FDA ConneKTion

Timely updates and insights on the latest issues affecting FDA-regulated companies from Kilpatrick Townsend

Archive for February 2016

Posted on Thursday, February 25 2016 at 5:34 pm by -

On the Last Day Sandoz Files Writ of Certiorari Requesting Supreme Court Review

By: Carolina M. Wirth and Jennifer Giordano-Coltart, Ph.D. 

Sandoz Inc. (Sandoz) filed a Petition for Writ of Certiorari (Cert. Petition) on February 16, 2016, requesting U.S. Supreme Court (Supreme Court) review of the U.S. Court of Appeals for the Federal Circuit’s interpretation of the pre-commercialization notice provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

The case relates to Sandoz’s abbreviated biologic license application for Zarxio® (filgrastim-sndz), a biosimilar version of Amgen Inc.’s Neupogen® (filgrastim).  Sandoz provided notice of intent to commercialize its biosimilar to Amgen twice: first upon acceptance of its application by the Food and Drug Administration (FDA) and second, eight months later upon approval of the application.  The notice was given pursuant to § 351(l)(8)(A) of the Public Health Services Act (PHS Act), which states that a biosimilar applicant under subsection (k) of the PHS Act “shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).”


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Posted on Monday, February 15 2016 at 9:20 pm by -

China Aims to Consolidate Drug Market, Support Larger Role for Traditional Chinese Medicines

By: Alyson Wooten, Pharm.D.

The central government of China made a statement on Sunday following a meeting of the State Council outlining plans to consolidate China’s large and fragmented drug market and support a greater role for Traditional Chinese Medicines.

The Chinese government hopes to improve “home-made” medicines in an effort to reduce reliance on drugs from overseas by:

  • providing support for pharmaceutical mergers and acquisitions
  • fostering industry leaders in order to solve the ‘scattered’ nature of the market
  • accelerating the development of China’s domestic drug industry to better serve the people’s healthcare needs, help build a healthier China and “unleash economic growth potential”
  • boosting safety controls and traceability of domestic drugs.


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Posted on , February 15 2016 at 10:29 am by -

Sandoz Ramps Up Biosimilar Program: European Biosimilar Application of Amgen’s Neulasta® Accepted; Acquisition of Pfizer Infliximab Biosimilar

By:  Jennifer Giordano-Coltart, Ph.D.

Neulasta® European Biosimilar Application

Sandoz announced on February 11, 2016 that its Marketing Authorization Application (MAA) for its biosimilar to Amgen’s EU-licensed Neulasta® (pegfilgrastim) was accepted for review by the European Medicines Agency (EMA).1 This follows the Federal Drug Administration (FDA) acceptance of Sandoz’s 351 (k) abbreviated Biologic License Application (aBLA) for pegfilgrastim fled in November, 2015, which used Amgen’s U.S.-approved Neulasta® as the reference product.2
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Posted on Friday, February 5 2016 at 9:56 pm by -

FDA Continues to Grapple with Strategies for Tackling Medical Device Cybersecurity Vulnerabilities

By: Carolina M. Wirth

It is only February, but the Food and Drug Administration (FDA or Agency) has already been actively focusing on issues relating to medical device cybersecurity. Following a public workshop held on January 20-21, 2016, entitled “Moving Forward: Collaborative Approaches to Medical Device Security,”1 the FDA published a new draft guidance for the industry entitled “Postmarket Management of Cybersecurity in Medical Devices 2(Draft Guidance).”3 The Draft Guidance is another step in FDA’s evolving attempt to address growing concerns over cybersecurity threats in medical devices.4 The new Draft Guidance outlines steps that medical device manufacturers should take to continually address cybersecurity risks. The Agency notes that “it is essential that manufacturers also consider improvements during maintenance of devices, as the evolving nature of cyber threats means risks may arise throughout a device’s entire lifecycle,”5 from medical device conception to obsolescence.
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