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8 March 2019

FDA to alter biosimilar ‘suffix’ policy

The US Food and Drug Administration (FDA) 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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Biotechnology
13 December 2018   The US Food and Drug Administration has announced new measures to advance the development of biosimilar medicines.
Americas
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

Biotechnology
13 December 2018   The US Food and Drug Administration has announced new measures to advance the development of biosimilar medicines.
Americas
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

Biotechnology
13 December 2018   The US Food and Drug Administration has announced new measures to advance the development of biosimilar medicines.
Americas
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.