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Singapore outlines process to register biosimilars Posted 16/10/2009

Drugmakers seeking to register a biosimilar product in Singapore should provide complete information on the development, control and manufacture of the drug and its active ingredient, a new guidance says. Comparability studies between the biosimilar product and its reference product also must be submitted, the Health Sciences Authority says in the guidance posted on its website on 1 August 2009.

The guidance document describes the basic principles of a similar biological product, as well as the procedures and requirements for registration of a similar biological product.

The document is intended to:

  • introduce the concept of similar biological products
  • outline the basic principles to be applied for similar biological products
  • describe the procedure and documentary requirements for submitting an application for a similar biological product
  • describe the pharmacovigilance requirements for similar biological products
  • describe the post-approval batch release requirements for similar biological products

The guidance document is adapted mainly from the EMEA guidelines on similar biological products, with consideration of Singapore’s local regulatory environment.

References:
FDAnews Drug Daily Bulletin Vol. 6 No. 188, 28 September 2009. Singapore outlines process to register biosimilars.

Guidance on registration of similar biological products in Singapore, August 2009.

Source: FDAnews Drug Daily Bulletin

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