South America and specifically Brazil and Argentina are very important markets for India in the future. Indian pharmaceutical and biotechnology companies can make a big difference in Brazil in particular and South American markets in general. This is despite the mammoth presence of the multinational companies. India’s cost arbitrage and with the right partnering or acquisition, can help companies make a promising headway in the region. The cost of therapy would be key decision parameter, if all the safety and clinical data submitted is positive, says Ajay Bharadwaj, CEO, Anthem Biosciences in an email interaction with Nandita Vijay. Excerpts:
How would you describe the importance of BRICS (Brazil, Russia, India China and South Africa) specially the Brazil for bio pharma companies from India?
Clearly these countries are very important as they are the emerging economies of the world. Of course the registration rules and requirements are very different for each. Brazil in particular is among the most important, because it has transparent rules and a higher health spend per person than most of the other BRICS countries. Biological therapeutic products are among the most expensive treatment options for patients but are highly recommended because they are often potent, specific and have relatively little side effects. Brazil, like all other emerging countries, is keen to lower its cost of therapy and bring these treatments within the reach of its larger population, without compromising safety or quality. Indian biosimilars which have been extensively tested clinically and have gone through due process of registration are likely to win big in BRCS countries.
How do you think the Indian bio pharma companies including Anthem can leverage the opportunities in Brazil and South America?
Luckily, many biopharma companies have had exposure to Latin America and many of them have already established a beach head with their products. This does make life easier for others to follow. Anthem has also got their own representation, and registrations are underway. What is underexplored is the biopharma services potential in these markets. That could present an opportunity. Going forward as business expands we would also be keen to look at a manufacturing site in Brazil or Argentina as that would allow us to be close to the markets. It is imperative that companies like ours have a global manufacturing footprint if we are to truly unlock our potential.
Could you take us through some of the initiatives by Anthem to tap Brazil and the other markets of South America? How receptive is Brazil towards Indian bio pharma companies and what are the drugs they are looking for?
Selection of the right products, where Anthem has strengths and there is a technologically superior product opportunity, is the key. After identification of the right product, the right type of documentation has to be filed. Having a local representative to assist in filing and collating the right data is important. Brazil is an open country and they are looking for the same portfolio of drugs like Insulin, GCSF, Vaccines etc that are increasingly being made by Indian companies. As the world gains wider experience with biosimilars and the patient population on these products grows even more significant, the last vestiges of resistance would crumble and policies and guidelines would be made friendlier for biosimilars. Let’s not forget that a couple of decades ago there was tremendous resistance to Indian generics (small molecules) and today we are the pharmaceutical factory of the world. So in the not very distant future Brazil and other South American companies would adapt even more complex biosimilars like monoclonal antibodies etc. Anthem is putting in place the regulatory compliance which allows us to benefit from these changes.
Would there be opportunities for the unique Anthem DRAP model here in this region?
Hard to say, as there are not enough discovery based companies there. However, there are other services where this market is underserved. We are exploring those. Having said that it is again a matter of time when the region will boast of its own discovery companies. Brazil has some world beating companies in other high tech areas like Emberaer in aviation, Petrobras in oil exploration. I am confident that as the scientific talent pool gets built drug discovery would also be pursued. Our DRAP model would be useful for such companies.
What is the competition for you in this region?
Since ours is a diversified portfolio from services to products, we do not have a single identified competitor. Since we supply enzymes, probiotics, nutritional products, dietary supplement, we have a number of competitors from all over the world in each of those categories. And the competition would only get fiercer but I believe we have the scientific differentiators to create an impact above and beyond our competitors.
How tough is the regulatory environment here and the kind of technical documentation required for Indian bio-pharma to make a presence?
Anvisa registration is more and more in line with current guidelines from US FDA, EMEA etc with some small differences. So one has to have the same level of regulatory compliance and data as advanced countries, including clinical data. So if one has to be in these markets one has to be prepared completely.
There is also a huge presence of multinational companies here, now how are Indian bio pharma positioned to garner a share of the opportunity?
Even though multinational companies are present in full force, with our cost arbitrage and with the right partnering or acquisition, Indian companies can make a dent in these markets. As I have said earlier the cost of therapy including for biosimilars is the key decision parameter, if all the safety and clinical data is positive. I believe we will be able to provide the right data for the users to decide, whether they want to pay horrendously high prices or use cheaper, yet equally safe alternatives.
Going forward what is Anthem’s action plan in India and globally?
We are investing in a bigger facility which would also be fully approved by the likes of US FDA, EMEA etc. Our labs are getting GLP accreditation this year. We have invested a lot of money in research and will continue to do so in the coming years. Our new manufacturing facility should be ready by 2015. We are already present in all the main markets with our research services and in the last couple of years have started exporting our actives in South Asia, South East Asia, Middle East and Latin America. We expand to increase this to developed economies by next year.