Why Comparability Studies are the Key to a Biosimilar’s Success

Comparability Studies are the Key to a Biosimilar’s SuccessBiosimilars, which are new versions of innovator biopharmaceutical products that are marketed after expiration of patents, have emerged as one of the fastest growing development opportunities in the biopharmaceutical sector. In the U.S. alone, industry analysts estimate that biologics worth $80 billion are slated to go off patent by 2015.

Regulatory agencies evaluate biosimilars based on their level of similarity to, rather than the exact replication of, the innovator drug. In the U.S., recent guidance by the FDA says it will “consider the totality of the evidence” when assessing follow-on products. This approach requires sponsors to demonstrate robust chemical comparability to the innovator compound. Continue reading

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