Andriy Goy

Technical Director

Oct 03, 2018

Far-sightedness is a key to progress

Bioequivalence at Farmak is a standard of ethical business; a top class of evidence-based efficacy; an undeniable innovation, both for global, and domestic pharmaceutical industry.

This project has become a driver bringing our technological excellence in the manufacture of solid dosage forms to the golden standard level: we are confident that we offer generic drugs with the same proven effect as the original. Doctors ascertain this time and again and treat our products with great respect.

Was this project complicated? It was. Looking back, we can now answer the question, what brought us to success.

Ten years ago, the decision to upgrade the entire Farmak’s nomenclature according to bioequivalence standards was innovative and bold. It was a unique event for the entire industry: nobody had ever decided to invest in such a complicated and lengthy process before. More so that the regulatory authorities did not have any such requirements. Back then, it was sufficient for a pharmaceutical company launching a generic on the Ukrainian market to prove its conformity with the original through clinical studies with several dozen volunteers by way of symptomatic comparison. However, Filya Zhebrovska, Chairman of the Supervisory Board of Farmak JSC, has always set very high standards. Therefore, European requirements were adopted as a model. This required much more detailed and complex pharmacokinetic studies: studying the active substance’s ‘conduct’ in the circulatory system. Maximum standardization of all criteria for equivalence between the original and counterpart can be achieved by tracing in time and comparing concentrations of the active substance and its active metabolites in the systemic blood flow.

People, materials, process equipment, production upgrades – all this required very significant financial investment. Yet, as a result, this decision gave an impetus to a technological leap and a new level of the culture of generic development. After all, it is not just about analysis of the active substance and excipients; it also takes complex bioanalysis, considering numerous variables, and very sensitive methods. For instance, sometimes we work not even with nanograms, but with trace amounts of substances!

Eventually, a product we will offer should represent the entire target biopharmaceutical profile. This means that numerous intricacies should be considered: not only the molecule itself, but the configuration of its crystals, degree of dispersal of particles, etc. And now, what was new for us 10 years ago, has become common practice.

From the very start, the project envisaged both confirmation of bioequivalence of new drugs, and revision of the company’s existing products from a new perspective. It took place at the time. Sometimes it happened so that rework of a known medicine required more effort than creation of a generic. In any case, bioequivalence studies make the process of drug development longer. It may last for a year, year and a half, or even more. Sometimes it took dozens of batches to achieve ultimate equivalence…

Fortunately, in about 80 percent of cases the process was smooth. However, the team is not embarrassed about those 20 percent when the desired result could not be achieved from the first time, and it was necessary to refine the technology, adjust the formulation or change the study design. Such temporary failures, indicating the absence of falsifications, were evidence of transparency and reliability of our approach. Until we obtained positive results with all required statistical accuracy and full compliance with all European guidelines and criteria, we did not submit the drug for registration.

To make sure that the laboratory prototype maintains all the required parameters in the batch production, the Company created a pilot site with miniatures of technical equipment. This allows simulating and elaborating the process in every detail. Further, during commercial-scale manufacture, compliance with the set requirements is ensured by GMP standards. Thus, the art of searching, science of simulation and practical direction of engineering is supplemented with another crucial parameter: reproducibility of the excellent result. Farmak’s modern equipment allows making up to 200 tablets per second, each of them in full compliance with the target profile.

The team working on bioequivalence studies is really a cool team. Due to it, our Company has a comprehensive scientific and practical center. Doctors, candidates of science – our employees – work in the field of pure science and at the same time use its achievements to address applied problems. Among all scientists working on theoretical intelligence, our colleagues are distinguished by multidisciplinary thinking skills: the ability to design a technological process, manage the cost of components. Therefore, I am positive that in the future the potential of our team will grow.

Today, Farmak is a strong technological cluster integrating most of the modern processes used in the pharmaceutical industry at the commercial level. Therefore, its task is to be the leading center of pharmaceutical technology and to quickly adapt unpatented innovations, reduce their cost due to sophisticated decisions, and make modern pharmacological therapy affordable. This is a very significant contribution to the healthcare system of Ukraine, as well as other countries, where Farmak has a presence.

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