Generics, Biosimilar Leader to Expand Access, Reduce Costs

Q: How did Sandoz achieve its leading position in the generics sector and what strategies has the company implemented to maintain its leadership?

A: Sandoz is the second-most important generics brand in the world, which is a matter of pride for the company. As part of Novartis, we are generating innovation and providing accessibility for our patients. Our successful generics portfolio provides global institutions with savings, giving them the opportunity to invest in other products or supplies.

Sandoz’s strategy is straightforward: be the first in and the last out. Our goal is to be the first generic in the market and the last remaining through cost competitiveness and supply stability. This successful strategy has allowed us to introduce 25 new molecules to Mexico in the last five years (5 molecules each year).

Q: How has Sandoz contributed to maintaining economic stability throughout the pandemic?

A: The pandemic was rough for all companies. At Sandoz, we are honored to be working with over 3,00 employees, who all maintained their jobs, salaries and working conditions despite the economic situation. Our employees are out priority; therefore, for a year, none went into the field to promote products. Sandoz is trying to shift the company’s employee culture. We were recognized as a Top Employer due to our innovation on work modalities. We are trying to change the 8-to-5 model to something we call the “unboss” approach, in which employees can manage their time by owning their results.

Sandoz has a large supply of all its products, which allows us to support access to medicine. We have a single united supply line for the entire company that allows us to plan our production and distribution accordingly. While this could appear to be a disadvantage, for Sandoz it has meant quality and excellence, which is essential to the generics industry. 

Q: How can generics manufacturing contribute to pharma’s role in reactivating the Mexican economy?

A: We continue to invest in this industry and recognize it as a pillar. Sandoz previously invested US$0.5 million a year in new launches for Mexico, but starting last year, we decided to invest five times more. In 2021, we will be investing almost US$2.5 million and developing more than eight products annually.

Q: How is Sandoz expanding its biosimilar line and promoting its benefits in terms of cost and effectiveness in Mexico?

A: Sandoz’s main objective is to become the leading biosimilar brand in Mexico, mirroring our position in the global market. We now have eight available biosimilars, of which three are available in Mexico: somatropine (Omnitrope), filgrastim (Zarzio) and rituximab (Arasamila). In the next 18 months, Sandoz is planning to introduce four more, with two of those coming in the next 12 months.

Biosimilars are complex molecules and their cost might make their acquisition harder for some institutions. For that reason, offering biosimilars at accessible prices would be a milestone.

Introducing biosimilars into Mexico has not been an easy task. Sandoz introduced the first biosimilar to the US and Japan (somatropine) but this remains an innovative area for most countries. Physicians need to understand the exact benefits of these new molecules. To introduce biosimilars into the Mexican market, we are approaching physicians to explain the safety and quality of these therapeutic options, as well as the savings they can bring to healthcare institutions.

Before they enter the market, these molecules must be approved by COFEPRIS’ Committee of New Molecules. At this point, COFEPRIS, like every other regulatory agency in the world, has its hands full with COVID-19 approvals but we are confident we will get our approvals. COFEPRIS has also optimized its processes, which are now simplified, digitalized and accepted in English.

Q: How does Sandoz’s global expansion permeate the company’s offering in Mexico?

A: We are investing to expand our antibiotic production in the EU, which is our leading region for sales. In this expansion, we are investing in AI to provide much better market forecasting. Sandoz’s investment in antibiotics is also our largest bet.

In the last five years we have been experiencing a double-digit growth so following this path is a priority. Our second priority is to promote biosimilars, which can provide savings to patients.

Q: How is Sandoz integrating technology to deliver better therapies and boost R&D data access?

A: We normally invest 20 percent of our sales in new molecules and we will continue to do so to save lives. We recently introduced an HIV therapy (emtricitabine/tenofovir) that has provided great comfort to the patients who need it. In the next 12-18 months, we plan to introduce Pre-Exposure Prophylaxis (PrEP) to the public sector, although we have already launched it in the private market, where we now have about 500-1,000 patients paying out-of-pocket. PrEP is a medicine taken to prevent contracting HIV, so it is difficult to estimate its market reach. PrEP has been considered in the UNOPS tender but we have not been informed how much product is required. Despite working in the generics sector, innovation is key to Sandoz.

Sandoz is a global leader in generic pharmaceuticals and biosimilars. It is a division of the Novartis Group and has a portfolio of approximately 1,000 molecules covering all major therapeutic areas.