April 20, 2018 Presentation to the 11th Biosimilars & Follow-On Biologics 2018 Americas conference on FDA's Policy on Non-proprietary names for Biosimilars
FDA Regulation of Promotion & Advertising -- Part 7: FTC RegulationMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 22, 2018
FDA Regulation of Promotion & Advertising -- Part 6: First Amendment, Off-La...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 23, 2018
FDA Regulation of Promotion & Advertising --Part 2: Direct-to-Consumer AdsMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 22, 2018
FDA Regulation of Promotion & Advertising -- Part 4: FDA Enforcement – Actio...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 22, 2018
FDA Regulation of Promotion & Advertising -- Part 3: Disseminating Scientifi...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 22, 2018
FDA Regulation of Promotion & Advertising -- Part 6: First Amendment, Off-Lab...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 2, 2018, Boston.
FDA Regulation of Promotion & Advertising -- Part 5: Social Media & InternetMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 22, 2018
FDA Regulation of Promotion & Advertising -- Part 1: The BasicsMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston.
FDA Regulation of Promotion & Advertising -- Part 7: FTC RegulationMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 22, 2018
FDA Regulation of Promotion & Advertising -- Part 6: First Amendment, Off-La...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 23, 2018
FDA Regulation of Promotion & Advertising --Part 2: Direct-to-Consumer AdsMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 22, 2018
FDA Regulation of Promotion & Advertising -- Part 4: FDA Enforcement – Actio...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 22, 2018
FDA Regulation of Promotion & Advertising -- Part 3: Disseminating Scientifi...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 22, 2018
FDA Regulation of Promotion & Advertising -- Part 6: First Amendment, Off-Lab...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 2, 2018, Boston.
FDA Regulation of Promotion & Advertising -- Part 5: Social Media & InternetMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 22, 2018
FDA Regulation of Promotion & Advertising -- Part 1: The BasicsMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston.
FDA Regulation of Promotion & Advertising -- Part 1: The BasicsMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 22, 2018
FDA Regulation of Promotion & Advertising -- Part 8: Handling Promotional Co...Michael Swit
This document summarizes a training session on handling promotional compliance at the company level. It discusses that companies need a system with procedures, training, records, audits and validation. It also recommends having a team that includes medical, R&D, regulatory, labeling, marketing, legal, and compliance review promotional materials. Additionally, it outlines key measures companies can take to protect themselves, including implementing an effective compliance program with written policies, a compliance officer, training programs, auditing, and responding promptly to any issues.
FDA Regulation of Promotion & Advertising -- Part 7: FTC RegulationMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,
FDA Regulation of Promotion & Advertising -- Part 4: FDA Enforcement – Action...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston.
FDA Regulation of Promotion & Advertising -- Part 3: Disseminating Scientific...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston
FDA Regulation of Promotion & Advertising --Part 2: Direct-to-Consumer AdsMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,November 1-2, 2018, Boston
FDA Regulation of Promotion & Advertising -- Part 5: Social Media & InternetMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston
FDA Regulation of Promotion & Advertising -- Part 8: Handling Promotional Com...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,November 2, 2018, Boston.
Ensuring FDA Regulatory Success for Biomedical Companies -- Key Lessons for S...Michael Swit
Supporting Materials for Michael Swit's Panel remarks at the Workshop Co-sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group and the Small Business Development Center (SBDC) @ UCI Applied Innovation
Alternative Approaches to FDA Approval for Drug and Device FirmsMichael Swit
This document summarizes alternative approaches for obtaining FDA approval for drugs and devices, including Subpart E regulations, accelerated approval, fast track designation, breakthrough therapy designation, and FDA's review priority system. It discusses provisions of each pathway that aim to expedite development and review, such as early consultation meetings, approval based on surrogate endpoints, and rolling review of applications. The document also provides explanations and examples of key terms used in these pathways.
Medical Device Advertising Law & RegulationMichael Swit
August 17, 2006 presentation to the IVT Medical Device Conference in San Francisco, CA, focusing on:
* Basics of the Law
* Regulation of Promotion/Advertising
* Off Label Promotion & the First Amendment
* Other Legal Concerns Impacting Advertising
* The AdvaMed Code
FDA Regulation of Social Media and the InternetMichael Swit
This document summarizes a presentation given by Michael Swit on legal issues involving social media and FDA regulation. It discusses FDA guidance on social media from 2014, including guidance on submitting promotional materials to the FDA for social media sites owned by companies and those with third party participation. It also summarizes guidance on presenting risk and benefit information for drugs and devices on platforms with character limits like Twitter and sponsored search links.
