API and Biosimilar Market Potential Knocking at Mexico’s Door

Q: How has the recent centralized purchasing scheme impacted the generics industry in Mexico?

A: Given the government’s decision to purchase medicine from international sources such as the UN, AMEGI is seeking dialogue and a closer communication with the federal administration to help the government see that we have so far covered that market successfully. Generics represent a significant part of the medicine supply, covering 90 percent of national demand. Moreover, this industry is a job provider and an investment attractor. Neglecting its importance can negatively impact a large number of formal jobs in the country, considering that the pharmaceutical industry generates around 600,000 direct and indirect jobs.

AMEGI is seeking clear and transparent tenders where all industry players can participate fairly to continue generating jobs, providing medicine for the patient and helping the government with its supply requirements. We can be an ally to the government just as the International Generic and Biosimilars Medicines Association (IGBA) is to WHO at the global level.

We have tried to approach the government through written communications during the pandemic and before that we held meetings seeking to contribute to fair and transparent tenders. The COVID-19 pandemic has brought significant changes regarding communication as the government seems more open and less defensive. We hope to form an alliance with the public sector to benefit healthcare for the long run, not just during the COVID-19 crisis.

Q: How might the integration of COFEPRIS into the Ministry of Health impact the generics industry?

A: We still do not know how this will impact our work; however, we have tried to approach the commission and we have not been successful. There has been little advance regarding our registries. I do see this as a positive because we are able to adapt to these changes and to have an active participation as representatives of the industry. We are open to dialogue with the authorities and to working alongside them to better represent our members. 

Q: What did the change in the IP law as a result of USMCA mean for the generics industry in Mexico?

A: AMEGI and IGBA were able to erase the 10 years of patent protection on biotechnological medicine. However, there are companies seeking to increase this to a 20-year period. We were also able to lift the mandatory requirement to announce the availability of new known products.

Q: How does AMEGI view the Mexican biosimilar market?

A: In the short term and considering our northern neighbors, AMEGI is interested in introducing biosimilar production to the country and starting its development because we see the benefits these products bring to patients. They target key segments of the population in Mexico as many of them specialize in Mexico’s epidemiological issues.

Q: How has AMEGI contributed to the fight against the COVID-19 outbreak in Mexico?

A: As an essential industry, we had to maintain our production lines during the outbreak. All AMEGI members have complied with protection and sanitary measures to protect collaborators. We are a highly regulated industry, which makes it easy to implement these measures and take control of the situation, avoiding outbreaks at plants.

AMEGI’s multinational members are joining efforts to support the battle against the COVID-19 pandemic and to try to secure the national distribution of a vaccine when it is ready. Moreover, with the government, we have acted as facilitators to reach the most vulnerable groups of the population by securing national production of our medicines at an accessible price and with the right quality.

Q: What have been the industry’s main concerns during this period and how has AMEGI helped its allies to brave the crisis?

A: Market contractions are a general concern for our industry. There have been concerns regarding supply as there has been a shift in demand that we were not expecting, which impacted costs and expenditure on basic production but also on protective equipment for the people on the production floor. There is also global pressure as there is no certain knowledge of what the future of the pandemic will be. We are managing our production based on demand. However, we do not know how much things will change in the aftermath of the pandemic. Also, we have refrained from visiting our clients and showcasing our products with doctors.

Aside from this, the new public purchasing scheme is AMEGI’s main concern. We see that uncertainty is keeping people away from their treatments as the government changes its supply rules.

Q: What areas of opportunity does AMEGI see in the API market for Mexico?

A: Eighty percent of Mexico’s API supply is foreign. In the midterm, AMEGI hopes to see local API production, given our strong dependency on local production. During the COVID-19 crisis, we saw how governments can close their borders or keep their production homebound. Luckily, the national industry has enough APIs and finished product stock to avoid production shortages.

Q: What are the main challenges that AMEGI foresees for the generics sector?

A: Even with USMCA, there are patent extensions, which mean a delay in the production of generics. We thought that with USMCA, this situation would stop. However, companies keep applying for extensions to their patents while we seek to start production on the day after these expire to offer those medicines to the public. We are also working to set fair prices because sometimes medicines are sold to the government at a certain price but in the open market the price changes abruptly. 

Q: What are AMEGI’s near-term goals?

A: AMEGI is looking forward to educating people on generic medicines so they can continue trusting this option. The Mexican population suffers from many chronic diseases and the use of generics has helped many patients. However, we want to strengthen their knowledge on the subject so that when we are ready to introduce therapies such as biosimilars, patients can see them in a positive light, as well. It is very important to sensitize the patient to the quality of generics so they do not stop a treatment just because they do not trust the efficacy of the product. Our end goal is to offer medicine at affordable prices with the same quality as patented products.

The Mexican Association of Generics (AMEGI) is a private organization created in 2002 to represent the interests of six generics manufacturers operating in Mexico: Allen, Apotex, Hormona Laboratorios, Randall Laboratorios and TEVA