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Home Products How Drugs are Made 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.

Biologics vs. Biosimilars: Key Differences Explained

With the potential to offer targeted therapies and reduced side-effects, the drive towards biologics is exciting. Biologics have revolutionized the prevention, diagnosis, and treatment of cancer, autoimmune conditions, and other diseases. Biosimilars have the potential to enhance treatment...

What Are Biosimilars and How Do They Expand Treatment Options for Patients?

If you’ve experienced sticker shock in the pharmacy and considered not filling a prescription because of the cost, you’re not alone. Recent data shows that almost 13 million Americans delayed filling a prescription or didn’t fill it at all because of the cost.1 In an era of rising drug prices...

How Access to Biosimilar Drugs Could Boost Healthcare Equity

Access. Affordability. Health Equity. These are more than just industry buzzwords; they have real world implications which have a tremendous impact on patients’ lives. For instance, in 2018, racial health disparities were linked to $93 billion in excess medical costs.1 More recently, in 2021 the U...

The medicines available today have taken an average of 12 years to develop. With dedication, creativity, and science, we can significantly cut that time.

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Learn more about the process of joining a clinical trial and find a trial near you.

Go to Pfizer Clinical Trials Site