Labeling/Advertising and Promotion, Import/Export, and Enforcement ActionsMichael Swit
Presentation to the Regulatory Affairs Certification (RAC) Review Course, sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group, on August 2, 2014, in Irvine, CA. See slides 4-58 for Labeling/Advertising Discussion; slide 59 to 72 for Imports/Exports, and 73 to end for Enforcement Actions
Regulatory, Quality & Clinical Due Diligence: The Oft Overlooked Keys to Suc...Michael Swit
June 23, 2010 webinar sponsored by The Weinberg Group, with an emphasis on key issues to explore during due diligence in acquiring FDA-regulated products or companies.
FDA Regulation of Advertising and Promotion -- the BasicsMichael Swit
Presentation to the November 9-10, 2017 Course sponsored by ComplianceOnline, in Boston, MA, focusing on the basics of FDA regulation of drug and device advertising.
Latest Developments in and the Future of the Regulatory Landscape for Approv...Michael Swit
Presentation on "Latest Developments in and the Future of the
Regulatory Landscape for Approving Treatments
for Orphan and Rare Diseases," given at the Orphan Drugs & Rare Diseases -- 2018 Americas West Coast Conference.
June 25, 2018. San Diego, CA.
FDA Regulation of Promotion & Advertising Part 6B: First Amendment, Off-Label...Michael Swit
November 10, 2017 presentation to the ComplianceOnline course on Ensuring Compliance with FDA Regulation of Promotion & Advertising of Drugs and Medical Devices, in Boston.
This document summarizes a presentation about FDA regulation of biosimilars. It discusses how biosimilars differ from traditional generics due to biologics being more complex molecules than small molecule drugs. It outlines the key provisions of the Biologics Price Competition and Innovation Act of 2009, including requirements for biosimilar applications such as analytical, animal and clinical studies demonstrating biosimilarity to the reference product. It also discusses requirements for interchangeability and other miscellaneous rules regarding biosimilar approval pathways.
June 14, 2018 presentation to the San Diego Regulatory Affairs Network (SDRAN) Regulatory Affairs Certification (RAC) Review Course on the basics of FDA regulation of generic drugs and biosimilars.
FDA Regulation of Promotion & Advertising -- Part 1: The BasicsMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 22, 2018
FDA Regulation of Promotion & Advertising -- Part 8: Handling Promotional Co...Michael Swit
This document summarizes a training session on handling promotional compliance at the company level. It discusses that companies need a system with procedures, training, records, audits and validation. It also recommends having a team that includes medical, R&D, regulatory, labeling, marketing, legal, and compliance review promotional materials. Additionally, it outlines key measures companies can take to protect themselves, including implementing an effective compliance program with written policies, a compliance officer, training programs, auditing, and responding promptly to any issues.
FDA Regulation of Promotion & Advertising -- Part 7: FTC RegulationMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,
FDA Regulation of Promotion & Advertising -- Part 4: FDA Enforcement – Action...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston.
FDA Regulation of Promotion & Advertising -- Part 3: Disseminating Scientific...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston
FDA Regulation of Promotion & Advertising --Part 2: Direct-to-Consumer AdsMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,November 1-2, 2018, Boston
FDA Regulation of Promotion & Advertising -- Part 5: Social Media & InternetMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston
FDA Regulation of Promotion & Advertising -- Part 8: Handling Promotional Com...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,November 2, 2018, Boston.
Ensuring FDA Regulatory Success for Biomedical Companies -- Key Lessons for S...Michael Swit
Supporting Materials for Michael Swit's Panel remarks at the Workshop Co-sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group and the Small Business Development Center (SBDC) @ UCI Applied Innovation
Alternative Approaches to FDA Approval for Drug and Device FirmsMichael Swit
This document summarizes alternative approaches for obtaining FDA approval for drugs and devices, including Subpart E regulations, accelerated approval, fast track designation, breakthrough therapy designation, and FDA's review priority system. It discusses provisions of each pathway that aim to expedite development and review, such as early consultation meetings, approval based on surrogate endpoints, and rolling review of applications. The document also provides explanations and examples of key terms used in these pathways.
