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Designation of Interchangeability (IC) for Biosimilars in the US: To Be IC or Not IC? That Is the Question

The "interchangeable" designation has created confusion around the difference between biosimilars designated as interchangeable and those that are not. ....

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Interchangeability of biosimilars in the EU – the industry impact

EU medicines regulators have for the first time published a statement supporting the interchangeability of biosimilar medicines in the EU. ....

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European Regulatory Heads Make Biosimilars Interchangeable | Goodwin

On September 19, 2022, the European Medicines Agency’s (“EMA”) Biosimilar Medicines Working Party (“BMWP”) and the Heads of Medicines Agencies (“HMA”), a network of the heads of. ....

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