Technologies

Filgrastim, which was created at the Lithuanian Company Sicor Biotech/Teva, is moving fast into foreign markets as a result of the European Commission’s license to distribute the preparation in all 27 states of the European Union.
The oncological preparation Filgrastim, which is being manufactured by this biotech company, has been registered under the name TevaGrastim.
This preparation stimulates the immune system and promotes the creation of new white blood cells by the bone marrow. It is administered to patients following chemotherapy or bone marrow transplantation.
Scientists and industry specialists believe that the license granted by the European Union can be regarded as one of the most significant achievements for Lithuanian science and medicine in the last few decades.

Will encourage investments
The approval of this Lithuanian pharmaceutical preparation on a European scale is significant not only to the reputation of Lithuania, as an advanced biotechnological innovation centre – Sicor Biotech/Teva’s achievement will benefit both Lithuania’s scientific endeavours and its economy.
By demonstrating the enormous potential of our small country in the biopharmaceutics field, the company’s scientists showed that Lithuania’s pharmaceutical industry could be the right one for foreign investors.
This achievement coupled with the industry’s proven ability to produce high quality drugs at reasonable prices would promote knowledge-intensive subfields of science and that local industry will be able to develop at a higher pace.
It is also expected that this will help bring back Lithuania’s own highly qualified specialists who went to work abroad and in this way – end Lithuania’s brain drain.

A historical step in pharmacology
TevaGrastim is only the sixth biosimilar medicine, in other words, that complied with the original formula of drugs and the first biosimilar of Filgrastim to be registered in the European Union.
The creation of such complicated biotechnological drugs takes decades, while their clinical research stage and their complicated registration procedure may take up to several years. Other registered biosimilar medicine is used for treating HIV and other serious diseases.
Specific legal acts, enacted by the European Union, specify that medicinal preparations, which contain new active substances or that in their manufacturing process cutting edge technologies were applied, have to be registered in a centralised way for the whole of European Union.
European Medicines Agency (EMEA) experts evaluate the effectiveness and the quality of these drugs, which include preparations, intended for treating oncological diseases, degenerative diseases of the nervous system, AIDS, diabetes, and based on their conclusions the European Commission adopts a decision whether to register the drugs all over the European Union or not.

Time is required for another preparation
In their evaluation of the significance of the registration of TevaGrastim in the European Union, pharmaceutics specialists say that another Lithuanian medicine may require 10-20 years to be registered. This is obviously based on the assumption that intensive work will be carried out and sufficient financial resources will be available throughout the project.
The scientific part of the project was carried out here, in Lithuania, but we had to coordinate the activities of our employees with our partners – the companies, which carried out clinical experiments, and that all stages of the process had to comply with the strict requirements set by the European Union.

The only ones in the region
Thus far, the Lithuanian biotechnologists working for Sicor Biotech/Teva have been the only ones in Central and Eastern Europe to have begun and completed a project of such volume and significance.
Now in its third decade, the Company devoted more than ten years to this work. During that time special technology was created, pre-clinical stage experiments were carried out and the documents necessary to register the new drug were prepared.
More than 120 employees of Sicor Biotech/Teva worked on creating this preparation: microbiologists, immunologists, specialists in albumin chemistry, specialists in the manufacture of medicinal forms and biotechnological processes, as well as other scientists.
Foreign specialists experience was not needed - the majority of the employees are graduates of Vilnius University and Vilnius Gediminas Technical University.
“Biopharmaceutics appeared when it was perceived that chemical drugs did not only help but also had undesirable side effects. To reduce those effects or events, basically to eradicate them altogether attention was focussed on the processes taking place in the human organism when molecules synthesized by the organism itself become a drug”, explained Vladas-Algirdas Bumelis.
Incidentally, even after the successful completion of all these works and receiving a favourable decision from the EMEA, some Lithuanian bureaucrats tried to put a spoke in our wheels in order to prevent the registration of Filgrastim all over Europe.

Funds allocated to research
Every year, Sicor Biotech/Teva allocates around LTL 20 million to scientific research. Filgrastim is not the only medicine manufactured there. Based on the biotechnological advancements created by the company own scientists, other advanced biotechnological preparations are manufactured in Lithuania: Interferon is used to treat hepatitis B and C, as well as oncological diseases while a human growth hormone is used to treat people suffering from height problems and patients with Turner Syndrome.
It is expected that by 2020, biopharmaceutical preparations will account for 20 per cent of the world’s pharmaceutical market. Today the annual turnover of this market totals 500 billion dollars.
It is not difficult to understand that this is a lucrative and far-reaching branch of business and industry. Excellent prospects are made available for such a small country as Lithuania to enter the huge international market in this field.