Month: April 2025

Biosimilars have emerged as a promising solution to escalating prescription drug costs, offering potential cost savings and increased affordability for patients. As the market for these innovative medicines continues to…

Extrachromosomal DNAs (ecDNAs) are circular DNA structures located in the nuclei of cells outside chromosomes. They were originally discovered in chromosome spreads of cells obtained from embryonal tumors in the…

In the European Union (EU), a legal framework for approving biosimilars was established in 2003. This framework means that biosimilars can only be approved centrally via the European Medicines Agency…

The European Commission (EC) granted marketing authorization for eight biosimilars: Biocon’s Yesintek,Celltrion’s Avtozma, Eydenzelt, Osenvelt and Stoboclo; Samsung Bioepis’ Obodence and Xbryk, and CuraTeQ Biologics’ Zefylti in February 2025. The eight biosimilars approved by the EC include one aflibercept, four denosumab, one…

Choosing the right Bio-Kill Tank system is a critical decision. Deciding between a full and semi-automatic system can be challenging. Here’s a blog where we shed light  the advantages and…

The ustekinumab market is heating up as biosimilar developers aggressively challenge the dominance of Stelara, Johnson & Johnson’s blockbuster drug for autoimmune diseases. With eight biosimilars approved in Europe and seven in the…

After analytical characterization and non-clinical studies, originator approval relies on proof of clinical benefit vs. standard care. For biosimilars, the development phases’ importance is opposite to the originator’s: analytical assessment…

On 27 March 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions, recommending the granting of a marketing authorization for three biosimilar…

Introduction Bioreactors are pivotal instruments in modern biotechnology, serving as controlled environments for biological reactions. They enable the cultivation of cells, tissue or microorganisms under precisely regulated conditions, facilitating the…