MBBP Client MindChild Medical, Inc. Receives FDA Clearance of Fetal Heart Monitor

MindChild Medical, Inc., a client of MBBP, has received FDA clearance for its Pre-Marketing Notification (510(k)) for its MERIDIAN™ M110 non-invasive fetal heart monitor. The FDA clearance will enable MindChild to enter the U.S. market with MERIDIAN™. MindChild's MERIDIAN™ M110 Fetal Monitoring System is an intrapartum fetal monitor that externally measures and displays fetal heart …

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Apotex’s Second Biosimilar Application Accepted by FDA

By: David A. Fazzolare and Joanna T. Brougher On February 18, 2015, Apotex Inc., announced that the Food and Drug Administration (FDA) had accepted its application for a biosimilar version of Amgen Inc’s Neupogen®. Apotex is second to Sandoz Inc. to propose a biosimilar version of Neupogen® (filgrastim), which is administered during chemotherapy to boost …

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FDA Recommends Approval of Sandoz’s Biosimilar Drug, a First

By: David Fazzolare On January 5, 2015, the US Food and Drug Administration’s (“FDA’s”) Oncologic Drugs Advisory Committee (the “Committee”) announced its recommendation that the FDA approve Sandoz Inc.’s application to market Zarxio® (EP2006), a biosimilar version of Amgen, Inc.’s Neupogen® drug.  The Committee explained its recommendation in a 62-page, publicly-issued briefing document.  Zarxio® is the …

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Federal Circuit in Sandoz v. Amgen Upholds District Court Ruling on Standing Requirements in Biosimilars Cases

By: David A. Fazzolare The recent back and forth between Amgen and Sandoz took another dramatic turn on December 5, 2014, when the Federal Circuit affirmed the district court’s dismissal of Sandoz’s declaratory judgment lawsuit against Amgen because Sandoz’s alleged injury did “not meet the requirements of immediacy and reality” necessary for standing. Regarding immediacy, …

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FDA Establishes “Purple Book” for Biosimilars

By: David Fazzolare and Joanna Brougher On September 9, 2014, the FDA announced the establishment of the “Purple Book” (formally entitled “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations”), which is the equivalent for biologics of the FDA’s “Orange Book.” Whereas the Orange Book lists all small molecule reference …

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Second Biosimilar Application Filed Under BPCI Act by Celltrion

By: David Fazzolare and Joanna Brougher On August 8, 2011, Celltrion announced that it filed a biosimilar application under the Biologics Price Competition and Innovation Act (BPCI Act) for its infliximab biosimilar.  Celltrion's infliximab biosimlar is already marked in over 50 countries worldwide, including Europe, Canada and Japan, under the brand name of Remsima®.  Celltrion's announcement comes …

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David Fazzolare Quoted in FDA Week Biosimilar Article

On August 8th InsiderHealthPolicy.com’s FDA Week, an exclusive weekly report on Food and Drug Administration Policy, regulation and enforcement, published an article titled “Biosimilar ‘Patent Dance,’ Litigation Could Coincide With Possible Approval”. The article discusses the FDA’s recent acceptance of the first biosimilar application from Sandoz for a biosimilar filgrastim, a version of Amgen’s Neupogen. This …

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FDA Releases Guidance for Determining Biologic Exclusivity Under the BPCI Act

By: David Fazzolare & Joanna Brougher On August 4, 2014, the Food & Drug Administration (FDA) released its latest guidance in a series of guidance documents issued as part of its ongoing effort toward implementing a biosimilar approval pathway under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).  In contrast to previously …

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Biosimilars Developers Watch Closely as FDA Accepts First Biosimilar Application from Sandoz

By: David Fazzolare & Joanna Brougher Sandoz, a Novartis Group company, announced on July 24, 2014 that the US Food and Drug Administration (FDA) has accepted for review its application for a biosimilar version of filgrastim. The reference product, Neupogen®, which brought maker Amgen Inc. $1.4 billion in sales in 2013, is a biologic used …

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Massachusetts Enacts Biosimilar Substitution Law

By: Stanley Chalvire Massachusetts recently enacted Chapter 143 of the Acts of 2014, entitled “An Act relative to the substitution of interchangeable biosimilars,” authorizing pharmacists to fill prescriptions that are written for brand name biological products with the corresponding and generally less expensive biosimilar product.  A biosimilar is a biological medicine that the U.S. Food and …

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