The Increasing Role of Biosimilars


Applied Clinical Trials

Biopharmaceuticals are predicted to soon make up 50% of new drug approvals. With the increasing use of biologics in hard to treat disease areas such as rheumatology, oncology, and other chronic diseases, there has been significant interest in the field of biosimilars, known as "biogenerics," "follow-on proteins" or "follow-on biologics."

Biosimilars are new but not identical versions of biopharmaceutical products that have reached patent expiry. This is in contrast to generics, defined by the FDA as drugs that are identical or within an acceptable bioequivalent range to the small molecule innovator drug, with the same dose, strength, safety, efficacy, intended use, and method of administration.

Biologics are more difficult to replicate, as they are developed from larger living organism cells and have higher molecular complexity. As new manufacturers cannot access the cell bank, molecular clone or the exact fermentation and purification process used to develop the original innovator product, biologicals cannot be identically replicated. They must go through clinical trials to eliminate concerns that they might perform differently than the original product.

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