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Biological Therapy – Biologics Explained Simply

Biological therapy uses biotechnologically produced agents to precisely target disease processes. It is used in chronic conditions such as rheumatoid arthritis, cancer, and psoriasis.

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Things worth knowing about "Biological Therapy"

Biological therapy uses biotechnologically produced agents to precisely target disease processes. It is used in chronic conditions such as rheumatoid arthritis, cancer, and psoriasis.

What is Biological Therapy?

Biological therapy (also referred to as biologic therapy or biotherapy) is a modern medical treatment approach that uses biotechnologically produced substances known as biologics. Unlike conventional chemically synthesized drugs, biologics are derived from living cells (such as bacteria, yeast, or mammalian cells) and consist of complex molecules including proteins, antibodies, and nucleic acids.

The goal of biological therapy is to intervene precisely in specific disease processes without broadly affecting the entire body. For this reason, it is often described as a targeted therapy.

Areas of Application

Biological therapy is used across a wide range of medical specialties:

Oncology (cancer treatment): Monoclonal antibodies and immunotherapies that directly target tumor cells or activate the immune system against cancer.
Rheumatology: Treatment of rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis using TNF-alpha inhibitors or interleukin blockers.
Dermatology: Management of psoriasis and atopic dermatitis (eczema).
Gastroenterology: Treatment of Crohn's disease and ulcerative colitis with specific antibodies.
Neurology: Use in multiple sclerosis.
Ophthalmology: Treatment of age-related macular degeneration with anti-VEGF agents.

Mechanism of Action

Biologics work by identifying and blocking or activating specific target molecules in the body. Key mechanisms include:

Monoclonal antibodies: Synthetically produced antibodies that bind precisely to specific proteins or cells and neutralize them.
Cytokine inhibitors: Blockers of pro-inflammatory signaling molecules such as TNF-alpha, interleukin-6, or interleukin-17.
Checkpoint inhibitors: Agents that release the brakes on the immune system, enabling it to recognize and attack tumor cells.
Fusion proteins: Molecules that mimic cell-surface receptors and block inflammatory signals.
CAR-T cell therapy: Genetically engineered immune cells from the patient that are designed to target and destroy cancer cells.

Treatment Process and Administration

Biologics are generally not taken orally in tablet form, as they are proteins that would be broken down in the gastrointestinal tract. The most common routes of administration are:

Intravenous infusion: Administered through a vein in a clinic or medical practice.
Subcutaneous injection: Injected under the skin, often as a self-injection that the patient performs at home.

Treatment duration and dosage are determined based on the specific condition and the individual response of the patient.

Side Effects and Risks

Like all medications, biologics can cause side effects. The most common include:

Increased infection risk: Since many biologics modulate the immune system, the body may be less able to fight off infections.
Injection site reactions: Redness, swelling, or pain at the site of injection.
Allergic reactions: In rare cases, severe allergic reactions may occur.
Antibody formation: The body may develop antibodies against the biologic, which can reduce its effectiveness over time.
Reactivation of latent infections: For example, tuberculosis may reactivate, which is why relevant screening tests are performed before starting treatment.

Advantages of Biological Therapy

Compared to conventional treatment approaches, biological therapy offers significant advantages:

Precise mechanism of action with fewer systemic side effects than, for example, corticosteroids or conventional chemotherapy.
Effective for conditions that do not respond adequately to standard therapies.
Improved quality of life for patients with chronic illnesses.
Personalized treatment options supported by biomarker diagnostics.

Biosimilars

As many first-generation biologics have lost their patent protection, so-called biosimilars have become available on the market. Biosimilars are highly similar -- but not identical -- follow-on versions of original biologics. They are assessed by regulatory authorities such as the EMA (European Medicines Agency) for efficacy, safety, and quality before approval.

References

European Medicines Agency (EMA): Biological medicines and biosimilars. ema.europa.eu, 2023.
Smolen J.S. et al.: EULAR recommendations for the management of rheumatoid arthritis. Annals of the Rheumatic Diseases, 2020.
National Cancer Institute (NCI): Biological Therapies for Cancer. cancer.gov, 2022.

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