Current Approaches to Biosimilar and Bioequivalent Drugs

.: PREFACE
ÖN SÖZ
PREFACE
Prof. Dr. Sadi S. ÖZDEM
Akdeniz Üniversitesi Tıp Fakültesi, Tıbbi Farmakoloji ABD, Antalya, Türkiye
Article Language: TR
Amerika Birleşik Devletleri'nde jenerik ilaçlar için biyoeşdeğerlik verisi talep eden 1984 İlaç Fiyatı Rekabeti ve Patent Süresi Restorasyonu Yasası (Hatch-Waxman Act) sonrasında jenerik ilaçlar tıp pratiğinde oldukça geniş bir uygulama alanı bulmuştur. Biyolojik tıbbi ürünlerin üretiminde kullanılan yöntemlerde 2000'li yıllarda başlayan ve sonrasında devam eden teknolojik gelişmeler ise, bu ajanların kopyaları olan biyobenzerlerin geliştirilmesine olanak sağlamıştır. Referans konvansiyonel ve biyoteknoloji kaynaklı tıbbi ürünlere göre daha düşük maliyet ile geliştirilebilen jenerik ve biyobenzer ilaçlar, tedavi maliyetlerinde azalma ve ilaca erken erişim konusunda küresel düzeyde gözlenen talebe yanıtta anahtar bir rol üstlenmiştir.

Aynı amaca hizmet etmekle birlikte biyoteknoloji kaynaklı tıbbi ürünler ile konvansiyonel küçük moleküllü ilaçlar arasındaki fiziko-kimyasal, fonksiyonel ve immünolojik farklılıklar, jenerik ve biyobenzer ajanların onaylanma/ruhsatlandırılma süreçlerinde düzenleyici otoriteler tarafından talep edilen çalışma gereksinimlerinde önemli farklılıklara neden olmakta, biyobenzerler için jeneriklere göre çok daha kapsamlı kalite, klinik-dışı ve klinik karşılaştırma çalışmalarına gereksinim duyulmaktadır. Son yıllarda tıp pratiğine giderek artan bir şekilde giren biyobenzerlerle edinilen klinik tecrübeler, bu ajanların referans ürünlerle benzerliğini göstermeye yönelik analitik yöntemlerdeki teknolojik gelişmelerle birlikte, biyobenzerliği göstermek için talep edilen çalışma gereksinimlerinde güncellemelere gidilmesini zorunlu duruma getirmiş ve ilgili düzenleyici otorite kılavuzlarında revizyonlara gidilmiştir. Diğer taraftan, biyoeşdeğerlik çalışmaları jenerikliğin temelini oluşturmakla birlikte, belirli jenerikler Biyofarmasötik Sınıflandırma Sistemi temelinde biyoeşdeğerlik çalışmalarından muaf tutulmakta, sabit-doz kombinasyonlu, dar terapötik indeksli, nazal/inhaler, vb., belirli ilaç gruplarında yer alan jenerikler için ise biyoeşdeğerlik çalışmalarının bu gruplara özgü düzenlemeler kapsamında gerçekleştirilmesi gerekmektedir.

Bu kitapta biyobenzer ve jenerik ilaçların geliştirilme süreçlerinde yer alan çalışmalar, bu süreçlere ilişkin yerel ve global düzenlemeler ve bu alandaki güncel gelişmeler akademi, düzenleyici otorite ve sanayiden, alanlarında son derece yetkin meslektaşlarım tarafından ele alınmıştır. Çok kıymetli emekleri ve deneyimleri ile bu kitaba verdikleri katkı için her birine ayrı ayrı teşekkür ederim.

Saygılarımla.

Prof. Dr. Sadi S. ÖZDEM
Editör
Following the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) of 1984 in the United States which required bioequivalence data for generic drugs, these drugs have found a wide application area in medical practice. Technological developments, that started in the 2000s and continued later, in the methods used in the production of biological medicinal products have enabled the development of biosimilars, which are copies of these agents. Generics and biosimilar drugs, which can be developed at lower cost than reference conventional and biotechnology-derived medicinal products, have played a key role in response to the global demand for reduction in treatment costs and early access to drugs.

Although serving the same purpose, physico-chemical, functional and immunological differences between biotechnology-derived medicinal products and conventional small molecule drugs cause significant differences in the study requirements by regulatory authorities in approval/licensing of biosimilars and generic drugs, requiring much more comprehensive quality, non-clinical and clinical comparison studies for biosimilars compared to generics. The clinical experience gained with biosimilars entering medical practice with increasing numbers in recent years together with the technological developments in analytical methods to show the similarity of these agents with reference products have made it necessary to update the study requirements for demonstration of biosimilarity with resultant revisions in related guidelines of regulatory authorities. On the other hand, although bioequivalence studies form the basis for generics, certain generics are exempted from bioequivalence studies based on the Biopharmaceutical Classification System whereas, the bioequivalence studies for generics in certain drug groups such as fixed-dose combination, narrow therapeutic index, nasal/inhaler, etc. must be carried out within the scope of regulations specific for these groups.

In this book, studies for the development of biosimilar and generic drugs, related local and global regulations and the current developments in this field have been discussed by my colleagues from academia, regulatory authority and industry who are highly competent in their fields. I would like to thank each one of them for their valuable efforts and experiences, and their contribution to this book.

Best regards.

Prof. Dr. Sadi S. ÖZDEM
Editor

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