Mexican Pharmaceuticals Demand Government Support

Q: What is the reach of Laboratorios Liomont’s core business?
A: We are active in various areas of the market, with our core business being branded generics. In this area, we are market leaders for a number of products. We also offer a diverse line of OTCs. We provide internationally-recognized brands and participate in several markets in Central and South America. We are also active in the European market, where we have been approved by EMA and have a presence in Spain, Portugal and Italy. Similarly, we have been audited and verified by the FDA in the US, where we sell OTC products.
Apart from generics, we have built state-of-the-art facilities for the production of biosimilars and are also working on the development of vaccines. In Mexico, we have the rights to manufacture and distribute a recombinant vaccine for influenza that is unique in the world.
Q: Laboratorios Liomont has inaugurated a new plant for sterile and recombinant products in Ocoyoacac, Mexico State. What does this mean for the company?
A: Laboratorios Liomont has taken significant steps in biotechnology. We just finished constructing this state-of-the-art plant with the latest technology for sterile products. While still subject to approvals, we have already started doing the technology transfer for fill and finish of recombinant products. We are strong believers in collaboration with academic bodies in Mexico and other countries. One example of this is our work with UNAM’s biotechnology institute. In Cuajimalpa, we also built a biotechnology plant that will produce monoclonal antibodies, which will then be turned into finished sterile products at the Ocoyoacac site. The latter has been designed and built to manufacture large volumes of biosimilars and recombinant vaccines using the latest technologies based on isolators. Biotechnological medications produced at this plant will offer vital alternatives for the Mexican population. Having these alternatives available will also make it possible for the government to make significant savings in its buying schemes.
Q: Do you feel the government needs to take a more active stand in supporting Mexican pharmaceutical companies?
A: In terms of volume, the government has traditionally been a major buyer of our products. Since the last elections, things have gotten more complicated for participating companies. During the tender approvals in October 2018, we had a lot of prime material and finished products lined up, but the government recently stopped buying these products. What alarmed us in the last tenders was that reference prices had lowered to such a level that in most cases they were unattainable due to production costs. I think there needs to be more understanding from the new administration regarding increased manufacturing costs due to stronger regulations.
The government keeps insisting on more investment for quality control but at the same time, it expects prices to go down. This could make the entry of foreign producers more unfair if they do not adhere to the same regulatory standards for manufacturing. We are strongly committed to Mexico’s well-being and industrial development. The public sector should have a primary role in strengthening Mexican research and Mexican companies to ensure future accessibility to high-quality treatments.
Q: What is the status of new-product approvals?
A: At the moment, COFEPRIS is a black box. We have products ready and have applied for inclusion into the national registry, but we still do not have a response.  Officially, It can take between one to six months before you get a reply from the commission, even if the product meets all the necessary requirements. We have been in some processes for over a year but do not know their status yet. Especially when companies are expecting to enter markets where patents have expired, delays in approvals only help multinationals maintain a monopoly over certain treatments, which increases barriers and costs for the general population. Also, we lack a regulatory process that promotes innovation. CONACYT is not supporting R&D in the industry, so our collaboration with the council no longer exists. Sadly, this is pushing prestigious researchers to move to other countries to continue their work there.