The Differences Between Generic and Biosimilar Drugs
Consider the differences between generic drugs and biosimilar drugs and you’ll notice quite a few differences as far as treatment options, drug structure, and consistency. Firstly, generics (or small-molecule drugs) offer consistency as far as the way they’re structured and synthesized, using a copycat chemical process to ensure treatment, dosage, and side effects are relatively the same each and every use. Biosimilar (or biologic) drugs don’t offer the same consistency as they’re created using living cells, usually bacteria or yeasts taken from plant, animal, or living human cells. However, the inconsistent nature of biologics make them suitable to treat a wider variety of diseases.
Here are the major differences between biosimilar drugs and generic drugs:
- Biosimilar are biologically-derived from complex, living structures (i.e., living plant or animal systems like yeasts or bacteria). This makes them large and dense in size compared to small-molecule generic drugs, derived from a consistent chemical process.
- When it comes to legalities, you can expect an almost exact copy with a generic drug. Maybe the drug was manufactured by another pharmaceutical company but the U.S. Federal Drug Administration (FDA) demands the drug’s chemical structure is almost identical. To compare, biosimilar drugs are regulated by the FDA more closely due to their unreliable nature.
- The FDA categories biological drugs under the following categories—vaccines, tissues, gene therapies, allergenics, somatic cells, recombinant therapeutic proteins, and blood and blood components, based on the substances (i.e., sugars, proteins, living cells and tissues) they’re extracted from. To compare, generic drugs are chemically-developed using tiny, homogeneous molecules, so they’re considered bio equivalent copies of the original drug.
- Because generic drugs are identical by nature to their brand drug, they offer consistency as far as what diseases they treat, dosage strength, safety and side effects, and storage. However, while the living nature of biologic drugs opens them up to treat a wide range of medical conditions where few alternative options exist, they’re considered inconsistent as far as intended use, storage (i.e., refrigeration), dosage, side effects, and effectiveness.