A Complete Guide to Regulatory Pathways for Biosimilars in the EU and US

 

Biosimilars are biologic products highly similar to an already approved reference product, with no clinically meaningful differences in safety, purity, or potency. Unlike generic drugs, biosimilars involve intricate manufacturing processes due to the complexity of their molecular structures and the living systems used in their production.

Given their potential to reduce healthcare costs and increase patient access, regulatory authorities in the EU and US have established specific pathways to ensure the safety, efficacy, and quality of these products.

Read more about different pathways here: https://resource.ddregpharma.com/blogs/a-complete-guide-to-regulatory-pathways-for-biosimilars-in-the-eu-and-us/

Contact us today to fastrack your product in the market: https://resource.ddregpharma.com/blogs/a-complete-guide-to-regulatory-pathways-for-biosimilars-in-the-eu-and-us/

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