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13 December 2018Biotechnology

FDA releases plan to boost biosimilars development

The US Food and Drug Administration (FDA) has announced new measures to advance the development of biosimilar medicines.

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More on this story

Americas
FDA announces new measures to boost gene therapy innovation
16 January 2019   The US Food and Drug Administration has announced new policies to advance the development of safe and effective cell and gene therapies.
article
FDA to alter biosimilar ‘suffix’ policy
8 March 2019   The US Food and Drug Administration yesterday announced draft revisions to its policy on the naming of biosimilars, in an attempt to appease critics who say that renaming previously-licensed products is too expensive.
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Diabetics to benefit under latest FDA biosimilar guidance
13 May 2019   The Food and Drug Administration has issued final guidance on the pathway for ‘interchangeable’ biosimilar products, in a bid to promote competition in the biologics market.

More on this story

Americas
FDA announces new measures to boost gene therapy innovation
16 January 2019   The US Food and Drug Administration has announced new policies to advance the development of safe and effective cell and gene therapies.
article
FDA to alter biosimilar ‘suffix’ policy
8 March 2019   The US Food and Drug Administration yesterday announced draft revisions to its policy on the naming of biosimilars, in an attempt to appease critics who say that renaming previously-licensed products is too expensive.
Americas
Diabetics to benefit under latest FDA biosimilar guidance
13 May 2019   The Food and Drug Administration has issued final guidance on the pathway for ‘interchangeable’ biosimilar products, in a bid to promote competition in the biologics market.

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