Why Are Biologics Important?
While most drugs have a known structure and so can be chemically synthesized, biologics are derived from existing natural systems. This gives them a larger, more complex structure.
As a result, the treatments derived from them are more challenging to produce.
But the effort has paid off.
Biologics are helping to advance patient care by delivering highly effective and targeted treatment across multiple life-threatening and chronic diseases—for conditions where patients have had few effective options.
Approved by the FDA, biologics are now used in the fields of oncology, inflammation and immunology, rheumatology, gastroenterology, diabetes, neurology, and inherited conditions.
What Is a Biosimilar?
Biosimilars are medicines specifically designed to have similar properties to a drug that’s already been created and licensed.
Since biosimilars are never exact copies of the medicine they’re designed to imitate, their safety and effectiveness must be independently established.
Regulatory guidance for biosimilars has been developed in Europe, the United States, and many countries throughout the world. To meet these standards scientists gather widespread evidence, work together with limited nonclinical studies, and collect detailed comparative human pharmacokinetics and efficacy in a relevant patient population.
This “totality of evidence” helps ensure that patients receive quality products that are both safe and effective.