What are Biologics?

Biologics, also known as biological drugs or biopharmaceuticals, are medicines made from living organisms or contain components of living organisms. They are generally large, complex molecules that are manufactured through biological processes using genetically engineered living cells. Common biologics include monoclonal antibodies, vaccines, gene therapy medications, recombinant proteins, and living cells.

How are Biologics Made?

The process of developing a biologic typically begins with isolating the gene that encodes for the desired protein or adding a gene to living cells. These cells, usually mammalian or bacterial, are then grown in bioreactors and induced to produce the therapeutic protein. The cells secrete the protein into the surrounding liquid medium which is then purified through filtration, centrifugation, and chromatography. Additional processes like modification or conjugation may be done to optimize the protein for treating a specific disease. Final drug products are tested extensively for purity, potency, and sterility before approval and release.

Targeting Specific Diseases

Due to their high selectivity and ability to mimic natural processes in the body, many biologics have been developed to target specific diseases. Monoclonal antibodies are a major class of biologics used to treat various cancers, autoimmune disorders, and infections by binding to disease-causing antigens. Vaccines work by exposing the immune system to antigens from pathogens allowing the body to develop targeted defenses against disease. Recombinant proteins like insulin, growth hormone, and clotting factors are replacing earlier crude extracts to treat diabetes, growth disorders, and bleeding disorders respectively. Gene therapies aim to correct genetic mutations by providing a healthy copy of the gene.

Regulatory Approval is Rigorous

Because Biologics are complex and derived from living systems, ensuring their safety, purity, and consistency is challenging. Extensive characterization and comparability testing is required during development and manufacturing changes. Regulatory agencies like the FDA subject biologic license applications to a rigorous approval process involving comprehensive preclinical and clinical testing. Additional oversight is maintained post-approval through lot release testing, pharmacovigilance programs, and periodic facility inspections. The approval path typically takes 10-15 years and costs over $2 billion due to these stringent requirements, making biologics amongst the most highly regulated medicines.

Biosimilars Provide More Treatment Options

Patent expiration of pioneering biologics will drive the future growth of "biosimilar" versions - follow-on biologics that are approved based on demonstrating similarity rather than clinical efficacy trials. Regulatory pathways for approving biosimilars have been established based on totality-of-evidence including analytical, animal, and human pharmacokinetic/pharmacodynamic data compared to the reference product. With lower costs than innovator biologics, biosimilars expand treatment access while continued competition fuels innovation. Areas like interchangeability approvals are still evolving to maximize patient access while ensuring confidence in product substitution.

Manufacturing Complexity Raises Cost Challenges

Producing biologics requires advanced bioprocessing infrastructure and control of living cell-based manufacturing systems presenting unique technical challenges. Scale-up and validation are more complex compared to traditional small molecule drugs. Additional costs arise from supply chain complexities involving multiple component sourcing and strict storage/transport conditions. Manufacturing cell banks and master cell banks is resource-intensive. Quality system demands for biologics manufacturing are unprecedented. Combined with their often targeting of chronic diseases requiring lifelong treatment, these technical and regulatory factors contribute to high costs of biologics making them unaffordable for some patients and healthcare systems. However biomanufacturers are optimizing processes and establishing interchangeable multi-product facilities to enhance efficiencies.

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