A biologic is a medicinally large molecular product that is created from a living organism and contains proteins from living cells. In other words, it’s a product created from a living thing, on a molecular level. Because biologics are much larger and more complex than typical small-molecule drugs, the manufacturing processes are very complicated. In the United States, biologics are approved by the Food and Drug Administration (FDA), under a process distinct from new small-molecule drug approvals, or approvals for traditional medicines.

Biologics & Biosimilars

Q: Why Are Biologics Important?

Biologics have helped advance patient care by delivering highly effective and targeted treatment across multiple life-threatening and chronic diseases in the fields of oncology, inflammation/immunology, rheumatology, gastroenterology, diabetes, neurology, and inherited conditions.

Q: What Is a Biosimilar?

Biosimilars, on the other hand, are drugs specifically designed to have similar properties to a drug that’s already been created and licensed. But because biosimilars are never exact copies of the medicine they are designed to imitate, establishing appropriate standards for biosimilarity remains an important area for scientific, legislative, and regulatory debate. Regulatory guidance for biosimilars has been developed in Europe, the United States, and many countries throughout the world.

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Biologics & Biosimilars

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.

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