With the patent expiry of the first biotechnologically derived products biosimilars (often also called biogenerics or follow-on proteins) become increasingly popular. The development and approval of biosimilars is however a much more complex task than the development of generics.
The prove of biosimilarity is subject of separate guidance documents and needs tight cooperation between manufacturer and developer/CRO from the early stage of product development to become successful.
Strong scientific background and detailed knowledge of specific issues related to the respective active compound is a must to avoid the pitfalls inherent to biotechnologic products.
CCDRD was involved in the development of the following biosimilar products - parathormone
- insulin
- epoetin
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