Challenges for biosimilar drug development , scale up & higher scale manufacturing : Developed and developing country landscape.

<p>Sumant Chaubey</p>

Challenges for biosimilar drug development , scale up & higher scale manufacturing : Developed and developing country landscape.

Sumant Chaubey

3B Biotech,India

: J Pharm Sci Emerg Drugs

Abstract

The global biosimilars market estimated worth of $2.3 billion in 2015, and is expected to grow at a CAGR of 22.1% by 2020. Various factors contributed for the rise in demand for biopharmaceutical products e.g. drop in healthcare expenditure, growing demand for cost-effective generics, growing occurrence of chronic diseases, and growing aging population. Biosimilars industry is divided into recombinant nonglycosylated proteins, recombinant glycosylated proteins, and recombinant peptides. The recombinant nonglycosylated proteins includes insulin, granulocyte colony-stimulating factor (G-CSF), interferons, and human growth hormones and the recombinant glycosylated proteins includes erythropoietin and monoclonal antibodies. Biologics and biosimilar market is dominated by products from mammalian cell cultures (>75%).There is great opportunities in biopharmaceuticals, novel biologics & biosimilar r-proteins, Vaccines development and process parameter set up.