17 July 2020 - Investigators found that process complexities have created numerous difficulties for biosimilar developers in regulatory filings, but they anticipate that the success rate will improve with experience and improved guidance.

Developing biosimilars is not an easy process. Exact details of the manufacturing process are typically not available from the reference manufacturer. Further, minute variations in product quality can be magnified as biosimilar production moves through its various stages. 

For these reasons, biosimilar developers often run into complications when seeking approval from regulatory authorities.

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