Regulatory Focus™ > News Articles > Regulatory Recon: First US Biosimilar Launched at 15 Percent Discount (3 September 2015)

Regulatory Recon: First US Biosimilar Launched at 15 Percent Discount (3 September 2015)

Posted 03 September 2015 | By Michael Mezher 

Regulatory Recon: First US Biosimilar Launched at 15 Percent Discount (3 September 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

In Focus: US

  • Novartis Launches First US 'Biosimilar' at 15 Percent Discount (Reuters)
  • Amgen Retracts Diabetes-Obesity Paper Due to Data Manipulation (In-Pharma Technologist) (BioSpace)
  • FDA Warns of Potentially Fatal Problems With Covidien, Dräger Ventilators (FierceMedicalDevices) (FDA) (FDA)
  • Effort to Defeat FDA Jurisdiction Based on Club Membership Is Unceremoniously Bounced (FDA Law Blog)
  • Court: Amgen Cannot Stop Imminent Sale of Neupogen Copycat (Reuters)

In Focus: International

  • Policy Prescriptions: the Firepower of the EU Pharma Lobby and Implications for Public Health (Corporate Europe) (EFPIA Response)
  • EC Wants Feedback on Clinical Trial Inspector Expectations (Outsourcing-Pharma)
  • Indian Devices Makers Seek Regulatory Clarity, Ways to Drive Consumption (PharmaBiz)
  • Sierra Leone to Vaccinate 200 Connected to Ebola Victim (Reuters)
  • Japan MHLW Aims for Innovative Drug, Device Funds in Next Budget (FiercePharmaAsia)
  • Singapore Regulators Make Device FSCAs Publically Available (Emergo)
  • Turkish Government Moves to Support Orphan Drugs (PharmAsiaNews-$)

US: Pharmaceuticals and Biotechnology

  • Could 96 Percent FDA Drug Approval Rate Harm Biosimilar Market? (BioProcessOnline)
  • FDAAA Impact Analysis (Year 7): The Era of the “Breakthrough” REMS (RPM Report-$)
  • Sanders sets sights on medicine pricing (PMLive) (Statement)
  • Wright Brings New Biologic To U.S. Ortho Space With Augment Approval (Gray Sheet-$)
  • 5 Things You Didn’t Know about Researching and Developing a New Medicine (The Catalyst)
  • Compressed Medical Gases-Warning Letters for Specific Violations Covering Liquid and Gaseous Oxygen; Withdrawal of Compliance Policy Guide (FDA)
  • Still Waiting: FDA Not Yet Published the HARPC Final Rule (FDAImports)
  • Kim Kardashian’s Corrective Post Gives Duchesnay Drug More Buzz (Pink Sheet-$)
  • FDA May Cut Its Losses In Off-Label Promotion Case (Pink Sheet-$)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Eisai, Purdue Join Up To Take Insomnia Drug Into Phase III (PharmAsiaNews)
  • Support for PrEP in Clinical Setting, As Study Reports No New HIV Infections (MPR)
  • Boehringer touts Pradaxa antidote data as FDA decision nears (FiercePharma)
  • FDA approves Tesaro's treatment for chemotherapy-induced nausea (Reuters) (Press)
  • Enrollment Begins in Cytori Phase III/Pivotal ADRESU Urinary Incontinence Trial (Press
  • Cerecor Initiates Phase 2 Study for CERC-301, an Antidepressant Product Candidate With Potential for Rapid Onset of Effect (Press)
  • Zingo Demonstrates Efficacy for Pain Reduction in Pediatrics (MPR)
  • Protalex to Initiate Enrollment of U.S. Phase I/II Trial of PRTX-100 to Treat Immune Thrombocytopenia (Press)
  • Positive Phase III results demonstrate efficacy of Avycaz (EuropeanPharmaceuticalReview)
  • Gilead's Investigational Fixed-Dose F/TAF Combination Meets Primary Objective in Phase 3 (DD&D) (Press) (Reuters)
  • FDA Approves Updated Labeling for Simponi Aria (MPR)
  • FDA grants priority review for Empliciti Biologics License Application (EuropeanPharmaceuticalReview)

US: Medical Devices

  • FDA Issues Recalls For Alaris Infusion Pumps (Gray Sheet-$)
  • Two Eminent Reasons to Speed Device Approvals (MDDI)
  • AAMI Whitepaper Names Risk Principles for Medical Devices in Postmarket Setting (ICT)
  • 'Heart in a box' reanimates hearts after death, increasing supply of donated organs (FierceMedicalDevices)
  • Nanostim Meets Goals In Short Trial, But Big Questions Remain For Leadless Pacemakers (Gray Sheet-$)
  • Teleflex Receives FDA Clearance for the ARROW® Triple Lumen Pressure Injectable Acute Hemodialysis Catheter (Press)
  • Salutaris Medical Devices Announces 510(k) Clearance (Press)
  • FDA partners with nonprofit device incubator Fogarty Institute to improve approval efficiency (FierceMedicalDevices)
  • 5 Things We Learned From ‘UDI, Wave One' (MedDeviceOnline)
  • 3D Printed Microscopic Microfish to Swim Through Blood Delivering Drugs, Clean Up Toxins (medGadget)

US: Assorted and Government

  • Biosimilar Launch Notification: Celltrion Claims Loophole In Remicade Suit (Pink Sheet-$)
  • Injectable Skin Lightening Products: What You Should Know (FDA)
  • Simulations Plus Awarded New Cooperative Agreement with FDA (Press)

Upcoming Meetings and Events              


  • NICE draft guidance conditionally recommends Vimizim (EuropeanPharmaceuticalReview)
  • NICE issues draft guidance recommending drugs for rheumatoid arthritis (PharmaLetter-$)
  • UK Study Indicates That The Cardiovascular Risk Of Celebrex No Different From Other Pain Drugs (Forbes)
  • New NIBSC director announced (MHRA)
  • NICE Opens Consultation on Upper Aerodigestive Tract Cancer Guideline (NICE)
  • ESCMID Publishes Guidelines Aimed at Preventing Build-up of Dangerous Biofilms (ICT)


  • TGA key performance indicators: January to June 2015 (TGA)
  • Advisory Committee on Medical Devices 20 August Meeting (TGA)


  • Drug sector needs boost to reduce dependency on China: IDMA (Economic Times)


  • CFDA Said Considering Shortening Oncology Drug INDs To 60 Days (Pink Sheet-$)


  • Dissolving stent compares favourably against metal stent in Japanese trial (MNT)

Ebola Outbreak

  • WHO declares Ebola transmission in Liberia over. Nation enters 90-day intensive surveillance period (PharmaAfrica) (WHO)

Other International

  • WHO Moves Ahead On Model Regulations For Medtech (Gray Sheet-$)
  • WHO calls for data sharing “by default” in public health emergencies (AllTrials) (WHO)
  • SE Asian health ministers to meet in Dili (BioSpectrum)

General Health and Other Interesting Articles

  • Outbreak of rare, mutated poliovirus that originated from vaccine in Ukraine leaves two children paralyzed (Washington Post)
  • Regeneron scientists discover key to excess bone growth in rare disease (Reuters) (CBS News)
  • Medicine Has Been Taken From Us, and We Need to Take It Back (MedPageToday)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

Categories: Recon, Regulatory News

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