Current perspectives on biosimilars

Abstract

In this work, an overview of the biosimilars market, pipeline and industry targets is discussed. Biosimilars typically have a shorter timeline for approval (8 years) compared to 12 years for innovator drugs and the development cost can be 10–20% of the innovator drug. The biosimilar pipeline is reviewed as well as the quality management system (QMS) that is needed to generate traceable, trackable data sets. One difference between developing a biosimilar compared to an originator is that a broader analytical foundation is required for biosimilars and advances made in developing analytical similarity to characterize these products are discussed. An example is presented on the decisions and considerations explored in the development of a biosimilar and includes identification of the best process parameters and methods based on cost, time, and titer. Finally factors to consider in the manufacture of a biosimilar and approaches used to achieve the target-directed development of a biosimilar are discussed.

Recent Developments in Bioprocessing of Recombinant Proteins: Expression Hosts and Process Development

“…In a fed-batch process, nutrients are fed during cultivation. In perfusion culture, the medium is circulated through a growing culture to allow simultaneous waste removal and nutrient supply (Agbogbo et al, 2019). In a continuous or chemostat bioreactor culture, feed containing essential nutrients is fed in and product containing culture is recovered continuously.…”

From Biologics to Biosimilars and Biobetters – Democratization of High-end Therapeutics

“…[ 1 2 3 ] Biosimilars are made frugally in half the time and at about a tenth of the cost of the innovator biologic. [ 6 ] Approval is based on demonstration of analytical proof of biosimilarity, an animal study on toxicity, and a brief clinical study, and not on independently establishing the safety and efficacy of the proposed product [ Fig. 1 ].…”

Biyobenzer İlaçlar

“…2,6 Biyobenzerler, lisanslı biyolojik ilaçları referans alan, resmi olarak FDA [U.S. Food and Drug Administration: Amerikan Gıda ve İlaç Dairesi], EMA [European Medicines Agency: Avrupa İlaç Ajansı] tarafından onaylanan versiyonlarıdır. 1,7,8 Biyobenzerlerin referans aldığı biyolojik için yapılan tüm araştırmalar yapılarak kalite, güvenlik ve etkinlik bakımından benzerliği kanıtlamalıdır. Biyobenzerler referans ürünleriyle aynı amino asit sekanslarına sahip olsalar da 3 boyutlu yapı, glikosilasyon bölgeleri, izoform profilleri ve protein agregasyonu bakımından farklılık gösterirler.…”

“…Güvenlik, etkililik ve immünojenik değerlendirmeye yönelik klinik çalışmaların referans biyolojik ile karşılaştırılmasını içermelidir. 7,18,22 Tablo 3. Avrupa İlaç Ajansı (EMA) ve ABD Gıda ve İlaç Dairesi (FDA) tarafından onaylanan ve meme kanseri tedavisinde kullanılabilecek biyobenzerler (Ağustos 2018).…”