Biosimilars Development Demands Expertise Across All Phases of Development

Biosimilars Development Demands Expertise This is an exciting time for biosimilars. Based on a recent MarketsandMarkets report, the global biosimilars market is expected to be worth $19.4 billion by 2014, growing at a CAGR of 89.1% from 2009 to 2014.

While the opportunity is immense, the risk involved with biosimilar development is still high with large up-front investment required and possible failure of the drug during development stages. Given the nature of biosimilars development, choosing the right CRO with capabilities across the drug development spectrum is critical to market success. Continue reading

Biotherapeutics and Immunogenicity Implications in Drug Development

Immunogenicity

In contrast to new chemical entities, biotherapeutic drugs are potentially immunogenic, and, in rare cases, treatment with such products can lead to severe and devastating illnesses in humans. Therefore, the importance in understanding how immunogenicity affects drug exposure, efficacy, and toxicity at all stages of the drug development process can not be overstated.

There are more than 200 biotechnology products currently on the market with 400-plus additional therapies in clinical trials targeting diseases such as cancer, Alzheimer’s, rheumatoid arthritis, multiple sclerosis, and HIV/AIDS. In 2014, it’s predicted that 50% of the top 100 drug sales will be biologics, an increase of 28% from 2008. Continue reading