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EF: Since the last time we saw you, you’ve upgraded your offices substantially—what good news do you have to report?
GK: We started in a very small space, half of what we have today and outside the city, but we’ve since grown three times as big! We re-built the organization from scratch as a decision from top management, we restructured, we have been through a lot of changes, and we brought in the right people. Hetero always had potential; we just released it. There is no great secret. We went back to the basics.
EF: Next March you will be celebrating 5 years in Hetero; to what would you raise your glass of champagne?
GK: I would celebrate building the company. Our goal is to reach the top 10 in Mexico, with strong manufacturing and a local presence, creating a robust talent pool that will benefit all of Mexico. This is what I aspire to; without talent, we can’t aspire to knowledge, and I would like to think that it’s just a matter of time and sustained effort.
EF: You once said that “worldwide many companies are ahead of us in terms of technology, however, none of them is able to make a real impact in the biotech segment in Mexico; they fail in various stages of bringing new molecules to the market because Mexico is highly regulated when it comes to biosimilars.” Is this still the case, and what regulatory advice would you give to the new administration?
GK: Biosimilars are still a far-fetched idea. For generic biosimilar companies as well as biogenerics, it’s a difficult subject for Mexico. They are coming but not very soon at all mainly because Mexico is difficult. A lot of rules and regulations need to be revised and updated but we are far from that process. From one administration to another, people and companies get disrupted and nobody wants to move backwards or forward. It’s a stalemate, and nobody knows what to do. It will take more time for things to settle and then very probably things will start working again! But, ambiguities are the norm the world over. Hetero has five products waiting for approvals for over two years now, and we would love to put them on the market. As a small pharma company, it will take time; you can make your moves but still, there is a cost and we have to ask ourselves if it is worth it.
EF: If you have tripled in size over the last three years, maybe someone is doing you an unintentional favour?
GK: A product from the development phase to the launch phase, even in generics, can take two years depending on how fast or how competent the R&D is. If I am lucky enough to be in the right place at the right time—where preparation meets opportunity—then 2019 will be a challenge. In order to mitigate it, we are entering B2C and concentrating on retrovirals, because Hetero has a 30 - 33% market share globally, but to be big players, we need a finished product. Of every three HIV/AIDS patients, one patient is on Hetero treatment.
Mexico is a selective market. It’s not the US or Europe, but it is selective, and innovations here cost money. You must invest in infrastructure and ensure bioequality, which can cost a difference from $100,000 to $300,000 for only this one part of the equation. But this is something the people who are in decision making positions do not think about, they have no idea. They just produce a list and say, “This is it.” All this is causing uncertainty in the market because they want to consolidate and save the cost, and this consolidation would affect us a lot. It is saving cost, but at what cost?