The Challenge of Manufacturing Biosimilars

For a generic drug manufacturer to win approval of a generic version of a traditional prescription drug, the product must have the same active ingredient, strength, informative article topics controversial debate topicsdosage form and route of administration as the original drug. This means that generic drugs are the exact same chemically as their brand name counterparts and they act the same way in the body.

Such a process is not possible with biologics. Biologics manufacturers must ensure that the manufacturing process remains the same over time by tightly controlling the source and nature of starting materials and consistently employing hundreds of process controls that guarantee predictable results. When a biosimilar is created, it requires a new manufacturing process with new starting minformative article topics controversial debate topicsaterials. As a result, it will produce a product that is different from and not therapeutically equivalent with that of the brand name biologic.

Creating generic versions of traditional prescription drugs is analogous to one chef following another chef’s recipe. If the ingredients and process match, the copy will be identical to the original.

For biologics, however, creating biosimilars would be similar to a chef tasting another chef’s final product and making a dish using different ingredients and a different process to produce a similar result. The second dish might taste similar to the first, but it won’t be identical.

Because of the complex process of manufacturing biologics, the only way to establish whether there are differences that affect the safety and effectiveness of the biosimilars is to conduct clinical trials on each new product. The human body is more sensitive than any laboratory test and that’s why these tests are necessary to determine if biosimilars have any adverse impact in humans.