Safety Issues of Biosimilar Products

What is it about?

Difference between generic biotech and biosimilar products are: a) Biologic medicines are not made using a set of standard materials, but are developed using unique biological systems and living cells. As a result, the active ingredient is impossible to recreate exactly and the selected cell lines from which the biologic medicine originates are unique to each manufacturer b) The manufacturing process for biologic medicines is generally more complex than manufacturing processes for chemical drugs. Unlike small molecule drugs, biologic medicines are produced in genetically-engineered living cells that are sustained in a highly-controlled environment. The protein produced by the cells will be influenced by individual cell characteristics as well as the environment and nutrients provided c) Each manufacturer has different processes that create distinctive characteristics in the product, which are specific to the manufacturer. This creates a unique relationship between a biologic’s manufacturing process and the final product approved by regulators.

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Photo by Raka Rachgo on Unsplash

Photo by Raka Rachgo on Unsplash