Medical Device Advertising Law & RegulationMichael Swit
August 17, 2006 presentation to the IVT Medical Device Conference in San Francisco, CA, focusing on:
* Basics of the Law
* Regulation of Promotion/Advertising
* Off Label Promotion & the First Amendment
* Other Legal Concerns Impacting Advertising
* The AdvaMed Code
FDA Regulation of Social Media and the InternetMichael Swit
This document summarizes a presentation given by Michael Swit on legal issues involving social media and FDA regulation. It discusses FDA guidance on social media from 2014, including guidance on submitting promotional materials to the FDA for social media sites owned by companies and those with third party participation. It also summarizes guidance on presenting risk and benefit information for drugs and devices on platforms with character limits like Twitter and sponsored search links.
Labeling/Advertising and Promotion, Import/Export, and Enforcement ActionsMichael Swit
Presentation to the Regulatory Affairs Certification (RAC) Review Course, sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group, on August 2, 2014, in Irvine, CA. See slides 4-58 for Labeling/Advertising Discussion; slide 59 to 72 for Imports/Exports, and 73 to end for Enforcement Actions
Regulatory, Quality & Clinical Due Diligence: The Oft Overlooked Keys to Suc...Michael Swit
June 23, 2010 webinar sponsored by The Weinberg Group, with an emphasis on key issues to explore during due diligence in acquiring FDA-regulated products or companies.
FDA Regulation of Advertising and Promotion -- the BasicsMichael Swit
Presentation to the November 9-10, 2017 Course sponsored by ComplianceOnline, in Boston, MA, focusing on the basics of FDA regulation of drug and device advertising.
Latest Developments in and the Future of the Regulatory Landscape for Approv...Michael Swit
Presentation on "Latest Developments in and the Future of the
Regulatory Landscape for Approving Treatments
for Orphan and Rare Diseases," given at the Orphan Drugs & Rare Diseases -- 2018 Americas West Coast Conference.
June 25, 2018. San Diego, CA.
FDA Regulation of Promotion & Advertising Part 6B: First Amendment, Off-Label...Michael Swit
November 10, 2017 presentation to the ComplianceOnline course on Ensuring Compliance with FDA Regulation of Promotion & Advertising of Drugs and Medical Devices, in Boston.
This document summarizes a presentation about FDA regulation of biosimilars. It discusses how biosimilars differ from traditional generics due to biologics being more complex molecules than small molecule drugs. It outlines the key provisions of the Biologics Price Competition and Innovation Act of 2009, including requirements for biosimilar applications such as analytical, animal and clinical studies demonstrating biosimilarity to the reference product. It also discusses requirements for interchangeability and other miscellaneous rules regarding biosimilar approval pathways.
June 14, 2018 presentation to the San Diego Regulatory Affairs Network (SDRAN) Regulatory Affairs Certification (RAC) Review Course on the basics of FDA regulation of generic drugs and biosimilars.
June 24, 2015 Presentation to the Regulatory Affairs Certification (RAC) Test Review Course sponsored by the San Diego Regulatory Affairs Network, with a focus on regulation of ANDAs, OTC drugs, and Orphan Drugs, covering these issues relating to generic drugs:
♦ Basics
♦ User Fees
♦ Power
♦ Addressing Abuses – by Rule & Statute
♦ Biosimilars – Basics of New Law
Successfully Responding to FDA Inspections (483s) & Warning LettersMichael Swit
This document summarizes a presentation on responding to FDA inspections and warning letters. It discusses Commissioner Hamburg's 2009 speech that revived FDA's compliance culture and enforcement efforts. It outlines FDA's expectations for timely responses to Form 483 observations and warning letters. It provides tips for how companies can prepare for and handle inspections, including designating personnel roles and training employees. It also offers guidance on writing effective responses to Form 483s and warning letters that address each violation, present corrective actions, and minimize future regulatory risks.
Presentation on Critical Legal Issues Facing GMP ComplianceMichael Swit
August 27, 2018 Presentation to the 23rd Annual GMP by the Sea Conference in Cambridge, Maryland, focusing on the potential legal consequences faced by companies that violate FDA's requirements on Good Manufacturing Practices (GMPs) for drugs and biologics
Michael Swit presented at the RAPS Annual Conference in San Jose on October 25, 2010. He discussed the history of biologics regulation and the new pathway for biosimilars established by the Biologics Price Competition and Innovation Act of 2009. The new pathway allows for an abbreviated approval process for biosimilars but gives FDA flexibility in implementation. Biosimilars must show similarity to the reference product through analytical, animal, and clinical studies but may not need to repeat all studies. Interchangeability requires additional evidence and is not required for approval. FDA is seeking input on guidance and other implementation issues.
