Biologics

Extracted Attributes

• Sources

  Living organisms including humans, animals, plants, fungi, and microorganisms.

• Composition

  Sugars, proteins, nucleic acids, or complex combinations of these substances; may include living cells or tissues.

• Molecular Size

  Large molecules often exceeding 25,000 atoms (compared to approximately 21 atoms for small molecules like aspirin).

• Primary Applications

  Oncology, rheumatology, cardiology, dermatology, gastroenterology, and neurology.

• FDA Approval Standards

  Must be proven safe, pure, and potent.

• European Regulatory Term

  Advanced Therapy Medicinal Products (ATMPs).

Timeline

• Start of a period (2012-2019) where many patents for blockbuster biologics expired, leading to increased interest in biosimilars. (Source: Wikipedia)

  2012-01-01

• End of the major patent expiration window for several foundational biologic products. (Source: Wikipedia)

  2019-12-31

• FDA Commissioner Marty Makary outlines reforms at the JP Morgan Healthcare Conference to accelerate biologic approvals and biosimilar competition. (Source: Document 065d2e96-4d40-49bd-8511-d8d35f8b01f4)

  2025-01-15

• Publication of industry insights by Johnson & Johnson regarding the mechanism of action and specificity of biologic medications. (Source: Web Search Results (Johnson & Johnson))

  2026-01-09

Biopharmaceutical

A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, whole blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living medicines used in cell therapy. Biopharmaceuticals can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances, or may be living cells or tissues. They (or their precursors or components) are isolated from living sources—human, animal, plant, fungal, or microbial. They can be used in both human and animal medicine. Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general biopharmaceutical category. The term biologics is often used more restrictively to mean biopharmaceuticals that are produced using recombinant DNA technology. Some regulatory agencies use the terms biological medicinal products or therapeutic biological product to refer specifically to engineered macromolecular products like protein- and nucleic acid-based drugs, distinguishing them from products like blood, blood components, or vaccines, which are usually extracted directly from a biological source. Biopharmaceutics is pharmaceutics that works with biopharmaceuticals. Biopharmacology is the branch of pharmacology that studies biopharmaceuticals. Specialty drugs, a recent classification of pharmaceuticals, are high-cost drugs that are often biologics. The European Medicines Agency uses the term advanced therapy medicinal products (ATMPs) for medicines for human use that are "based on genes, cells, or tissue engineering", including gene therapy medicines, somatic-cell therapy medicines, tissue-engineered medicines, and combinations thereof. Within EMA contexts, the term advanced therapies refers specifically to ATMPs, although that term is rather nonspecific outside those contexts. Gene-based and cellular biologics, for example, often are at the forefront of biomedicine and biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available. Building on the market approvals and sales of recombinant virus-based biopharmaceuticals for veterinary and human medicine, the use of engineered plant viruses has been proposed to enhance crop performance and promote sustainable production. In some jurisdictions, biologics are regulated via different pathways from other small molecule drugs and medical devices.

Web Search Results

• Understanding Biologic and Biosimilar Drugs

  ### Making biologics Biologics are made by reproducing, or growing, copies of a specially engineered living cell. This process begins by growing the cells in a carefully controlled facility. In this complex system, the cells develop the proteins that will make up the drug. After this growth of the cells, which can take several weeks and requires constant monitoring, the protein that makes up the drug is extracted and purified until the final biologic drug is obtained. The complexity of biologics can be seen in the final product. While a small molecule drug, such as aspirin, can consist of as few as 21 atoms, biologics can be made of over 25,000 atoms. [...] ### Approving biologics: The FDA review process Like all drugs, biologics are regulated and approved for use by the FDA. Before approval, biologics undergo extensive testing in the laboratory, and are then further tested in clinical trials with patients. The information from these trials is used to establish the safety and efficacy of the biologics. Because of their complex nature and the potential for variability, the FDA pays particular attention to the manufacturing processes involved to ensure that a consistent product can be produced. [...] A biologic is approved by the FDA only after it determines that the manufacturer, also known as the sponsor, has proven that a biologic is “safe, pure, and potent,” and the facilities where the biologic is made conform to good manufacturing practices. “Safety” is determined by comparing the product’s benefits against its risks, “purity” is determined by making sure the product is free from “extraneous matter”, and “potency” is determined by assessing the biologic’s effectiveness in treating the disease in question. ### Biologics and the treatment of cancer

