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.
Singapore outlines process to register biosimilars
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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.
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