Biologics, A History Of Agents Made From Living... Info

The advent of genetic engineering transformed biologics from natural extracts into "designer" therapies.

The foundation of biologics began with early immunology and the use of natural substances to prevent or treat infectious diseases. Biologics, A History of Agents Made From Living...

: Louis Pasteur developed a method of active immunization against rabies, which was first successfully tested on a child in 1885. The advent of genetic engineering transformed biologics from

Early production lacked oversight, leading to tragedies that spurred federal regulation of biological products. Early production lacked oversight, leading to tragedies that

: In response to these deaths and others caused by contaminated smallpox vaccines, Congress passed the Biologics Control Act . This was the first federal law to regulate the safety and purity of biological products, requiring annual licensing and facility inspections. The Mid-20th Century Expansion (1920s – 1960s)

: The first monoclonal antibody therapy, Muromonab-CD3, was approved, introducing a new level of precision by targeting specific proteins in the immune system.

: With the expiration of patents for original biologic drugs, "biosimilars"—highly similar but not identical copies—have entered the market to increase patient access and reduce costs.