Meeting the Requirements for Biosimilars

The European Medicines Agency has launched a public consultation on a revision of the guideline addressing similar biological products (biosimilars) containing biotechnology-derived proteins as the active substance.

The document lays down the non-clinical and clinical requirements for marketing authorisation of a biosimilar claiming to be similar to a biological product already marketed.

Biosimilars have been the focus of huge discussion within the EMA recently. Public consultation on revisions to the guideline on similar biological medicinal products, and on the guideline addressing the quality issues related to biosimilar development have also been initiated in the past 13 months.

"Ensuring the identity, purity, safety and quality of a biopharmaceutical is critical to its success," notes Andrew Kenyon, biopharmaceutical analysis specialist at RSSL. "All of the existing and proposed changes to current guidelines should help developers and manufacturers gain a clearer understanding of what is expected of them, and we can support customers through the development, production and quality assurance cycle with analysis, training and consultancy."

RSSL's analytical services include host cell DNA and protein contamination detection, protein and impurity profiling, glycosylation profiling, and stability storage to ICH guidelines. GMP, GDP and GCP are just some of the specialist courses provided by RSSL's Training department, along with a specific course covering biotechnology issues (scheduled next for July 18th).

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