Ajay Bharadwaj, CEO of Bangalore-based contract research organization Anthem Biosciences, during the BioAsia 2016 conference earlier this month. Anthem now has an Anthem Biopharma division and a division focused on biosimilars.

The number of companies in India with biosimilar portfolios is growing and includes Mumbai-based Cipla Ltd., Bangalore-based Biocon Ltd., Hyderabad-based Dr. Reddy's Laboratories Ltd. and Ahmedabad-based Zydus Cadila Group.

Hyderabad-based Hetero Drugs Ltd. in 2015 launched its own biosimilar rituximab under the brand name of Maball. The drug is a version of Roche AG's Mabthera for non-Hodgkin's lymphoma and leukemia. And Torrent Pharmaceuticals Ltd. announced the launch of a biosimilar version of Humira (adalimumab, Abbvie Inc.) by 2016, under the brand name Adfrar, to treat autoimmune disorders.

But even with the technology to produce complex biologics, Indian companies have to overcome other handicaps such as a shortage of funding.

To that end, both government and the private sector are beginning to make investments into early research and development, said Gopal Dasika, vice president and head of biologics at Hospira Healthcare India Pte. Ltd. Multinational firm Pfizer Inc. acquired Hospira last year and Dasika now also heads the biosimilar R&D unit at Pfizer in Chennai.

Dasika, however, is also concerned that slow approval processes and weak quality control – as well as weak quality control regulations – could prove to be the Achilles heel for India's nascent biosimilar industry.

"We have come a long way, but we need to stay focused to do better. And we need to improve quality," he said.

ADVANTAGES AND CHALLENGES

Developing biosimilars takes a longer time than the small-molecule generics that India excels at producing, as they are larger and more complex and require extensive demonstrations of comparability with the original molecule at every stage of manufacturing. Still, for biosimilar developers and manufacturers, India offers two key advantages.

One is a lower cost of manufacturing. It can cost between $10 million to 20 million to manufacture a biosimilar in India, which is 25 percent to 40 percent cheaper than in developed countries. Another advantage is that there are plenty of skilled human resources, particularly in areas such as process chemistry and computer-based analytics.

India can have a "first-mover advantage" if it invests early in research and development of new biosimilars or an "early mover advantage" if it invests in research on biosimilars with few makers, said Satakarni Makkapati, president for biologics at Aurobindo Pharmaceutical Ltd., a Hyderabad-based biopharma company. At the same time, India's plentiful information technology skills can come in handy for the extensive analytics involved in biosimilar development, a process that requires "totality of evidence" on comparability with the originator molecule.

But India still needs to learn how to position its biosimilars in global markets, which tend to fall into three broad categories, Makkapati said. In the first category are the highly regulated markets of advanced countries such as the U.S., European countries and Japan. A second category includes emerging market economies such as the BRICS – Brazil, Russia, India, China and South Africa – where regulation is less stringent. A third broad category includes Mexico, Indonesia, South Korea and Turkey.

As was the case with generics a couple of decades ago, India may have bigger opportunities to tap into the second and third categories, where there is high demand for treatments for acute conditions such as cancer, said Satakarni. By contrast, the uptake of biosimilars in more advanced economies is lower and physicians are more likely to use biosimilars only to treat chronic conditions such as rheumatoid arthritis.

To make a dent in more regulated markets, Indian companies should undertake more studies on interchangeability and suitability of biosimilars with drugs currently used for treatment of acute diseases

But just proving that their biosimilars are as effective as existing drugs is only one challenge that companies have to overcome. As far as Bharadwaj is concerned, a second and more significant challenge for India in the biosimilars sector is to not just make biosimilars but to make affordable biosimilars that the Indian population can access. For that to happen regulators will have to put in place approval processes that are easier and quicker than what is in place now.

A third challenge is building capacity to understand the specifics of biosimilar research and development, said Prabhudda Kundu, co-founder and executive director at Premas Biotech Pvt. Ltd., of Gurgaon, near New Delhi.

A fourth challenge is overcoming the logistics to use biosimilars, especially developing cold chains that span from the point of manufacturing to delivery to users. Recently, Ahmedabad-based Intas Pharmaceuticals Ltd., which in June 2015 launched Razumab, a biosimilar to Roche's ophthalmology drug Lucentis (ranibizumab), had to deal with stray cases of eye inflammation which it attributed to improper cold storage.

"The coming years will tell whether India will be able to take its biosimilars sector to the next level," Makkapati said.