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With More Biosimilars Approved, FDA Urged to Track Adverse Events

Noting the complexities of biological products and the potential differences in products created from different living cells, Dr Miletich emphasised that biotechnology is an evolving field. "While much more is known today than 30 years ago, FDA's guidance documents should candidly acknowledge that there are some things we still do not scientifically know today," he told the hearing.

As the FDA finalises its guidances for the development of biosimilars, it must adopt policies to facilitate attribution of adverse events and foster manufacturer accountability, he added. The arrival of biosimilars in the US marketplace will significantly increase the challenge and importance of accurate tracking and tracing, and the use of distinguishable established names will facilitate prompt identification and resolution of product problems, he suggested.

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