Presentation at the Biosimilars and Follow-On Biologics 2014 Americas Conference, sponsored by Paradigm Global Events, February 12, 2014. Presentation focused on:
•Interchangeability
•State Substitution Laws
•Naming
•Risk Evaluation & Mitigation Strategies (REMS) and Their Impact on Biosimilars
•Where FDA Stands on Biosimilars
Key FDA Challenges in Bringing Orphan Drugs to the Market in the U.S.Michael Swit
This document discusses key challenges in bringing orphan drugs to market in the United States. It notes that orphan drug exclusivity protects the drug for its orphan indication for 7 years, providing a powerful incentive. It also discusses issues around clinical superiority determinations for similar drugs and the implications of the Depomed/Gralise case. Additional challenges discussed include small patient populations that make clinical trials difficult, as well as ethical and developmental issues in pediatric rare diseases. The presentation provides some suggestions for addressing these challenges, such as alternative trial designs and early, frequent engagement with the FDA.
Combination Products, Orphan Drugs and OTC DrugsMichael Swit
Presentation to the 2016 Regulatory Affairs Certification (RAC) Test Review Course sponsored by the San Diego Regulatory Affairs Network (SDRAN) in July 2017, with a focus on:
A Brief History of Combination Product Regulation
Primary Mode of Action (PMOA) –The Key Lynchpin to FDA’s Regulatory Regime for Combination Products
The Request for Designation (RFD) Process
GMPs
Post-Market Safety Reporting
How Many Applications to File?
User Fees
The FDA Inter-Centers Agreement: Combination Products and the Changed BLA Rev...Michael Swit
This 2003 presentation includes a perspective on the history of FDA regulation of combination products, with a particular emphasis on the changes implemented by MDUFMA in 2002.
Regulatory Considerations in Product DevelopmentMichael Swit
Presentation to the LARTA (www.larta.org) NIH-CAP Workshop in November 2011 on how to develop FDA-regulated products, with a focus on planning, working with FDA,
Update on U.S. Regulation of BiosimilarsMichael Swit
This document summarizes key issues regarding U.S. regulation of biosimilars, including the filing of the first biosimilar applications, requirements for demonstrating interchangeability, state substitution laws, challenges around naming conventions, and arguments on both sides of the naming debate. Industry is pursuing clinical trial designs aimed at demonstrating interchangeability, while FDA guidance is pending and naming remains controversial with pros arguing it ensures traceability and cons arguing it reduces biosimilar uptake.
FDA Regulatory Challenges for Biosimilars and CMOsMichael Swit
Presentation to webinar sponsored by FierceBiotech with a focus on:
* background behind creation of new law
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FDA Regulatory Considerations for Life Sciences CompaniesMichael Swit
April 2008 presentation to Swedish-American Chamber of Commerce Entrepreneurial Days on FDA issues for product development, including focus on:
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GCP Enforcement Trends Lessons Learned from FDA Inspections of Sponsors, Site...Michael Swit
July 21, 2015 Webinar sponsored by FDANews.com, with a focus on:
* How to avoid enforcement by complying
* FDA statistics on enforcement actions in the clinical research arena
* Key observations by sponsor, IRB, and investigator
Combination Products, Orphan Drugs and OTC DrugsMichael Swit
This document discusses FDA regulations for combination products, orphan drugs, and over-the-counter drugs. It provides an overview of combination product regulation, including how the FDA determines a product's primary mode of action and assigns the product to a lead center for review. The document also discusses the request for designation process, Good Manufacturing Practice requirements, and post-market safety reporting for combination products. Finally, it briefly outlines key topics for orphan drugs and over-the-counter drugs.
Presentation at the Center for Professional Advancement (CFPA) Course on Generic Drug Approval, August 2013. New Brunswick, NJ., with a focus on how biosimilars are regulated
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Quality Considerations in Due Diligence for Pharmaceutical TransactionsMichael Swit
The document discusses quality considerations in due diligence for pharmaceutical transactions. It outlines general considerations for due diligence structure and challenges. It emphasizes that quality matters because drugs made in non-compliant facilities can be considered adulterated by the FDA and result in criminal and civil penalties. The document provides examples of problems to look for, including manufacturing, pharmacovigilance, compliance history, FDA inspection history, and audits. It discusses techniques for probing issues, including reviewing FDA correspondence and litigation. Special considerations are outlined for different drug development stages. Helpful charts on diligence issues by stage and analyzing identified issues are presented.
