Publications

AstraZeneca has become a Pharmaceutical Partner of the 5th…

Global Pharmaceutical Leaders’ Club announces that AstraZeneca has joined the Eurasian Pharmaceutical Summit 2024 as a Pharmaceutical Partner. 

AstraZeneca stands at the forefront of the biopharmaceutical industry, driven by a commitment to science and innovation. With its headquarters in the UK, this global powerhouse is dedicated to discovering, developing, and commercializing prescription medicines in oncology, rare diseases, and various biopharmaceutical sectors, including cardiovascular, renal, metabolism, respiratory, and immunology. Operating in over 100 countries, AstraZeneca’s trailblazing treatments improve the lives of millions of patients around the world.

Detailed information about the company.

Publications

Maria Shipuleva: “We would like to expand the dialogue…

Maria Shipuleva, Head of AstraZeneca’s Representative Office in Kazakhstan shared the company’s priorities in the country with Natalia Baeva, Director of the Global Pharmaceutical Leaders’ Club. They discussed the company’s direction in Kazakhstan and ways to enhance market regulation efficiency to expand patient access to innovative medicines. The interview was taken at the Kazakhstan Pharmaceutical Forum. AstraZeneca will participate in the Eurasian Pharmaceutical Summit, which focuses on market trends in Central Asia, the Caucasus, and Eastern Europe. The dialogue with regulators from various countries, including Kazakhstan, will continue at the summit.

Natalia Baeva, Director of the Global Pharmaceutical Leaders’ Club: What trends do you see in the Kazakhstan market and what priorities do you set for your company in the current conditions?

Maria Shipuleva, Head of AstraZeneca’s Representative Office in Kazakhstan: In 2023, AstraZeneca’s workforce in Kazakhstan more than doubled, and we entered 2024 with a robust team of 200 employees. However, we are not stopping there; growth remains our focus. To solidify our presence, we registered an LLP in September 2023, paving the way for long-term collaboration with the state and various market associations. In 2024, we will transition to full-fledged LLP operations, including opening our own warehouse to reduce logistics dependency and ensure reliable medicine supply.

2023 underscored the importance of innovative healthcare in Kazakhstan, with numerous regulatory documents signed to boost the presence of innovative companies. A key focus is contract manufacturing within Kazakhstan, and we are already progressing towards this goal. We aim to sign a contract manufacturing agreement this year to start technology transfer and local production by 2025 – an ambitious but achievable timeline.

We are also initiating steps to include patients in Kazakhstan in clinical trials, marking the first time local patients will participate in phase 3 trials. Additionally, we plan to launch at least four real-world evidence studies in 2024. 

Expanding cooperation in diagnostics is critical for us. We have a longstanding commitment to oncology and orphan diseases in Kazakhstan, and we are poised to increase our contributions in these vital areas.

Natalia Baeva, Director of the Global Pharmaceutical Leaders’ Club: As an innovative company, what improvement opportunities would you discuss with regulators? Where do you see potential in Kazakhstan to make medicines more accessible to patients? 

Maria Shipuleva, Head of AstraZeneca’s Representative Office in Kazakhstan: We would like to keep strengthening the dialogue between business and government in Kazakhstan. While this dialogue is ongoing, closer cooperation is essential. Regulation here is evolving quickly, so we must focus on upcoming changes over the next few years. Our industry is particularly concerned about the harmonization of pharmaceutical drugs registration certificates. We as an industry faced challenges with document compliance in the past, so we need clear communication to minimize the risk of medicines shortages.

Another urgent matter is the labeling of unregistered pharmaceutical drugs, which could hinder access for orphan patients, especially minors. It’s crucial to ensure these essential medicines can be imported without unnecessary hurdles.

Natalia Baeva, Director of the Global Pharmaceutical Leaders’ Club: What were your takeaways from the forum? How does your company benefit from participating in such gatherings?

Maria Shipuleva, Head of AstraZeneca’s Representative Office in Kazakhstan: Your platform facilitates vital communication between industry and government bodies, enabling us to exchange experiences, expectations, and concerns. Without such forums, our opportunities for dialogue would be limited. It’s crucial for us to hear the regulator’s position and understand the approach. Equally important is for the regulator to grasp the intricacies of doing business, including not just long-term strategy but also specific proposals for smoother collaboration with the industry.

