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    European Regulatory Roundup: Merck Accused of Blocking Remicade Biosimilars (25 May 2017)

    Welcome to our European Regulatory Roundup, a weekly overview of top EU regulatory news. Merck Accused of Blocking Remicade Biosimilars, Using Abusive Discount Scheme The UK’s competition watchdog has accused Merck of running an abusive discount scheme to defend Remicade against biosimilar competition. Merck has a chance to respond to the provisional decision before the watchdog rules whether it has violated competition law and faces a fine. Officials at the Co...
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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 Background In January, FDA released its  draft guidance on biosimilar interchangeability  for consultation, noting that there is "no single data package that will work for all proposed interchangeable products."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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    Congress Calls on HHS to Reverse Biosimilar Reimbursement Policy

    Sen. Pat Roberts (R-KS), and Reps. Joe Barton (R-TX) and Anna Eshoo (D-CA) as well as 52 other representatives and nine senators sent letters to Tom Price, Health & Human Services secretary, and Seema Verma, administrator for the Centers for Medicare & Medicaid Services (CMS) with concerns about the biosimilar reimbursement policy from a recently issued final rule. The final rule, issued by CMS on 30 October 2015, stipulates that each biosimilar of the same refere...
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    FDA Approves 5th Biosimilar, 2nd for Remicade

    The US Food and Drug Administration (FDA) on Friday announced its fifth biosimilar approval: Samsung Bioepis’ Renflexis (infliximab-abda), an intravenous infusion for multiple indications. This is the second FDA approval for a biosimilar to Johnson & Johnson’s Remicade (the first was Pfizer and Celltrion’s Inflectra (infliximab-dyyb)), though both Inflectra and Renflexis have been approved as biosimilars but not as interchangeable biosimilars. The shift in the...
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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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    House Bill Seeks to Expand Off-Label ‘Scientific Exchange’ Between Industry, Doctors

    While the US Food and Drug Administration (FDA) attempts to re-work its policy on off-label use communications, Rep. Morgan Griffith (R-VA) has introduced a new bill that would further allow pharmaceutical companies to discuss such uses with physicians. GOP representatives have criticized FDA recently for failing to update its policies on off-label use communications as the agency has lost several recent court cases on the issue , and has questioned the need for loos...
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    Updated: Duplicate MAAs: Amgen Wins EU-wide Approval for Two Humira Biosimilars

    The European Commission (EC) on Thursday granted two marketing authorizations for Amgen’s biosimilars for Humira (adalimumab), known as Amgevita (adalimumab) and Solymbic (adalimumab). Amgevita is authorized for all of the same indications as Humira, while Solymbic, which won approval through a duplicate marketing authorization application (MAA), is authorized for all indications except polyarticular juvenile idiopathic arthritis. Duplicate MAAs: Public Health or Co-Mar...
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    FDA Considers Creating New 'Office of Patient Affairs'

    As part of efforts to better capture patients' perspectives, the US Food and Drug Administration (FDA) on Monday said it is considering establishing an "Office of Patient Affairs," to be tasked with supporting and coordinating patient engagement across the agency. The move to create the office would be part of the agency’s efforts to offer “a single, central entry point to the Agency for the patient community,” as well as “triage and navigation services for inbound inqu...
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    EU Industry Groups Urge Caution on Biosimilar Switching

    Three EU biopharmaceutical industry groups are offering key considerations to physicians when switching from a biologic reference product to its biosimilar or from one biosimilar of a reference product to another, according to a new position paper released on Thursday. While noting a lack of regulatory requirements for individually approved biosimilars to the same reference product to be compared with each other, the trio note: “Switching between biosimilars represents ...
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    EMA Explains How it Supports Article 58 Applications

    The European Medicines Agency (EMA) on Tuesday released a document discussing the regulatory support available to drugmakers looking to submit applications via the Article 58 procedure in an attempt to increase access to medicines in low- and middle-income countries (LMICs). Background First introduced in Regulation (EC) No. 726/2004 in 2004, the Article 58 procedure allows EMA's Committee for Medicinal Products for Human Use (CHMP) to give opinions, in collaboration ...
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    European Commission Offers New Q&A on Biosimilars

    The European Commission on Monday unveiled a new question and answer document for those looking to better understand biosimilars. Similar to the Focus  explainer on biosimilars , the 9-page EC explainer, available in seven languages, offers a quick 10,000-foot view of the biosimilars landscape, answering questions that patients might have on what a biologic is, what a biosimilar is, how biosimilars compare to generics, what types of studies biosimilars must undergo pri...
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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...