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What’s In a Name? FDA and Non-Proprietary Names for Biologics/Biosimilars
1. Solving FDA Legal Challenges for the Life of a Life Sciences Company -1- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
What’s In a Name?
FDA and Non-Proprietary Names
for Biologics/Biosimilars
Michael A. Swit, Esq.
Michael A. Swit, Esq.
Vice President, Life Sciences
Presentation to the 11th Biosimilars &
Follow-on Biologics 2018 Americas
April 20, 2018
McLean, Virginia
2. Solving FDA Legal Challenges for the Life of a Life Sciences Company -2- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Standard Disclaimers
• Views expressed here are solely mine and do not
reflect those of my firm or any of its clients.
• This presentation supports an oral briefing and
should not be relied upon solely on its own to
support any conclusion of law or fact.
• These slides are intended to provide general
educational information and are not intended to
convey legal advice.
3. Solving FDA Legal Challenges for the Life of a Life Sciences Company -3- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Naming Process
• U.S. Adopted Name (USAN) Council –AMA,
American Pharmacists Assn., USP
– Independent of WHO and INN process
– Drug substances only
– Biologics –
• primary sequence –characteristics of the biopolymer
• if different glycosylation pattern – Greek suffix
• further elements – numbers (Interferon Alfa –2a)
• USP – monographs for drug products as well
– if official, name must be used by approved drug/biologic
• •If no official USP name, FDA picks
4. Solving FDA Legal Challenges for the Life of a Life Sciences Company -4- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Arguments -- Con
• Five key ways drugs are tracked in U.S. – the generic
name is only one aspect of this
– NDC # -- Bar code
– Trade name -- Generic name
– Manufacturer
• Express Scripts to the FTC – we can track every drug
we paid for without reference to INN
• FDA to WHO in 2006
– rejects relying on non-proprietary names relative to
interchangeability
– not needed for AE/PV handling
5. Solving FDA Legal Challenges for the Life of a Life Sciences Company -5- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Arguments -- Con
• Europe
– does not rely on INN for adverse event reporting
– INN is (usually) same for brand and biosimilar
– much greater penetration
• Negative Penetration – data show using different
INNs markedly reduces biosimilar utilization
– Australia
– Japan
– Europe – in cases where there are different INNs (e.g., Hospira’s
EPO zeta) – excluded from tenders
• Prefixes or suffixes – will confuse docs
6. Solving FDA Legal Challenges for the Life of a Life Sciences Company -6- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Pro – Branded Views
• Amgen
– essential to traceability
– asserts naming does not impact utilization
– Physicians favor “similar name” to brand, with “additional
nomenclature” to make clear it is a biosimilar
• Pfizer
– Study – AE’s for small molecule drug with generic competition
• 14% of AE’s not traceable to manufacturer
• only 10% had NDC #’s; 30% of those were inaccurate
– 99% traceable to brand name of maker
– But, not all global jurisdictions – including FDA – can require a
brand name; thus, need a second identifier
7. Solving FDA Legal Challenges for the Life of a Life Sciences Company -7- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
FDA Actions
• August 2015 -- Draft Guidance on Naming (no longer
on FDA’s website) – can be accessed at:
– https://www.fdanews.com/ext/resources/files/08-15/8-15-Biological-Naming.pdf?1520774016
• August 2015 – Proposed Rule to change names of six
products:
– filgrastim-sndz (BLA 125553) filgrastim-bflm = Zarxio® (Sandoz)
– filgrastim (BLA 103353) filgrastim-jcwp = Neupogen ® (Amgen)
– tbo-filgrastim (BLA 125294) filgrastim-vkzt = Granix® (Teva/Cephalon)
– pegfilgrastim (BLA 125031) pegfilgrastim-ljfd = Neulasta ® (Amgen)
– epoetin alfa (BLA 103234) epoetin alfa-cgkn = Epogen® (Amgen)
– infliximab (BLA 103772) infliximab-hjmt = Remicade® (J&J)
NOTE: none changed yet
8. Solving FDA Legal Challenges for the Life of a Life Sciences Company -8- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
The Naming Guidance
• January 2017 – “Nonproprietary Naming of
Biological Products”
– https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation
/guidances/ucm459987.pdf
– Published in the January 13, 2017 Federal Register – 82 Fed. Reg. 4345..
