Interview with Adrián Ruiz, Director General of Hetlabs Mexico
Adrián Ruiz, Director General of Hetlabs Mexico
Q: Hetlabs was recognized as the most important Indian company in the Mexican pharmaceutical industry by a study conducted by IMS Health – how has the company grown in the last year in terms of market authorizations and patents?
A: In the fourth quarter of 2014, we received 65 market authorizations for finished dosages for different customers. Also, as an active pharmaceutical ingredients (API) supplier, we have a lot of interaction with the development areas of our customers and we have 35 new market authorizations for these products now. Hetlabs itself has 91 market authorizations for different molecules and 81 licenses. In addition, we have submitted new fixed combinations to the IMPI gazette and four of our patents for innovative molecules have been published, so we are submitting two more. We are planning to launch these products next year and we expect revenues not less than US$10 million per molecule. We have one fixed combination product for erectile dysfunction that we expect to position in the top five for products of this kind and we also want to be ranked top five biggest companies for cardiovascular and central nervous system. In the specialty care business segment, we have submitted three more patents for antiretroviral (ARV) drugs, where we are the world leaders with a market share of 30%. We are launching more products in this area in the first quarter of next year in a joint venture with Vanquish Pharmaceuticals. With this, we are planning to have at least 15% market share of ARV in Mexico in the first year and 30% in the second year as in the rest in the world.
Q: How would you describe the current state of the Mexican pharmaceutical industry and what is your strategy to remain competitive in the market?
A: Mexico has become one of the most interesting markets in the world. In the past, the black market used to have a strong position as 30% of the country, including remote regions in Michoacan and other states as well as big cities such as Guadalajara and Merida, were not covered by any formal distributor. This has changed in the last years; pharmaceutical companies and distributors are reaching those areas now and along with a stronger COFEPRIS, they have worked on weakening the black market. Moreover, the population is undergoing a cultural transformation in which patients are more informed and demand better services and physicians evaluate the benefits and risks of medications more carefully. People not only want to turn 80 years old, but they want to do so having a good quality of life. Multinational companies are implementing programs to help patients to take charge of their chronic illnesses. Furthermore, regulations have become stricter and today, conducting bioequivalence studies for generics is not enough, active pharmacovigilance is an essential requirement that generic producers should comply with in order to demonstrate safety of their products. Mexico is starting to reap the fruits of all these efforts and I would say that at this point we have more opportunities than challenges. Balancing quality and price is perhaps the most important challenge for companies today. As the most successful Indian company, we are committed to complying with all regulatory requirements and thus we will only compete against those companies with the same level of quality and compliance.
Q: Last year you shared with us your plans to build a manufacturing site in Mexico – what has happened since then?
A: We acquired one of the best facilities I have ever seen and rebuilt it in order to be a high specialty manufacturing site aimed at producing biosimilars and cancer drugs. We found the right partner in Mexico and we will hold 90% of the company. In this ever changing market, we need greater capabilities helping us to overcome our weaknesses. We have already established communications with the Subcommittee of Biotechnology Products at COFEPRIS, and we have presented the layouts for biosimilars manufacturing to it. In addition, we have had a pre-meeting for the authorization of our first biosimilar and we are working closely with CONACYT and the State of Mexico’s Council for Science at Technology (COMECYT). In addition, we are committed to developing talent in this facility. In the beginning we will have Indian people working on the technology transfer process and then Mexicans will be fully involved. This site will supply biosimilars to the whole Latin American market in an initial stage. Secondly, with the site complying with EMA requirements, we will export products to the US and Europe. As Mexico gains greater recognition among those countries, exports will be easier from Mexico than from India. We are conducting preclinical studies in mice and monkeys, and clinical trials phase I, II, and III for biosimilars in Mexico. Biosimilars’ characterization includes non-inferiority studies, knowing the behavior of the drug in patients, and assessing the risk management of the products. In the near future we will begin the phase I of a product in collaboration with UNAM.
Q: How easy will it be for Hetlabs to tap into the biotechnology market in Mexico and how eager is the government to acquire low cost versions of biopharmaceuticals today?
A: The Mexican regulation is at the level of the EMA; however Europe has several years of experience in this area while Mexico is just going through the learning curve. There are strong committees in the chambers pushing forward biotechnology. COFEPRIS wants more biopharmaceuticals to be available in the market allowing more people to have access to these treatment. To achieve this, all stakeholders need to understand the business and regulatory environment of these products. Phase III and IV clinical trials have been conducted in Mexico for many years and today companies are interested in conducting phases I and II. Biopharmaceuticals are much more complex than chemical drugs, not only in terms of manufacturing, but also transportation, for instance if they are agitated they might lose their properties. Therefore, it takes three months to release the product for quality assurance in Mexico when it arrives. In this case, we are not providing a bioequivalence study, but non-inferiority studies, which is the reason why they are called biosimilars – they are not identical to the innovator.
The first line of products we are introducing to Mexico under this scheme are the monoclonal antibodies, and we are taking the time to comply with all COFEPRIS requirements, which is why we have delayed the launch of these products. The question is whether these products will participate in the same tenders as innovators, and how IMSS and ISSSTE are going to manage them. Now that the rules are clear and transparent lots of companies are competing to be the first. Despite the government needing low cost biosimilars urgently, it does not want to infringe patent issues or affect the revenues of multinational companies that have invested a lot in the development of these products over the years. The market is completely aware of the patents protection today and nobody wants to have a problem with intellectual property in Mexico.
This is an excerpt of Mexico Health Review 2016 to be launched on September 7, 2016 at Mexico Health Summit. For more information visit: www.mexicohealthreview.com and http://mexicohealthsummit.com/