The potential market for complex generics is substantial, but navigating the FDA’s guidance for proving “sameness” is a real minefield...
Bérangère Tissot |
Generic medicines are now an established part of the pharmaceutical supply chain and offer significant savings to health services, insurers and patients alike. More recently, biosimilars have entered the fray, and while the savings are not as great as with small molecule generics, they still help cut the costs of medicine. However, there is also a third category of product that falls between the two – the complex generic. These are products that may include complex: active ingredients, formulation, route of delivery, or even a mixture of ingredients.
The key to creating a new generic or biosimilar medicine and gaining regulatory approval is proving that it is safe and comparable to the originator product. For a small molecule generic, proving “sameness” between the two is relatively straightforward, relying heavily on a sub-set of well-defined analytical methods. Biologics are very different because the exact nature of the product depends on how it is manufactured, leading regulators to demand clinical studies that prove the biosimilar is functionally comparable to the reference product.
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