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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Posted 16/10/2009
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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.
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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