• Bottom Lines –
– “proper name” = “core name” + unique suffix -- of 4
lower case letters -- that is “devoid of meaning”
• example: filgrastim + bflm
– applies to:
• innovator;
• biosimilar; and
• “related biological product”
9. Solving FDA Legal Challenges for the Life of a Life Sciences Company -9- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
FDA’s Rationale
• Will facilitate pharmacovigilance (PV)
• Heighten accurate identification of biologics by
health care practitioners (HCPs) and patients
• Suffixes should help preclude inadvertent
substitution of non-interchangeable products
• Will encourage routine use of suffixes in ordering,
prescribing, dispensing, recordkeeping, and PV
• Will avoid inaccurate perceptions of the safety and
efficacy of biologics
10. Solving FDA Legal Challenges for the Life of a Life Sciences Company -10- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
PV Problems Addressed by Guidance
• PV systems vary in their ability to differentiate between
biologics; current identifiers include:
– proper name, manufacturer, NDC number, Lot number, and billing
codes
• FDA: many systems can not distinguish between
different manufacturers using the same non-proprietary
name (NPN)
• NDC numbers – often not recorded in the clinical
setting or in billing
• Adverse event reports – also often lack brand names
and NDC numbers
11. Solving FDA Legal Challenges for the Life of a Life Sciences Company -11- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Safe Use Goals Served by Naming Scheme
• Inadvertent substitution – seen as being minimized
by the Core/Suffix approach
– FDA -- concerned that physicians, based on their experience
with small-molecule drugs, where the NPNs cover drugs that
are interchangeable, will think they can substitute
• Facilitate use of the “Purple Book”
12. Solving FDA Legal Challenges for the Life of a Life Sciences Company -12- www.fdacounsel.com
LAW OFFICES OF MICHAEL A. SWIT
Naming Scheme Advances Practices and
Perceptions About Biologics
• Avoids inaccurate perceptions of safety and
effectiveness of biologics based on their licensure
pathway
– by applying it to both brand and biosimilar
• Applying to both brand and biosimilar also
– helps prevent a patient from getting a product other than that
which was prescribed
– facilitates manufacturer-specific PV
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LAW OFFICES OF MICHAEL A. SWIT
Developing a Proper Name
• Core name – if available, will use USAN Council
name for the relevant biological substance
– using same core name (e.g., filgrastim) among products with
same biological substance will also help ensure data are kept
together in databases
• contrast: tbo-filgrastim vs. filgrastim
• Suffix
– always will be attached by a hyphen
– if the core name has two parts, suffix gets attached to 2nd part:
• putonastim alfa-jnzl
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LAW OFFICES OF MICHAEL A. SWIT
Developing a Proper Name …
• When to submit: during IND or at BLA
submission
– up to 10 in order of preference
• Suffix requirements
– unique
– devoid of meaning
– 4 lower case letter; only 1 can repeat
– non-proprietary
– use hyphen
– “free of legal barriers that would restrict” use (e.g., trademarks)
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LAW OFFICES OF MICHAEL A. SWIT
Developing a Proper Name …
• Suffix prohibitions
– false or misleading
– includes numerals or symbols
– includes an abbreviation commonly used in clinical practice (e.g.,
bid, daw)
– contain or suggest any drug substance name or core name (e.g.,
nsln)
– resemble or be capable of being mistaken for a currently
marketed product (e.g., alli)
– resemble or connote the license holder
– be too similar to any other FDA-designated NPN suffix
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LAW OFFICES OF MICHAEL A. SWIT
Unresolved Naming Issues
• How to apply suffixes to interchangeable biosimilars
– note the Purple Book uses code “I” for interchangeable and “B”
for the “conventional” biosimilar
• How to deal with already-licensed biologics (other
than the Gang of 6 from the Aug. 2015 Proposed Rule)
– agency did say in guidance it would entertain prior approval
submissions for name changes for such products
• Using same suffix for all products by same company
– see Proposed Rule and how it treats Amgen
• Administrative issues that might be present for the
CDER-approved biologic NDAs that convert to BLAs
on March 23, 2020
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LAW OFFICES OF MICHAEL A. SWIT
Labeling
• Guidance – Labeling for Biosimilar Products –
March 2016 --
https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidan
ces/ucm493439.pdf
• General view on clinical data
– “it is FDA’s view that biosimilar labeling should not include a
description of these data (clinical study of the biosimilar), given
that a clinical study supporting the licensure of the biosimilar
product would not be independently designed to demonstrate
the safety and efficacy of the product…”
– should only be included if necessary to inform safe and
effective use by an HCP
– reason – standard for approval is (a) highly similar and (b) no
clinically meaningful differences
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LAW OFFICES OF MICHAEL A. SWIT
Labeling …
• BUT – agency DOES want you to include:
– a “description of the clinical data that supported safety and
efficacy of the reference product (RP).”
