Search Results for interchangeable biosimilars

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Interchangeable Biosimilars vs. Biosimilars: Experts Explain Guidance, Discuss Development and Uptake By Zachary Brennan - Published 13 September 2017

Interchangeable biosimilars are headed to the US market over the next several years and discussion of the incoming products kicked off both the Biosimilars Council's conference on Wednesday and RAPS' Regulatory Convergence on Monday.

Categories: News, Europe, US, FDA, Biologics and biotechnology, Drugs

Tags: biosimilars, interchangeable biosimilars

FDA: Interchangeable Biosimilar Approvals Expected Within 2 Years By Zachary Brennan - Published 26 June 2017

The launch of the US biosimilars market has been slow since the pathway for approvals was set up in 2010, with only five US Food and Drug Administration (FDA) biosimilar approvals, none of which have been approved as interchangeable biosimilars.

Categories: News, US, FDA, Biologics and biotechnology, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: biosimilars, interchangeable biosimilars, interchangeability, biosimilar substitution

FDA’s Draft Biosimilar Interchangeability Guidance: Stakeholders Seek More Clarity By Zachary Brennan - Published 04 April 2017

As comments on the US Food and Drug Administration’s (FDA) draft guidance on biosimilar interchangeability begin to trickle in, stakeholders seem optimistic and appreciative of the agency’s draft though some suggest tweaks to FDA's recommendations for switching studies.

Categories: News, US, FDA, Biologics and biotechnology, Due Diligence, Government affairs, Submission and registration

Tags: interchangeable biosimilars, interchangeability, FDA draft guidance, comments on FDA guidance

Are Biosimilars 'Interchangeable' in the EU? A New Perspective By Zachary Brennan - Published 31 March 2017

The EU’s take on the class of medicines known as biosimilars is a slight variation of what is seen in the US, with the US creating two distinct types: Follow-on biologics that are biosimilar, or "expected to produce the same clinical result as the reference product," and ones that are "interchangeable," or able to be switched with their reference product.

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology

Tags: interchangeable biosimilars, interchangeability, switching studies, biosimilar