'Incorrect' To Assume Interchangeables Are Safer, More Effective Than Biosimilars, Says FDA
US FDA India country director Dr Sarah McMullen provides a fact check at a recent conclave to dispel the notion that interchangeable biosimilars are safer and more effective than other approved biosimilars.
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A joint statement from the European Medicines Agency and Heads of Medicines Agencies on biosimilar interchangeability is “concerning,” says Europe’s R&D-based industry federation, EFPIA.
Stakeholders in Europe have been hesitant to allow interchangeable substitution of biological products, prompting the European Medicines Agency to clarify its stance on the issue.
Coherus has revealed further details of the firm’s plans for its Cimerli interchangeable biosimilar rival to Lucentis in the US, including a launch date and pricing information.