Rafael Maciel
Medical Director/President of AMEGI
View from the Top

Exponential Growth Thanks to Fulfillment, Accessibility

By Miriam Bello | Fri, 09/24/2021 - 12:30

Q: How does Apotex ensure the safety and efficacy of its products?

A: Our biosimilar interchangeability studies validate generic medicines and prove their equivalence, safety and effectiveness in comparison to the innovative drug. The protocols for these studies follow international guidelines created by WHO and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). These studies are submitted to COFEPRIS for approval.

While products manufactured in Canada undergo these studies there, COFEPRIS asks us to perform them again in Mexico. This means that our products have a double certification.

Q: What developments in Apotex’s pipeline are expected to have a large impact on Mexico’s epidemiological profile?

A: Mexico found itself facing a dramatic scenario because patients dealing with diabetes, obesity, cardiovascular diseases or chronic respiratory diseases were at higher risk of COVID-19. Considering the severity of this problem, Apotex is developing a more responsive portfolio of solutions. We are developing solutions for cardiovascular disease, hypertension and peripheral vascular insufficiency. Other products in our pipeline include treatments for diabetes, which affects around 10 percent of Mexico’s population; child and adult obesity, in which Mexico is almost the global leader; and cancer, an area for which there were treatment shortages recently at public institutions. We are also entering the biotechnology field, where we hope to introduce high-quality drugs in the near term.

At the end of the day, generics are meant to reduce the impact of medicines on a patient’s pocketbook. They provide an affordable alternative to patients and health systems.

Q: How is Apotex approaching medical professionals with its products after the COVID-19 pandemic?

A: During the pandemic, we had to change our approach to doctors and adopt technology to meet with them. Prior to the pandemic, this was almost impossible to achieve because scientific meetings online were uncommon. This trend has changed and now it is possible to speak with doctors from Mexico and Latin America more easily. We have received positive feedback from doctors and scientists, which has propelled our brand in the region. Through technology, we have been able to establish faster communication to answer their doubts.

We have also implemented virtual visits with doctors to discuss our products and share clinical trial results. As Mexico reopens, we have been able to meet in person with some doctors. We are also implementing an innovative approach with patients: an on-line pharmacy called “Apotex Click.”

Apotex has learned from the pandemic that the experiences of patients and doctors have changed, so it was necessary to create a different approach to ensure they could continue receiving our care. Technology has been an essential ally to achieve access to healthcare despite the challenges.

Q: How did the pandemic impact the use of generics in Mexico?

A: In the public sector, generics uses decreased by 22 percent in units and by 8.5 percent in value as a result of new medicine contracting processes, which caused many implementation challenges and led to medicine shortages. The decrease was mostly seen at IMSS, which was missing 30 percent of the units it required. The shortages drove patients to seek medications in the private market. The majority of the missing drugs were for cancer or other high impact diseases.

During this period, the demand for ivermectin, azithromycin and paracetamol skyrocketed. Paracetamol has been among the most in-demand drugs during the pandemic. Demand for medicines to treat COVID-19 symptoms grew by 66.9 percent, while molecules for non-COVID-19 diseases grew by 2.9 percent.

The market for generics grew 8.6 percent year-over-year in 2020, which represents an extra 94.6 million units, despite Mexico’s 8.2 percent GDP contraction during that same period. In July 2021, generics sales grew by 9.3 percent year-over-year, so the market is still growing. Generics are seeing double-digit growth and OTC products are also growing between 26-28 percent.

Q: Generics make up most of the medicine purchases in Mexico. How has UNOPS’ acquisition process impacted the generics industry?

A: COFEPRIS is strengthening its communications with the pharmaceutical industry and with global regulatory agencies, which will benefit the pharmaceutical sector in Mexico. COFEPRIS was previously considered a reference agency by PAHO and current Commissioner Alejandro Svarch is working to regain this recognition because it reflects the commitment of the Mexican pharmaceutical industry.

Before the arrival of Svarch, the pharmaceutical industry suffered from a significant delay in approvals. Now, COVID-19 products are the agency’s priority but there is still a significant lag in approvals and other procedures. To resolve it, Svarch has said that the agency would likely integrate more staff. In the meantime, we are still unable to meet with COFEPRIS and we are still depending on them to obtain the final approvals.

AMEGI will always help the government accelerate its approval processes. The final goal of COFEPRIS and the industry is to get medicines to the public in a timely manner.

Q: How has the biosimilar market grown in Mexico and how interested are your members in participating in this segment?

A: The market for biosimilars has experienced moderate growth because few companies are producing them. The legal background for the patents of these products is complex so the industry is hesitant to dabble in this market. Some biosimilars have reached the market but they are few. In the EU, biosimilars had a positive impact on diseases like cancer and rheumatology and they could also benefit patients in Mexico.

Biosimilars are a great opportunity for the pharmaceutical market and joint actions by the government and the private sector could facilitate the conditions for local companies to produce biosimilars. A similar situation arose with biotechnological products because the USMCA introduced a patent consideration that did not exist in NAFTA, which will delay the introduction of biotechnologies in the market.

Q: What opportunities does AMEGI see in API manufacturing, especially after the disruptions caused by the COVID-19 outbreak?

A: The API market is dominated by India and China, which manufacture products consumed by every pharmaceutical manufacturer around the world. API shortages could cause global disruptions, which remain a concern as there are COVID-19 peaks still going on in every region of the world.

Years ago, the pharmaceutical industry had more API manufacturers. Apotex remains one of them but we need to strengthen this industry to avoid future shortages. AMEGI sees an investment opportunity in this segment but, to grow this niche, the government needs to promote Mexico as a producer of APIs and help the industry export them to our commercial partners. Strengthening this market would make Mexico a complete provider of the pharmaceutical market and make the country less dependent of foreign suppliers. WHO, WIPO and WTO are also working to diversify API manufacturing and propel their production in different countries.

Q: What role will generics play in the development of Mexico’s pharmaceutical industry and the country’s position as a manufacturing hub?

A: The pharmaceutical industry’s role in Mexico’s economic recovery is dependent on its ability to supply the medicines required by both the public and private sectors in a timely manner. The generics industry will continue to be an ally of patients during these challenging times and help them access medicines.



Apotex is a Canada-based manufacturer of generic and innovative drugs that sells medications in over 115 countries.

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.

Miriam Bello Miriam Bello Journalist and Industry Analyst