In the last two years, the leading Baltic pharmaceutical company JSC Olainfarm has already submitted 21 new products for registration in total to 10 European Union (EU) countries, for 17 of which the registration process started last year. It is planned that this year the registration process will start for at least 20 more medicinal products.

The largest number of new medicinal products registrations have started in Germany – 18. While 16 new preparations are in registration in the Baltic States, Spain and Poland. In Italy the proceeding has been commenced for 15 new products, but in France – 14. Olainfarm has already approved more than 50 patent-free medicines in the new product portfolio, for which, according to the market situation and also the available registration submission times, according to the schedules of the competent authorities, registration has been started in various markets of the Western European countries.

“Last year has been very dynamic for us. In 2022, we submitted four new products for registration on the EU markets, and in 2023 – already 17. On average, the registration of one product lasts for almost a year and a half, and in this process we should be ready to promptly submit additional information about the quality, clinical research and safety of the developed medicine. There is a story of the team’s determination and passion behind these number, because in a very short period of time we have not only created a new product portfolio, but also conduct an intensive registration process for a number of products. The target of Olainfarm is to become one of the 10 leading pharmaceutical companies in Europe in its therapeutic groups, and the registration of each new medicinal product brings us closer to this strategic goal,” emphasizes Jeļena Voļperte, Head of the Registration Department of JSC Olainfarm.

The new medicines are both in the existing and new therapeutic groups of JSC Olainfarm – neurology, cardiology, urology, oncology, as well as medicines against allergies, infections and diabetes.

In 2023, the company already successfully completed the registration of a new antibacterial medicine used in urology in Latvia, Lithuania, Estonia, the Czech Republic and Slovakia, as well as the registration of a new cardiology product in Latvia, Lithuania, Estonia, Slovakia, France and Spain. Commercialization of these products will begin in the middle of this year, according to the requirements and the price registration process. Besides, registration certificates have been received for endocrine therapy medicines in Spain, the Czech Republic, Slovakia and the Baltic States.

At the same time with the change of the majority of shareholders, which was completed only at the end of 2021, the company reviewed its development strategy, focusing on the development of a new product portfolio in the segment of patent-free medicines, which would be competitive in the Western European and global markets. Latvian patients will also benefit from this, due to the fact that upon expansion of the offer in the patent-free medicine segment, competition and price pressure for original preparations increase.

“At a time when the government has approved the report of the Ministry of Health on the financial availability of medicines, the question of what instruments will be used to promote market development in the long-term perspective, in order to create competition for imported original preparations, has undeservedly remained in the background. The import of foreign manufacturers in the Latvian medicine market accounts for 94%. Therefore, the role and competitiveness of local medicine manufacturers should be strengthened. A wider offer of patent-free medicines provides doctors, pharmacists and the patients with more possibilities of choices for themselves, due to competition also lowering their prices and thereby promoting the availability of medicines and reducing the risks that a number of imported medicines may not be available for Latvia in emergency situations. Currently, for a number of diagnoses, only medicines produced by a specific foreign manufacturer are available in Latvia, creating some kind of monopoly. Therefore we also make large investments in our product portfolio in order to become more competitive both internationally as well as in Latvia,” says Juris Bundulis, the Chairman of the Board of JSC Olainfarm.

JSC Olainfarm has devoted all its efforts and resources for the past two years to prepare a portfolio of products suitable for the markets of Western countries, as well as to register these products as soon as possible. For this purpose, in 2022 and 2023, the total investment in new products was 12 million euros, but in 2024 it is planned to invest at least another 22.25 million euros and in 2025 – 16.2 million euros.