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    FDA approves Semglee as first biosimilar interchangeable insulin

    The US Food and Drug Administration (FDA) has approved the first interchangeable biosimilar product, giving the designation to a once-daily insulin product to treat diabetes.   FDA’s designation of Semglee (insulin glargine-yfgn, Mylan) as interchangeable with Lantus (insulin glargine, Sanofi) means that Semglee may now be substituted for the reference product at the pharmacy “without the intervention of the prescriber,” noted FDA in a Wednesday evening press release ...
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    Interchangeable Biosimilars vs. Biosimilars: Experts Explain Guidance, Discuss Development and Uptake

    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. Leah Christl, associate director for therapeutic biologics at the US Food and Drug Administration (FDA), on Monday presented on a recently released FDA draft guidance for industry on interchangeability , outlining the studies necessar...
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    FDA: Interchangeable Biosimilar Approvals Expected Within 2 Years

    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. And though FDA cannot disclose what applications have been submitted to the agency due to confidentiality issues, FDA’s biosimilars lead Leah Christl said last week at DIA’s annual conference in Chicago that she expect...
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    FDA’s Draft Biosimilar Interchangeability Guidance: Stakeholders Seek More Clarity

    As comments on the US Food and Drug Administration’s (FDA) draft guidance on biosimilar interchangeability begin to trickle in, stakeholders seem optimistic and appreciative of the agency’s draft though some suggest tweaks to FDA's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. Background In January, FDA released its draft guidance on biosimilar interchangeability for consultation, noting that there is "no single data package that will work for all proposed interchangeable pr...
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    Are Biosimilars 'Interchangeable' in the EU? A New Perspective

    The EU’s take on the class of medicines known as biosimilars is a slight variation of what is seen in the US, where there are 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. Arguments over interchangeability in the US (from whether pharmacists should be allowed to switch a biologic for its...
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    Zarxio, First Biosimilar Approved in the US, Added to FDA's New 'Purple Book'

    Slowly but surely, the US Food and Drug Administration (FDA) is making quiet but substantial updates to its new "Purple Book"— a list meant to describe the degree to which a biosimilar drug is equivalent to the biologic product it references. Background FDA first launched its Purple Book in September 2014 in anticipation of the impending approval of several new "biosimilar" products. The first of those biosimilars, Zarxio (filgrastim-sndz), was approved on 6 March 2015....