With participation from both innovative companies and manufacturers of dietary supplements and generics, these forums offer a unique opportunity to collaborate on long-term regulatory improvements. Together, we can explore avenues to enhance regulation for the benefit of all stakeholders.

Publications

Tatiana Kubasova, Business Development & Frontier Markets Director, AstraZeneca,…

In the dynamic landscape of the pharmaceutical industry, companies that adapt to changing priorities and embrace innovation are poised for success. AstraZeneca, a global leader in the field, has a presence in over 100 countries worldwide, including the diverse markets of Eurasia. Regardless of location, AstraZeneca remains steadfast in its core mission: making innovative medications more accessible to patients.

Today, we have the privilege of speaking with Tatiana Kubasova, Business Development & Frontier Markets Director, AstraZeneca, Russia and Eurasia. She shares insights into the company’s priorities in the Eurasian region, where they see the most promising opportunities, and the pivotal role they play in enhancing patient lives.

Let’s delve into Tatiana’s perspective on AstraZeneca’s strategy and the evolving pharmaceutical landscape in Eurasia.

What are the priorities for your company in the Eurasia region? In which countries and what segments do you see the most prospects for your company?

Today AstraZeneca operates in over 100 countries. In each region the company is focused on creating genuinely innovative medicines and improving access to them. There are millions of people suffering from cardiovascular disease, cancer, and other serious chronic diseases in Eurasia. We firmly believe that modern therapies can improve the quality and life expectancy of these people.

AstraZeneca’s presence in Eurasia comprises Russia, Belarus, Kazakhstan, Uzbekistan, Mongolia, and we’re constantly working to develop our presence in this region. Having started operations in Uzbekistan in 2021, we managed to register several medicines for the treatment of cardiovascular disease, chronic obstructive pulmonary disease, and bronchial asthma. Our next step is to offer the treatment for rare diseases, oncology and oncohematology for patients in Uzbekistan. Above all, we continue to update the existing pipeline with the new indications.

What trends having the most impact on pharmaceutical markets in the countries of the Eurasian region do you highlight for your company?

Today we are witnessing a significant growth in EAEU markets where the pharmaceutical industry was not much developed before, including Uzbekistan. It is due to the low base effect that the market is not yet saturated with the new drugs, which makes it attractive for international companies. We expect the highest growth of the Uzbekistan pharmaceutical market in the next few years.

It is very important to note that the market growth without proper regulation can become dangerous for patients. Hence low-quality medicines can freely enter pharmacies, leading to possible adverse events for the citizens. Therefore, despite the existing prospects, international investors will not be ready to enter the market, given the absence of proper control and compliance for all market players. In this regard, there is an urgent need not only to apply all international requirements and rules of the pharmaceutical industry in Uzbekistan, but also to constantly monitor their compliance. That is why it is necessary to solve the industry regulation issue at the government level, which would ensure the safety of medicines.

What planned regulatory changes may affect the development of the pharmaceutical markets in the Eurasian region?

There is no doubt that the introduction of pharmaceutical drug labelling will have a significant impact on the region’s pharmaceutical market. Russia was the first country in Eurasia to introduce the drug labelling. Therefore, companies that have experience in working with the Russian labelling project will have a technological advantage in other Eurasian markets.

As for Uzbekistan, we expect strengthening of the government regulation in terms of certification and distribution since decent pharmaceutical logistics and distribution is impossible without the abidance by the Good Distribution Practice (GDP) rules, especially considering the region’s climate. Undoubtedly, it is also important to toughen the responsibility of pharmacies for the sale of low-quality and counterfeit medicines.

We are also awaiting the speedy introduction of a health insurance system in Uzbekistan. This will enable a successful investment in the modernization and expansion of the medical care services from diagnosis to access to medicines. Today, patients in Uzbekistan must pay for some services and medicines, which can affect diagnosis and medical care, hence a patient may simply not buy the necessary medication, and therefore not start their treatment. As a result, this may lead to the disease progression and become a heavy burden for the healthcare system in general. That is why we believe that pharmaceutical industry representatives cannot be excluded and must be involved in the pilot projects to boost the timely implementation of the health insurance system in Uzbekistan.