Read the Conversation
Conversation highlights:
- Market Dynamics & Policy Shifts: 2025 brought significant volatility driven by price controls, geopolitical events, and power shifting toward regional clusters, alongside faster registration pathways and new health leadership across key markets.
- Regional Focus & Partnerships: A priority for 2026 is deepening understanding of evolving regional dynamics, strengthening collaboration with governmental and procurement bodies, and positioning emerging hubs as centers for investment, research, and innovation.
- Portfolio & Therapeutic Opportunities: Strong momentum in new therapies, especially in rare diseases (Friedreich Ataxia), Alzheimer’s (early diagnosis), Spinal Muscular Atrophy, and Post-Partum Depression, where treatment gaps remain substantial.
- Access, Regulation & Economics: Rapid registration, economic stability, long-term planning, and competitive pricing environments are key advantages; ensuring patients receive treatment quickly once access is granted remains essential.
- Leadership & Industry Evolution: As the healthcare ecosystem grows more complex, success depends on science-driven engagement and team-based leadership, shifting from individual to collaborative “basketball-style” performance.
EF: How do you reflect on 2025, and what are the highest priorities for you in 2026?
DK: 2025 has been a very dynamic year. To begin with, President Trump was inaugurated in January; one of the things specifically under Trump is the most-favored-nation (MFN) recognition, and the tariffs, which shocked the whole industry. The effect is that every price, whether at Biogen or at any other company, now gets added scrutiny at headquarters. If you want to introduce a new product, you need to know the price, even in small markets like Bahrain. They are not aware of how big Bahrain is, but they still want to know its prices because they could be lower than in the US.
Another factor influencing the region is the lower oil price. Governments, specifically in Saudi Arabia as we are seeing, are tightening their belts and thinking about whether they should spend and on which projects. They have been delaying some tenders, and we faced some headwinds there. Same in Oman. We were just informed that the tender at the end of the year has been postponed to next year. Kuwait as well. So, there is a lot of turbulence in the market.
Another thing, specifically in Saudi Arabia, is the whole healthcare transformation, where we see the balance shifting from the centralized Ministry of Health to the clusters and the Health Holding Company. We are still in the middle of this, which is causing uncertainty in Riyadh regarding who is approving of what. So, there are a lot of interesting dynamics happening in the region. And on top of that, all the companies, including Biogen, are bringing new products and innovations to the area.
There are also many positive things, for example, fast-track registrations. At Biogen, we got a product approved within four months in the Saudi FDA, the fastest they have ever done from filing to pricing , to our understanding. This is evidence that the country is changing. We also had fast-tracked registrations in the UAE, but that has always been fast. Specifically on the stakeholder side, the Emirates Drug Establishment (EDE) is still relatively new, but paving the way rapidly; this is the first year with unified procurement. There is a new Minister of Health in both Qatar and Kuwait, adding to a dynamic landscape for 2025.
Looking ahead to 2026, one of our key priorities at Biogen is to understand and anticipate the evolving situation in Saudi Arabia, especially since NUPCO, the centralized procurement body, has changed its approach. Previously, there were two-year tenders with predictable delivery schedules; now the system involves one-year tenders with varying terms and conditions, making it less predictable.
We want to understand what this means for our business. We are already in discussions with NUPCO. And signed an MOU with the purpose of developing a framework for rare disease procurement and assurance of supply. As an example, we have a product with 15 patients in Saudi Arabia. If it reaches 20 and we haven't produced the extra product, there’ll be questions about the shortage. However, if we prepare for 20 patients and only 15 need treatment, the excess goes to waste, resulting in losses. Rare diseases need a tailored approach, which is already designed by the Saudi FDA. Another thing we are doing at Biogen is bringing multiple clinical trials to the region.
We have an exciting portfolio of future products, specifically in immunology. Several promising trials are starting in that area. 2026 will also be the year we have BIO in Riyadh, bringing a traditionally US- and European-focused event to the Middle East. This is an opportunity to showcase all the opportunities here in the region to the world.
