M.S.Nagendra
Director General
Zydus Pharmaceuticals
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Market Strategies to Capitalize on Pharmaceutical Opportunities

By Miriam Bello | Wed, 10/21/2020 - 10:46

Q: What are Zydus’ most recent introductions to the Mexican market?

A: We conducted phase 3 of clinical trials in Mexico for Lipaglyn (saroglitazar Magnesium) to treat Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH). NASH is a progressive disease of the liver caused by metabolic disorders and a significant unmet medical needs. During clinical trials, we recognized the potential this product had as the only drug developed to treat such an ailment. We completed phase 3 of clinical trials and Mexico took part in the process. Zydus has already got DCGI approval for this one-of-a-kind drug in India and we are also looking to gain its approval in the US and Mexico. Once we get the NASH approval in Mexico, we will introduce it to the country as soon as we can.

Q: How is Zydus capitalizing on the biosimilar market opportunity in Mexico?

A: We are in the process of registering biosimilar products in Mexico. However, in the last couple of years, COFERIS has a long gestation period for its approvals and this has delayed our process of introducing such a portfolio to the country. When this regulatory landscape improves, we will certainly move forward with the project which will help improve access to Mexican patients in need.

Q: What are the challenges that the biosimilar market faces in Mexico?

A: Costs are very high to meet the current regulatory requirements and this is not an investment every company is willing to make. Globally, the reality is very similar. The international biosimilars market represents around US$25 billion and Zydus is targeting a portfolio worth US$65 billion with a substantial variety of 21 products.

To dabble in this market, companies need to have a concrete business strategy but more importantly, they need the financial support that can allow such an investment. As a result, there are still only a few competitors for such an attractive market. This affects access to medicine and healthcare expenditure, which is only growing due to the elevated prices of products and the lack of competition. If the government allows more players, the system could benefit and medicine access would become a reality. The Mexican government should take a look at the biosimilar market and players and allow more competition by adapting the regulatory framework, favorable to investors and end users.

Q: Does API production present similar market challenges as biosimilars in Mexico?

A: Mexico has a strong pharmaceutical legacy and history. Both international and local players meet strict regulatory requirements but there are still opportunities and gaps in terms of technology and innovation. API production is one of those gaps as there are just few local companies dedicated to their API production. India and China, for example, have taken pro industry policies to encourage API producers and if the Mexican government encourages investors for API manufacturing, it would further strengthen the local pharma industry.

In the meantime, Mexican producers can leverage India’s API know-how, technology and capabilities to address market needs.

Q: How has Zydus advanced on its plans to introduce vaccines to Mexico?

A: Vaccine introduction is one of our most import global goals. The global vaccine market is around US$60 billion and Zydus has positioned itself as an emerging global player in this market. We have a unique distinction already: we are the first Indian company to launch a tetravalent vaccine in India. We are the second company to launch a TD vaccine. Now, we are among the few companies in the world working on a COVID-19 vaccine development. Zydus’ development is called “ZyCoV-D” and it has already entered Phase 2 clinical trials. If Phase 3 is completed by 2021, we have the ability to launch it fairly quickly. Mexico is an important participant in Zydus’ research and we have established a very positive relationship with the country. We are running two trials for COVID-19 in the country, both representing a substantial investment in terms of R&D.

Q: You have recently allied with the government of Hidalgo to be part of a pharmaceutical cluster. Why was this project of interest to Zydus?

A: We try to be meaningful players in the countries where we are present, which is why we are interested in collaborating through positive actions that boost the industry. Zydus tries to leverage its strengths in areas of market needs. For instance, Mexico has gaps to develop complex technological solutions for things such as injectable devices, so Zydus plan to fill in those gaps and improves access to those solutions. In CNS, Zydus has successfully introduced many products that could be very beneficial to the Mexican population. For complex generics, Mexico’s regulatory framework involves long approval times regardless of the good history of the product in the recognized reference countries. Regulatory barriers can sometimes hold us back from introducing products to Mexico and this is discouraging, considering the investment and technology solutions we can bring to the country.

Q: What is your opinion regarding the UNOPS medicine purchase for the public healthcare sector?

A: This situation is evolving and I am in the process of understanding the whole scheme.  Currently I have more questions than answers.

 

 

Zydus Pharmaceuticals is an Indian generics and innovation driven laboratory and part of Cadila Health care Group. In Mexico, it offers solutions mostly in the CNS area and hopes to soon commercialize NCE, biosimilars and vaccines, becoming a research-based company.

Miriam Bello Miriam Bello Journalist and Industry Analyst