Drug story: What is Biologics License Application (BLA) accepted by FDA?

Drug story: What is Biologics License Application (BLA) accepted by FDA?

I often see New Drug Applications (NDA) in FDA submissions, so I was curious when I started noticing Biologics License Applications (BLA) in recent filings. For example, the FDA has accepted a BLA for subcutaneous pembrolizumab (Keytruda) for all previously approved solid tumor indications based on positive findings.

Today, I decided to explore the differences between NDA and BLA:

> NDA is used for traditional small-molecule drugs, which are chemically synthesized. eg Aspirin, Paracetamol, Eliquis

> BLA is used for biological products, which are typically derived from living organisms. Examples include vaccines, blood products, gene therapies, and monoclonal antibodies for complex diseases like cancer, autoimmune disorders, and genetic conditions. Their ability to specifically target disease mechanisms makes them highly effective

Advances in biotechnology, such as recombinant DNA technology and mRNA technology, have made it easier to develop and produce biologics. The biologics market is growing faster than the chemical synthesized market.

Next time you come across the term BLA, remember this post!

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