ACCESS TO BIOLOGICAL THERAPY IN KAZAKHSTAN: REALITY OR FUTURE?
An expert conference “Access to Biological Therapy in Kazakhstan: Reality and Future” will be organized by Biosimilar Expert Alliance NPO with the support of SANTO company which was conducted in Astana on May 17. Participants included representatives of regulatory authorities, non-profit organizations, pharmaceutical companies, and clinical experts, who discussed issues regarding regulation, availability and circulation of antibiotics and biosimilars in the RoK, and issues encountered in clinical practice(s).
In his welcome speech, the Chairman of Biosimilar Expert Alliance, Talgat Seitzhanovich Nurgozhin stated that the Alliance was established for the purpose of solving topical issues in the field of medicine and to introduce modern medical approaches into clinical practice. The development and production of originator specimens for antibiotics is a complex and costly process, so purchase(s) of such medicines is usually burdensome for the majority of patients and the healthcare system in general. One of the ways to solve the challenge is by increasing the availability of modern medicines for the population at large is the substitution of original prescription drugs with generics, as is the case with antibiotics or with biosimilars. Biosimilars are highly similar to reference antibiotics by their qualitative characteristics, safety and efficacy as validated by in comparative clinical studies. It is also worth noting that not every unlicensed antibiotic is biologically similar, only those that have passed strict regulatory approval process based on substantive testing when comparing the characteristics for quality, efficacy safety, and immunogenicity resulting in lack of any significant difference in therapy outcome. To the contrary, antibiotics, which failed to pass strict comparative analysis are intentional copies in accordance with WHO guidelines and are circulated in healthcare systems of certain countries. The risk of use of such “copies” consists in lack of any efficacy and safety data, (i.e. unpredictability of the clinical outcomes).
In January 2017, the SANTO company presented epoetin zeta, which is a generic version of epoetin alfa registered in the European Union in 2007, and has been successfully used in Europe since 2008 to treat thousands of patients. Its use facilitates the availability for biological treatment for patients with chronic kidney diseases as well as oncologic patients (cancer patients).
With the registration of “epoetin zeta Eposan®”, we are taking a new step on the road to higher-quality and more readily accessible medicine(s) having reconfirmed that SANTO has introduced an advanced treatment method into clinical practice(s) of Kazakhstan by providing high-quality and more effective pharmaceuticals from Europe,” – highlighted Irina Chublukova, the Head of the Special Medicines Department at SANTO company.
The expert confrence was opened by Larisa Yun-Boyevna Pak, the acting Chairman of the Pharmacy Committee for the Ministry of Public Health of the RoK, who talked about the current status and activities aimed at improving the existing healthcare system, and advised everyone in attendance to be proactive, by contributing their suggestions concerning the improvement of a pharmacological support system. In addition, she also emphasized the timeliness of the issue(s) of biological therapy, and the capabilities for use in the treatment of refractory diseases.
Shynar Amanovna Baidullayev, the Deputy Director of the National Center for Expertise of Medicines, Medical Devices and Medical Equipment, reported on matters regarding the availability of biologics and biosimilars and their circulation in RoK. Sandzhar Kasymovich Uralov, the Managing Director of SK-Pharmacy LLC, mentioned in his report the direction of the single distributor system transformation. Problems regarding access to biologics in RoK from the viewpoint of clinicians were highlighted in reports made by Saltanat Kenesovna Tuganbekova and Rayfa Latyfovna Ivanova. Irina Chublukova, the Head of the Special Medicines Department at SANTO company, and Aigul Zhumanova, the Director of the representing office for Egis Pharmaceuticals CJSC in the Republic of Kazakhstan, presented reports regarding the role of biosimilar producers and expansion of access to biological therapy and their efficient use.
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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 in Central Asia with accessible high-quality pharmaceutical products. The production capacities of the Company enable manufacturing of approximately 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 200 generics in 12 therapeutic categories for the treatment of diseases in various therapeutic fields. SANTO Company a responsible employer for over 1000 employees in Shymkent and other regions within the Republic of Kazakhstan. The Company has developed export versions of its products into countries such as Turkmenistan, Kyrgyzstan, Mongolia, Tajikistan, Russia, and Ukraine.
ABOUT POLPHARMA BIOLOGICS:
The development and production of biosimilars is a new and strategic activity for the biotechnology division of Polpharma Biologics, Polpharma Group. We are currently based in a new modern Hi-Tech park in Gdansk, Poland. The company develops biologics in its unique biotechnological laboratory. The up-to-date multipurpose production site is equipped in accordance with GMP standards. Thus our company is engaged in the development and manufacturing of biosimilars for global markets, having created an integrated organization managed by leaders with success in development, production, registration, and commercialization of biologics in the European Union, USA, and other international markets. The biosimilars of Polpharma Biologics will be introduced to market in the near future. Current patent protection for a number of biologics in USA will be expiring soon which has become the stimulus for many companies within the EU to develop and produce of biosimilars from biologics with expired patent protection for distribution in generic formats.
ABOUT EPOETIN ZETA:
Eposan® (Epoetin Zeta) is the medicinal product manufactured in Spain under the license of German Stada Company. Epoetin Zeta received EMA registration in 2007, and is successfully applied in clinical practice in EU countries, including Germany, Great Britain, France. It was developed in accordance with rigorous EC criteria for quality, efficacy, and safety which was confirmed by extensive pre- and post-clinical studies. It is of high importance that epoetin zeta has demonstrated its immunogenicity capabilities comparatively with those of reference originator epoetin alfa both by intravenous, and subcutaneous administration in patients with chronic kidney diseases. No cases of pure red cell aplasia (PRCA), which is the severe compliation and serious adverse effect of epoetin administration, were reported during the registry clinical studies. This enabled epoetin zeta to become the first biosimilar approved in the EU for subcutaneous administration in hemodialysis and pre-dialysis patients with chronic kidney diseases.
Post-authorization efficacy and safety data received in real clinical practice are of importance. Cohort post-authorisation safety study PASCO-1 conducted in clinics of four European countries in 1634 patients with renal anemia, who received epoetin zeta within 12 months, demonstrated safety profile of epoetin zeta comparative with other epoetins used in Europe, without any case of PRCA. Further study PASCO-2 is continued with results expected in 2018.
The result(s) of post-authorisation observational multicenter study of epoetin zeta used in oncological practice ORHEO-1 conducted in France was the conclusion concerning efficacy and tolerance of epoetin zeta in the treatment of anemia associated with cytotoxic therapy in patients with solid tumors, lymphoma and myeloma.
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For more information, please contact to:
Tatiana Filipchik, PR-manager
SANTO Company
Address: 19 floor, block 5B, Nurly-Tau PFC, 17/1 Al Farabi Ave., Almaty 050013, Kazakhstan Tel.: +7 (727) 3121833
e-mail: tatyana.filipchik@santo.kz
www.santo.kz