Grand Symposium: Epoetin zeta Eposan® – Possibility of Clinical Use in Kazakhstan

The Symposium On Clinical Use in Kazakhstan of Epoetin Zeta Eposan® successfully used in Europe since 2008 in thousands of patients, and introduced to Kazakh market by SANTO Company,  was conducted on January 27, in Rixos hotel.  Participants of the Symposium included representatives of the Ministry of Healthcare of RoK, leading republican medical and scientific centers, which use biological preparations for therapy in clinical nephrological practice, oncology and oncohematology.  In the course of exchange of views and experience, experts considered topical issues of epoetin zeta practical application in Kazakhstan. Director General of SANTO Company, Jiri Urbanec, spoke in his address about importance of launching of the first biosimilar by SANTO and Polpharma Group, its role in improvement of therapy access in the republican clinical practice.

As it is known, biological medicine gave new treatment opportunities in case of serious diseases: oncological pathology, diabetes mellitus, nephrological diseases, multiple sclerosis, etc. As a consequence, biological preparations significantly improved quality of life of such patients, their life time, and gave them the hope for cure. But, original biological preparations development and manufacturing process is complex and expensive, consequently, purchasing of such preparations is burdensome for majority of patients and public healthcare system in general. One of the solutions to the problem of improving access of wider population to advanced medical products s replacement of originator medicines with generics, and, in case of biological preparations, — with biosimilars.  Biosimilar is a medicine of biological origin containing an analog of active substance of a biological preparation. In addition, biosimilar demonstrates the similarity to the latter with regard to its qualitative properties, bioactivity, safety profile and efficacy based on comprehensive comparability study.

- Launching Eposan® Epoetin Zeta, we wish to confirm once again that SANTO implements advanced therapies in clinical practice of Kazakhstan by means of providing high quality and reliable European medicines –the Director of SANTO Company, Jiri Urbanec, stated in his report, - Currently, Epoetin Zeta is the first biosimilar, which was registered in Kazakhstan by our company.

Eposan® Epoetin Zeta is the license medicinal product manufactured in Spain under license of Stada Company. Epoetin Zeta received EMA registration in 2007, and is successfully applied in clinical practice in EC countries, including Germany, Great Britain, France. This is the first biosimilar of epoetin alfa, which was approved for subcutaneous administration in nephrology. Now it will be available in Kazakh market, enabling expansion of usefor gravely ill patients with chronic kidney diseases, including long term hemodialysis and predialysis patients, and patients with cancer, to epoetins therapy, simultaneously reducing cost loading on public health service budget in treatment of such grave and cost demanding pathologies.

Pharmacoeconomic characteristics of epoetin zeta biosimilar are evident and feasible benefit both for individual clinics in Kazakhstan, and for Kazakhstan health care system, in terms of reduction of load on national budget at state purchasing of epoetins.

“Indeed, according to experts, clinical and pharmacoeconomic benefits of epoetin zeta biosimilar are the guarantees of its successful launch and extensive application in clinical practice. Epoetin zeta has sound evidence base; it is comparable with reference epoetin alfa profile in terms of quality, efficacy, and safety demonstrated in pharmacodynamics and pharmakokinetics non-clinical and clinical studies, and, certainly, in III phase multicenter clinical registers, which have been performed in EC trial sites in over 900 patients in nephrology, and in over 200 patients with cancer.” – noted Dr. KClaus Martin, Director in Scientific AffairsChief Scientific Officer, Polpharma Biologics, Poland/Germany.

Professor Ian McDougall, consulting nephrologist, Head of Nephrology Studies, King’s College hospital, London, Great Britain; Dr. Klaus Martin, Chief Scientific Officer, Polpharma Biologics, Poland/Germany, Professor Morisette Mishallet, Consulting Oncohematologist, Lyon University Hospital Center, Pierre Benite, France, shared their real-life experience in the symposium, and spoke about possibility of introduction of epoetin zeta as an actual treatment option in nephrology, oncology and hematology.

Professor Saltanat Tuganbekova, M. D., Chief Visiting Nephrologist of MPH of RoK, Deputy Director of Research, National Scientific Medical Center in Astana, outlined in her report the prospects of epoetin zeta application in clinical nephrology in Kazakhstan.

Dr. Suriya Yesentayeva, Associated Professor of Obstetrics and Gynaecology, Oncology and Theriology Department of Kazakh-Russian University of Medicine, Almaty, Kazakhstan, reported about perspectives and possibilities of use of epoetin zeta in oncology in RoK. Yaroslavna Budac, Director of Pharmacovigilance and Medical Information, SANTO Company, reported on the issue of epoetin zeta application safety in Europe, and pharmacovigilance system launched in Kazakhstan immediately upon first administration of epoetin zeta.

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ABOUT SANTO:                                                                               

SANTO Member of Polpharma Group is the trade mark of Chimpharm JSC (KASE: CHFM). The Company develops, manufactures and supplies the markets in Kazakhstan and Central Asia with accessible high-quality medicines. Production capacities of the Company enable manufacturing of 1.2 bln. tablets, capsules and granules, 300 mln. ampoules, 40 mln. vials of antibiotics and 6 mln. infusion packs and vials annually. The company is the leader of the Kazakh pharmaceutical market with its portfolio including over 230 generics and original drugs in 12 therapeutic categories for treatment of diseases in various  therapeutic fields. SANTO Company is the responsible employer for over 1000 employees in Shymkent and all regions of the Republic of Kazakhstan. The Company exports out to the markets of five countries - Russia, Kyrgyzstan, Tadjikistan, Mongolia, Turkmenistan.

ABOUT POLPHARMA BIOLOGIC:

Development and manufacturing of biosimilars is the strategically important and new line of activity of the Biotechnological Department Polpharma Biologics of Polpharma Group. It is performed in the new, modern Hi-Tech park in Danzig, Poland. In its unique biotechnological laboratory, the company develops the biological preparations. Advanced universal production site meeting GMP standards is also located here. Thus, the company is engaged in development and manufacturing of biosimilars for global markets, having established an integrated organization headed by leaders with achievements in development, manufacturing, registration and commercialization of biological preparations in European Union, USA and other international markets. Biosimilars of Polpharma Biologics shall be introduced to the market in the nearest future.

Thus, in recent years patent protection validity for a series of biological preparations expires in USA, and countries of European Community that gave an impetus to many companies to commence development with further manufacturing of biosimilars of biological preparations with expired patent protection.

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ABOUT EPOETIN ZETA:

It is extremely important that epoetin zeta demonstrated immunogenic activity characteristics comparable with reference originator epoetin alfa both in intravenous, and subcutaneous  administration in patients with chronic kidney disease. Clinical registries included no hypoplastic anemia events, as severe complication, serious adverse effect of epoetins administration. This enables epoetin zeta to become the first biosimilar in the European Union, which was approved for subcutaneous administration in predialysis and hemodialysis patients with CKD.

Post-authorization, actual clinical data in efficacy and safety data are very important. PASCO-1 cohort post-marketing safety study conducted in clinical centers of four European countries in 1,634 patients with renal anemia, who have been administered epoetin zeta for 12 months, demonstrated safety profile of epoetin zeta comparable with other epoetins applied in Europe, without a single event of hypoplastic anemia. PASCO-2 extension is in progress with achievement of results in 2018.

The result of ORHEO-1 French post-marketing, observation multi-center study of epoetin zeta use in oncological practice was the conclusion concerning epoetin zeta efficacy and good tolerability in anemia therapy with concurrent administration of cytotoxic therapy in patients with solid tumors, lymphoma and myeloma. 

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