Current and future roles of biosimilars in oncology practice (Review)

Abstract

Biologics have been used increasingly in the treatment and supportive care of cancer; however, their high cost places a significant burden on healthcare systems. The expiration of patents for biologics has led to the development of biosimilars, with the aim of reducing cost and increasing accessibility to novel treatments, which are affordable for a greater number of patients. Biosimilars are highly similar but not identical to the reference products; therefore, strict regulatory requirements have been formed for their approval. This ensures that there are no clinically meaningful differences compared with respective biologics, with regard to purity, safety and efficacy. In 2003, a regulatory framework for the approval of biosimilars was established in Europe, whereas the USA did not implement a framework until 2009, when the Biologics Price Competition and Innovation Act was formed. A number of biosimilars have currently been approved in oncology and the number is expected to rise in the near future. More than 10 years of evidence has revealed that biosimilars are safe and effective; however healthcare professionals need to be further educated to eliminate potential misconceptions and integrate biosimilars into routine clinical practice. The present review aims to provide an overview of the biosimilars used in Europe and the USA, present their main benefits and challenges, and discuss their current and future roles in medical oncology.

Biyobenzer İlaçlar

“…Bu süreçteki ortak kriter bir biyobenzerin, biyobenzer olarak kabul edilebilmesi için, herhangi bir hastada referans ürünle aynı klinik sonucu vermesinin beklenmesi ve istenen ek gereksinimleri karşılaması gereksinimidir. 17 EMA, 2015 yılında biyobenzerlerin merkezi bir onay alması gerektiğini ortak karar alarak kabul ederek biyobenzer onaylama ve ruhsatlandırma için FDA ile ortak çalışmalar yürütmüş ve piyasadaki çalışmalar için liderlik etmiştir. 6,15 Bu çalışmalar sonucunda biyobenzerler için üç aşamalı bir geliştirme tasarlanarak karşılaştırmalı yaklaşım adı verilmiştir.…”

“…17,24 Ayrıca Trastuzumab genel kanser kemoterapisi ile birlikte erken HER2 pozitif meme kanseri ve metastatik mide kanseri için de kullanılmaktadır. 17,24,29,30 Trastuzumab referans ürününün patentleri Avrupa Birliği (AB) ve ABD'de (sırasıyla 2014 ve 2019) kısa süre önce sona ermiştir. [31][32][33] Bunla birlikte alternatif olarak firmalar biyobenzer ilaç geliştirme çalışmalarını hızlandırmışlardır.34 Meme kanseri için insan epidermal büyüme faktörü reseptörü 2 (HER2) pozitifliği yüksek dereceli histoloji, lenf nodu tutulumu, daha yüksek hastalık nüksetmesi ve mortalite oranları ile ilişkisi nedeniyle kötü prognoz çerçevesi oluşturmaktadır.3 5 Meme kanserine karşı bir monoklonal antikor olan trastuzumab (Herceptin Roche / Genentech GmbH), bu hastalığın doğal seyrini değiştiren ve HER2 proteinini hedefleyen etkili bir ilaçtır.…”

“…Trastuzumab insan epidermal büyüme faktörü reseptörü 2 (HER2) -pozitif metastatik meme kanseri için bir monoterapi, kemoterapi veya hormon tedavisi ile birlikte kullanılabilir. 17,35 Bunlarla birlikte FDA ve EMA tarıfından onaylanan trastuzumab biyobenzerleri hastalık tedavisini daha erişilebilir bir hale getirmişlerdir. 35 Meme kanseri tedavisi, ek tedavi veya tedaviyle ilişkili yan etkilerin önlenmesinde belirtilen günümüzde kullanılmakta olan EMA ve FDA'den 2018'e kadar onaylı biyobenzerlerleri Tablo 3. de verilmektedir.…”

Changes in the Penetration Rate of Biosimilar Infliximab Within Japan Using a Japanese Claims Database

“…Drug prices of recently approved drugs, including biologics, anti-cancer drugs, and anti-hepatitis C drugs, are especially high. 3 , 4 The Japanese national health-care system is currently facing difficulties due to population aging and the introduction of new high-cost drugs, which may jeopardize its integrity. As such, expanding the usage of biosimilars has been anticipated to be a solution for reducing national health-care costs, given that they are priced approximately 30% cheaper than their reference products within the Japanese national health insurance drug price system.…”

A Randomized, Double‐Blind Study Comparing Pharmacokinetics and Pharmacodynamics of Proposed Biosimilar ABP 798 With Rituximab Reference Product in Subjects With Moderate to Severe Rheumatoid Arthritis

“…This is followed by preclinical assessments, PK and PD evaluations, and finally a confirmatory clinical evaluation of efficacy, safety, and immunogenicity in a representative indication using sensitive population and sensitive end points 10‐12 . Using this regulatory pathway, 2 rituximab biosimilars have been approved in the United States and European Union: Truxima (Celltrion) and Ruxience (Pfizer Inc.) 13‐15 . At the time of this publication, ABP 798 has not been approved by the FDA or other relevant regulatory agency, and the indications are as yet undetermined.…”