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    FDA offers new Q&A on biosimilars and interchangeable products

    In a draft questions and answers guidance issued Thursday, the US Food and Drug Administration (FDA) offers insights into how it will handle certain aspects of submissions and labeling for interchangeable biosimilars.   When finalized, FDA will move the questions and answers from the draft guidance to its companion final questions and answers guidance on biosimilar development.   In the first of four questions and answers in the draft guidance, FDA explains how i...
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    Where are the Interchangeable Biosimilars?

    In June 2017, Leah Christl, former biosimilar lead at FDA, told a conference in Chicago that interchangeable biosimilars were likely coming to the US market within two years . And although no interchangeable biosimilar has been approved by FDA yet, and Christl has since moved on to Amgen , progress on interchangeable biosimilars has been made, albeit slowly, in the intervening years. Most recently, Boehringer Ingelheim announced that it has completed , as of last ...
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    Industry Groups Call on FDA to Dispel Biosimilar Misinformation

    The Association for Accessible Medicines (AAM) and its Biosimilars Council, as well as the pharmacy benefit manager association, the Pharmaceutical Care Management Association (PCMA), are backing a Pfizer petition that calls on the US Food and Drug Administration (FDA) to do more to counteract untruthful or misleading information on biosimilars. The AAM comment, related to Pfizer’s petition , specifically targets the term “non-medical switching” and the concept of inte...
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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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    Biopharma Companies Take Issue With FDA's Draft Biosimilar Interchangeability Guidance

    Ahead of Friday's deadline for comments, a number of biopharmaceutical companies are seeking further clarification from the US Food and Drug Administration (FDA) on various aspects of the draft biosimilar interchangeability guidance. 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 products." The draft calls on co...
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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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    FDA Issues Long-Awaited Biosimilar Interchangeability Guidance

    The US Food and Drug Administration (FDA) on Tuesday released for public consultation its long-awaited draft guidance detailing the agency's expectations for demonstrating biosimilar interchangeability. The guidance, which was initially expected to be published before the end of 2015, recommends that sponsors looking to get a biosimilar approved as interchangeable with its reference product conduct one or more switching studies to show that patients can alternate between...
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    CDER Guidance in 2017: Lots of Procedural and Quality Documents Coming

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Wednesday released its agenda of new and revised draft guidance documents to be published this calendar year, and it includes several eagerly-awaited documents, such as ones on biosimilar interchangeability (which has been on the list since 2015) and a revision of a draft on postmarket safety reporting for drugs and biologics. The 102 draft guidance documents slated for release ...
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    FDA May Push Back Release of Biosimilar Interchangeability Draft Guidance

    Although the Food and Drug Administration (FDA) has continued to say publicly that draft guidance on how an interchangeable biosimilar will be defined should come out by the end of 2016, the user fee reauthorization commitment letter released this week says the draft will publish sometime before 31 December 2017. The letter, which contains the performance goals and procedures for the Biosimilar Biological Product User Fee Act (BsUFA) reauthorization for fiscal years 2...
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    Biosimilar Interchangeability: ‘Careful What You Wish For’

    As the open question around interchangeable biosimilars in the US continues to drive the discussion on what the US Food and Drug Administration (FDA) will require for such a designation, some experts are saying the designation might not actually be that important for the biosimilar market as a whole. Ronny Gal, senior analyst in specialty pharmaceuticals equity research at Sanford Bernstein, told attendees at GPhA’s first biosimilars conference on Thursday that although...
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    Drugmakers Split on Whether to Include Interchangeability Statement in Biosimilar Labels

    Drug, biologic and biosimilar companies’ comments on US Food and Drug Administration (FDA) draft guidance on biosimilar labeling reveals a major split between those who do and do not want a statement on a biosimilar’s interchangeability status on each new product's label. The comments come as FDA has still yet to release its guidance on what interchangeability means, and as FDA has not found any biosimilar to be interchangeable with its reference product. However, th...