• Biologics (Biologic Medication & Drugs): What It Is & Types

  Biologics are helping people with cancer live longer. Biologics are at the forefront of cancer treatment innovations, including stem cell therapy, gene therapy and immunotherapy. These treatments can complement other cancer treatments to help fight the disease from multiple angles. Biologics like G-CSF can also help you recover from radiation and chemotherapy. [...] Biologics can trigger an immune response. Biologics are more likely to raise a red flag in your immune system than normal drugs. Since biologics resemble living organisms, your immune system might mistake the medicine for an infection. It might activate to remove the medicine or build antibodies against it, making it ineffective. In some cases, biologics might trigger an allergic reaction. Allergies usually target proteins, and many biologics are proteins. [...] Abu Dhabi|Canada|Florida|London|Nevada|Ohio| 855.733.3712|MyChart|Need Help?|Careers|Donate Now| Find a ProviderLocations and DirectionsServicesPatients and VisitorsHealth Library Find a Provider Locations and Directions Services Patients and Visitors Health Library Home/ Health Library/ Medical Treatments/ Biologics (Biologic Medicine) Advertisement Advertisement # Biologics (Biologic Medicine) Biologics are medications that come from living organisms, like proteins and genes. Only living cells reproduce living organisms. Biologic drugs are harder and more expensive to produce than normal drugs. But they may one day treat previously untreatable conditions, including cancers, genetic disorders and autoimmune diseases. Advertisement

• What are biologic medications?

  “Biologics add to our ability to treat human health because they leverage a very natural mechanism that all of us have, which are antibodies,” explains Navin Rao, Ph.D., Global Head of Immunology Discovery at Johnson & Johnson. Antibodies are proteins produced by the immune system that protect the body from pathogens like viruses and bacteria. Biologics harness the power and specificity of antibodies in therapeutic ways to treat disease. “Biologics are manufactured in living cells and purified from there—like little living factories,” Rao says. [...] ## How biologics work—and the diseases they treat Biologics are administered to patients either intravenously or subcutaneously via injection; the mechanism of action depends on the specific drug and the disease target associated with the medical condition. Generally, biologics target specific disease-associated proteins and block signals that cause inflammation and tissue damage. They can also eliminate abnormal cells driving the disease. [...] Written by Erica Sweeney | January 9, 2026 January 9, 2026 Facebook X (Twitter) Pinterest LinkedIn Copy link Biologics are a class of medications made from living cells that are engineered to target specific disease-causing proteins and cells with a high degree of specificity. Some biologics, such as T-cell engagers, can be used to direct the body’s immune system against disease-causing cells. Because biologics are highly specific and highly engineerable, can be designed to work through multiple mechanisms of action and often stay in the body longer, they play an important complementary role alongside another major drug modality: synthetic small-molecule drugs, which are typically taken as oral pills.

• Biopharmaceutical - Wikipedia

  Biologics as a class of medications in this narrower sense have had a profound impact on many medical fields, primarily rheumatology and oncology, but also cardiology, dermatology, gastroenterology, neurology, and others. In most of these disciplines, biologics have added major therapeutic options for treating many diseases, including some for which no effective therapies were available, and others where previously existing therapies were inadequate. However, the advent of biologic therapeutics has also raised complex regulatory issues (see below), and significant pharmacoeconomic concerns because the cost for biologic therapies has been dramatically higher than for conventional (pharmacological) medications. This factor has been particularly relevant since many biological medications are [...] [edit] See also: Biologics for immunosuppression Biologics can refer to a wide range of biological products in medicine. However, in most cases, the term is used more restrictively for a class of therapeutics (either approved or in development) that are produced using biological processes involving recombinant DNA technology. These medications are usually one of three types: [...] With the expiration of many patents for blockbuster biologics between 2012 and 2019, the interest in biosimilar production, i.e., follow-on biologics, has increased. Compared to small molecules that consist of chemically identical active ingredients, biologics are vastly more complex and consist of a multitude of subspecies. Due to their heterogeneity and the high process sensitivity, originators and follow-on biosimilars will exhibit variability in specific variants over time. The safety and clinical performance of both originator and biosimilar biopharmaceuticals must remain equivalent throughout their lifecycle. Process variations are monitored by modern analytical tools (e.g., liquid chromatography, immunoassays, mass spectrometry, etc.) and describe a unique design space for each

• What Are "Biologics" Questions and Answers - FDA

  What is a biological product? Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources - human, animal, or microorganism - and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.