– text does not need to be identical to RP labeling (contrast
Waxman-Hatch rules)
• CAVEAT: strong argument here that the Biosimilar BLA holder
must update labeling before the RP if Biosimilar learns of a
safety issue
• Guidance – contains detail on when to use both the
proprietary and NPN for the biosimilar in the
labeling – usually when:
– the “text is specific to the biosimilar product or refers solely to
the biosimilar product …”
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LAW OFFICES OF MICHAEL A. SWIT
Labeling …
• When to use the RP name:
– when studies or data derived from studies of RP are described,
should use RP name
• Should be specific to conditions of use (e.g., the
biosimilar only has certain approved indications)
• “Biosimilarity Statement” – agency recommends
including a statement, directly below the initial U.S.
approval date in Highlights section of labeling, that the
product is biosimilar to the reference product:
– Example: ZARXIO (filgrastim-sndz) is biosimilar* to
NEUPOGEN (filgrastim) for the indications listed.
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LAW OFFICES OF MICHAEL A. SWIT
Labeling …
• The Asterisk:
– ZARXIO (filgrastim-sndz) is biosimilar* to NEUPOGEN
(filgrastim) for the indications listed.
– * = footnote symbol, with footnote to be added at end of
Highlights section, above the Revision Date, that reads:
• *Biosimilar means that the biological product is approved
based on data demonstrating that it is highly similar to an
FDA-approved biological product, known as a reference
product, and that there are no clinically meaningful
differences between the biosimilar product and the
reference product
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LAW OFFICES OF MICHAEL A. SWIT
Questions?
➢ Call, e-mail or write:
Michael A. Swit, Esq.
LAW OFFICES OF MICHAEL A. SWIT
San Diego, California 92130
m: 760-815-4762
e: mswit@fdacounsel.com
web: www.fdacounsel.com
➢ Follow me on:
– LinkedIn: http://www.linkedin.com/in/michaelswit
– Twitter: https://twitter.com/FDACounsel
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LAW OFFICES OF MICHAEL A. SWIT
About Your Speaker
Michael A. Swit, Esq., has been addressing critical FDA legal and regulatory issues for over 30
years. Before returning to his private law practice in late 2017, he served for 3 years as the chief
regulatory counsel at Illumina, Inc., the world’s leading developer of gene sequencing technologies.
Prior to that, Swit was a special counsel in the FDA Law Practice at the global law firm of
Duane Morris LLP, in its San Diego office. Before joining Duane Morris in March 2012, Swit served
for seven years as a vice president at The Weinberg Group Inc., a preeminent scientific and
regulatory consulting firm in the Life Sciences.
His expertise includes product development, compliance and enforcement, recalls and crisis
management, submissions and related traditional FDA regulatory activities, labeling and advertising,
and clinical research efforts for all types of life sciences companies, with a particular emphasis on
drugs, biologics, therapeutic biotech products, medical devices, and IVDs.
His FDA legal and regulatory work also has included tenures in private practice with McKenna &
Cuneo and Heller Ehrman, and as vice president, general counsel and secretary of Par
Pharmaceutical, a top public generic and specialty drug firm, where he helped spearhead the
company’s emergence from the Generic Drug Scandal. He also was, from 1994 to 1998, CEO of
FDANews.com, a premier publisher of regulatory newsletters and other specialty information
products for FDA-regulated firms.
He has taught and written on many topics relating to FDA regulation and associated commercial
activities and is a past member of the Food & Drug Law Journal Editorial Board. He earned his
A.B., magna cum laude, with high honors in history, at Bowdoin College, and his law degree at
Emory University.