If you consider the broader Middle East, Levant, and North Africa, you are referring to a population of about 300 million people. There are many opportunities for companies to come to the region, invest, conduct clinical trials, and conduct research. And it is a growth region, one of the fastest growing, specifically compared to Europe or some APAC countries. Furthermore, it’s a region with a high prevalence of rare diseases, specifically in Saudi Arabia, which brings the urgent need to bring innovation as fast as possible to patients.
EF: How do you assess the approach to bringing new therapies to market?
DK: One of the challenges is the speed at which we can obtain regulatory approvals, since in some countries this process can take multiple years. Another part is the market opportunity. The prevalence of certain rare diseases is much higher on the Arabian Peninsula than in Europe or the US. Although the region has about sixty million people, the proportionate number of people affected by rare diseases is much higher here than in Europe and the US. So that is the first step: the size of the opportunity, the unmet need, and then our moral and patient-centric obligation. If there are many patients, we need to prioritize these countries.
The second step is the regulatory pathway: how fast it is to get approval. Then pricing is relevant, specifically with the US MFN. And then comes market access. There is a difference in the region. In the UAE, once you are approved, every local citizen in the country has access. In Saudi Arabia, the transformation might take some time. That is an area of opportunity for Saudi Arabia. Once we have access to the market, we want to ensure patients receive treatment as quickly as possible, especially in rare diseases, as each day we wait, a patient might deteriorate further.
In the long-term assessment, there is regulatory data protection and patent protection. In the UAE, there are now eight years of regulatory data protection. The EU has up to eleven years, eight years of exclusivity, and 2 years of Marketing protection. To ensure consistency, we should consider aligning our standards to up to eleven years as well, as that would make the country more attractive. Saudi Arabia has five years. That presents an opportunity for the region, having fast registration and competitive US prices. If the duration of patent protection or regulatory data protection extends, then the return on investment is higher, and companies will have more long-term predictability. So, apart from the short term, the question is, how long can we stay in this market?
EF: Could you tell us about the disease areas you are working in and the pipeline?
DK: Maybe first about Alzheimer’s. It is a devastating disease. The problem is that once you reach a certain point, it is too late. There are no more treatment options. It is crucial to diagnose and treat early. We are working on awareness in the region. There are a lot of stigmas. The most significant opportunity is to recognize the early signs and symptoms, ensuring that individuals can benefit from available treatments while they are still effective.
If you look at Alzheimer’s, there are over 180 compounds in the pipeline from multiple companies. There is promising innovation coming into this disease area. And now, finally, there are treatments available in the GCC, so we can start addressing it. Biogen has multiple compounds, not only the current one, but also new compounds in development.
The other valuable space is spinal muscular atrophy. There are three manufacturers in that area. There are still many patients in the region who have not been diagnosed. Biogen is launching two new products, one in the short term and one in the long term, to continue addressing SMA and to ensure that patients have a choice, that they do not deteriorate further, and might even stabilize.
We are also working on a product for postpartum depression. Biogen has the first treatment for it in the US. We are now evaluating introducing this offer to the GCC region, as we have identified a clear market need. It is an innovative, rapid relief 14-day course of treatment, and it should really make a big difference. Many women are using this treatment in the US with promising results.
EF: From a leadership perspective, what kind of people are you looking for at Biogen? What kind of skills do they need to adapt in this ever-changing world?
EF: You need people who can work cross-functionally, who trust each other, because you cannot know everything. It is a complex industry. Pharmacovigilance, quality, regulatory, I am just naming a few. Most people don’t understand the supply chain. You need to work with legal, compliance, commercial, and medical. Nobody can control all of those areas, so you need to work as a team.
If you observe a basketball team, the favorite sport of my son, it is not important who scores. We need to trust the other players. So, I am looking for basketball players. I work with someone who is the best in regulatory, and they will tell me what is important to me in this partnership or project. And that will become increasingly important as many parts of the industry have become more complex.
Compliance is also crucial. Every year, we raise our compliance standards. It's important to trust our compliance team to guide us. In the past, we would send many people to the US to attend a congress. Now, you can choose from three options: travel independently, participate online, or receive a detailed report. With AI tools, you can get a full summary of the convention with just a few clicks. There’s no need for the old way. Still, there are new and meaningful ways we can engage and bring scientific knowledge to you.
