Joaquin Rodrigo, general director of Sandoz Spain and Portugal, introduces the company’s highly diversified generics and biosimilars portfolio in the region, gives his thoughts on Spain’s generics market, and outlines the rationale behind the creation of a national biosimilars association, BioSim.

 

Can you please start by introducing Sandoz and its presence in Spain?

Sandoz is a highly diversified company in Spain, with a strong mixture of generics and biosimilars in our portfolio. Our portfolio is extremely comprehensive, and we are one of the key players in the biosimilars market. I manage both the Spanish and the Portuguese affiliates, which employ over 200 people.

In Spain, we also have Sandoz Industrial, focusing on producing APIs for anti-infectives, which are distributed all around the world, including Spain.

 

What is your assessment of the Spanish generics market?

In Spain, there is a huge opportunity ahead of us in terms of penetration of both generics and biosimilars. It is clear that the generics market is a mature market, so the growth opportunity lies with biosimilars. We expect that the new government will revitalize current policies and that they will be very receptive to further promoting generics in Spain. Our country currently ranks below the European Union average for utilization of generic medicines.

Furthermore, this lack of penetration of generics in the Spanish market is due to the absence of a clear price difference between the reference medicine and the generic product. Looking at other European countries that have experienced success with generics entering the market, you can see that there was always a significant difference in price. Before the crisis, we had this difference in Spain, but since this has disappeared, sales of generics in the market have stagnated. Many other countries have experienced more competition and stakeholders across the whole healthcare sector value chain have benefitted. We would like to imitate those examples in Spain as well.

 

How has this market evolved since you became general manager?

Since I became general manager of Sandoz over four years ago, the main development has been the level of interest in biosimilars. This area of the market is a focus topic and since the loss of patents of big, biological products there is now a lot more interest in biosimilars. In 2006, Sandoz was the first company to commercialize a biosimilar in Europe including Spain, which was a growth hormone. However, the biosimilar market only really started to take after following patent expiries for several big molecules.

At Sandoz, we have no difficulty discussing the topic of biosimilars because it is easy to liaise with key stakeholders and we make the most of this openness. BioSimilars could really improve the Spanish healthcare market, but this depends on how all those involved come together. It is vital that we avoid the mistakes the country made when generics were introduced to the market, such as misconceptions and false perceptions of products. In the past, many thought generics were lower quality and not of the same standard as the reference medicines. We have to avoid a repetition of these perceptions for biosimilars. The idea is to involve the whole value chain right from the beginning and to shape the biosimilars landscape in the country. This is the main idea behind the creation of BioSim [the Spanish biosimilars association – Ed.], of which I have been president since its creation.

 

What was the reasoning behind the creation of BioSim?

BioSim ensures the participation of all companies that have a current or future interest in establishing biosimilars, whether that is manufacturing or commercialization. It is a big accomplishment to now have 16 companies involved and contributing to shaping the environment. I feel that the industry cannot be excluded from the decision making process. BioSim raises the industry´s voice to the government and the other agencies involved, including administration, regulators, physicians, nurses and pharmacists.

We are proud to have created BioSim, because we are the first association dedicated to the implementation and awareness of biosimilars. As a Spanish citizen I am pleased to see that we are breaking frontiers! Our country is probably 10 years ahead of other regulators because we see a lot of expertise in the regulatory field in Europe.

The main change Sandoz is striving for through BioSim is to establish a price difference between the biosimilar and its reference medicine. Without this difference, companies will struggle to successfully launch a biosimilar product and find their place in the Spanish market. Without a strong incentive to healthcare systems it will be difficult to promote biosimilars.

 

What is the main potential of generic products when introduced into the market?

The main advantage of generic and biosimilar products is their efficiency. When a generic product enters the market, there is an immediate 40 percent price decrease and biosimilars see a 20 percent price decrease. Looking to the future, these savings will be substantial for the system, and I think the administration understands the importance of this.

Although we are focused on research, production and manufacturing of generic medicines, generic companies should be welcomed as a strong partner of the healthcare sector because their portfolio brings efficiency to the system.

Spain is one of the biggest countries in Europe and we must play our role in the development of biosimilars. There are a lot of experts in the EMA (European Medicines Agency) who come from Spanish agencies. We see a significant amount of talent with a background in biosimilars in AEMPS (Spanish Agency of Medical and Sanitary Products) under the leadership of Belen Crespo.

 

At Sandoz, what is the main difficulty of operating in Spain?

It is well known that in Spain there are 17 autonomous communities that manage their own healthcare budget and policies. Regarding market access, you must be capable of interacting with each of these different communities because there is no single market access team at a national level. We have a team consisting of six people working at a regional and hospital level to develop market access strategies and ensure that our operations in the country are as efficient as possible. This approach is unique, but one has to adapt and diversify operations if needed, and so far, we have been successful.

Our main competition in Spain is not only coming from international companies, but also from national generics companies. Out of the five most important generics players in Spain, three of them are national companies. This is a unique market in Europe. To differentiate ourselves against local competitors we need to maintain a strong patient focus.

 

Looking towards the future, what are your main priorities?

Moving forward, biosimilars will remain our number one focus and we will continue to strive to become a leader in this area. Looking at other opportunities within the healthcare system, the OTC segment is an area we can capitalize greatly on, mainly due to the shift towards prevention-type medications. This is a trend we are prepared for and we expect interesting growth opportunities. .

Furthermore, I want to keep up the positive momentum of our employees and further develop Sandoz as one of the best places to work. Most recently, we were certificated with the ‘Great Place to Work’ award, an amazing recognition, especially because it is conducted through a survey completed directly by the employees. Here at Sandoz, we work with a lot of passion and our culture is derived from focusing on patient needs. . At Sandoz, we work hard but we also have a lot of fun and give back to the societies we operate in.

 

More on a personal note, what keeps you motivated day-to-day?

My biggest motivation, but also the greatest challenge of being a general manager, is to manage and motivate our employees. I try to surround myself with the best people to create the best working environment for our associates to grow in their roles.

I strongly connect to Novartis’ mission, which Sandoz purpose derives from this: to pioneer novel ways to drive access to high-quality medicines. Although simple in its core it is a great but rewarding challenge to create this access every day to help improve the lives of patients.