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.
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Biosimilars
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- Canada approves pegfilgrastim biosimilar Armlupeg
- FDA approves fifth ustekinumab biosimilar Imuldosa
Research
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- Long-term real-world safety experience of biosimilars confirms concept of biosimilarity
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General
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- Biosimilar medicines on the Pharmaceutical Benefits Scheme in Australia
- SBR issues consensus on interchangeability of reference products and biosimilars
- Innovative direct purchase agreement sees adalimumab biosimilar prices slashed
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