Journal of Literature Pharmacy Sciences

Biyobenzer İlaç Pazarı, Politikaları ve Güvenliği
Drug Market, Policy and Safety of Biosimilars
Kübra İrem TETİKa, Onur Kenan ULUTAŞb, Suna SABUNCUOĞLUa
aFarmasötik Toksikoloji AD, Hacettepe Üniversitesi Eczacılık Fakültesi,
bFarmasötik Toksikoloji AD, Gazi Üniversitesi Eczacılık Fakültesi, Ankara, TÜRKİYE
J Lit Pharm Sci. 2019;8(2):119-27
doi: 10.5336/pharmsci.2018-63436
Article Language: TR
Full Text
ÖZET
 Biyoteknolojik ilaç üretimi, ilk kez 1982'yılında insülin üretimi ile başlamış olup; büyüme hormonları ve çeşitli enzimler, interferon türevleri, eritropoietin ve koagülasyon faktörleri, aşılar ve tümör hücrelerinde bulunan çeşitli hedef moleküllere yönelik geliştirilmiş monoklonal antikorlar üzerinden devam etmektedir. Biyoteknolojik ilaçların dünya ilaç pazarındaki yerinin 2000 yılında %10 seviyesinde olduğu görülürken, 2014 yılında %20 seviyesine ulaşmıştır. Biyobenzer (biosimilar) ürünler ise önceden ruhsat almış bir biyofarmasötik ürün ile oldukça benzerlik gösteren biyolojik ilaçlardır. Biyobenzer ilaçlar 2010 yılında, biyoteknolojik ilaç kategorisi içinde neredeyse hiç bulunmaz iken, 2016 yılında oranları %13,4'e çıkmıştır. İlk ruhsatlanan ana kaynak (referans) biyoteknolojik ilaçların patent geçerlilik dönemlerinin bitmesiyle birlikte ilerleyen dönemlerde biyobenzer yapıda ürünlerin sayısının hızla artması beklenmektedir. Jenerik ilaçlardaki biyoeşdeğerlik kavramı kimyasal olarak sentezlenen ilaçlara uygun olup, üretim yöntemlerine bağlı olarak biyobenzer ürünler için söz konusu olamamaktadır. Bu yüzden biyobenzer ürünler için yapılan kıyaslanabilirlik çalışmaları, referans ürün ile biyobenzer ürün arasındaki kalite, güvenlik ve etkililik bakımından karşılaştırılmalarına dayanmaktadır. Bu çalışmada Avrupa Birliği ve Türkiye'de biyobenzer ilaç pazarının son durumu, biyobenzer ilaçlar ile Türkiye'de gerçekleştirilmiş klinik çalışmalar, biyobenzer ilaçlar için düzenleyici kuruluşlara yapılan başvuru süreçleri, biyoteknolojik ve biyobenzer ilaçların birbiriyle ile değiştirilebilirliği, güvenliliği konularına yer verilmesi amaçlanmıştır.

Anahtar Kelimeler: Biyobenzer; biyobenzer ilaç pazarı; immünojenisite; değiştirilebilirlik; güvenlik
ABSTRACT
 Biotechnological drug production was first started in 1982 with insulin production and continued through growth hormones and various enzymes, interferon derivatives, erythropoietin and coagulation factors, vaccines, and monoclonal antibodies for various target molecules found in tumor cells. While the place in the world pharmaceutical market was 10% in 2000, it reached 20% in 2014. Biosimilar products are biological drugs that are very similar to a previously licensed biopharmaceutical product. In 2010, biosimilar drugs were almost absent among biotechnological drugs, while in 2016, their market share raised to 13.4%. With the expiry of the patent protection of original biotechnological drugs, the number of biosimilar products is expected to being increase rapidly in the future. The concept of bioequivalence in generic drugs is suitable for chemically synthesized drugs and is not subject to biosimilar products depending on production methods. Therefore, comparability studies for biosimilar products are based on comparisons between the reference product and the biosimilar product in terms of quality, safety and effectiveness. In this article, the existing position of biosimilar drugs market in Turkey and European Union, clinical studies have been carried out in Turkey, application processes for regulatory agencies for biosimilars drugs, interchangeability of biotechnological and biosimilar drugs, safety issues are comprehensively evaluated.

Keywords: Biosimilar; biosimilar drug market; immunojenesity; interchangeability; safety
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