FDA to Publish Biosimilars Labeling, Generic Opioids Guidance Later This Year
US pharmaceutical regulators with the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) say they plan to release two new guidance documents on, separately, the labeling of biosimilar products and how companies can evaluate abuse-deterrent properties of generic solid oral opioid drugs.
News of the new guidance documents, which FDA anticipated will come out before the end of the year, came in an updated "Guidance Agenda" document the agency puts out each year. CDER's current list of documents now contains more than 90 guidance documents it plans to either release or finalize in the coming year.
Biosimilar Labeling
The biosimilar labeling guidance is seen by many industry watchers as particularly important, as it will need to address several critical issues essential to the approval of the US' first biosimilar products, which are already under review by CDER. In particular, FDA will need to decide what "generic" name each biosimilar product will go by. Unlike generic pharmaceutical products, which are identical copies of their chemical innovators, biosimilar drugs have inherent differences relative to the biological drug they reference.
To account for these differences—and the potential for each drug to cause slightly different side effects—some have advocated for biosimilars to contain unique suffixes to make the reporting of adverse events easier.
For more on this debate and its nuances, please see a previous article on the subject here.
Industry watchers will undoubtedly be keeping a close eye on how—or whether—FDA chooses to differentiate biosimilar products from the products they reference in its upcoming guidance, Labeling for Biosimilar Biological Products.
Abuse Deterrence Guidance
A second guidance document just added to FDA's list focuses on the abuse deterrent qualities of generic opioids—long a controversial topic at the agency.
At issue: After an opioid is approved, its manufacturer often works to improve its abuse-deterrent qualities to make it harder to misuse and abuse. However, these new qualities do not necessarily extend the original drug's patent protection or marketing exclusivity. As a result, FDA may subsequently approve drugs generic to the original—i.e. non-abuse-deterrent—opioid drug.
FDA has defended this practice by saying it is up to manufacturers to prove that their new abuse-resistance measures actually live up to their claims and deter abuse, and that without such data it is under no obligation to prevent generic competition.
Some industry trade groups and legislators, meanwhile, have called on FDA to change its standards in light of the potential for these generic drugs to increase rates of abuse. In January 2015, for example, industry groups PhRMA and BIO called on the agency to hold generic opioid products to the same abuse-deterrence standards as the most recently approved abuse-deterrent opioid.
For more on this issue, please read our previous article here.
Now FDA appears poised to weigh in on the issue. Later this year, FDA will publish the guidance General Principles for Evaluating Abuse-Deterrent Properties of Generic Solid Oral Opioid Drug.
Full List of Guidance Documents Planned for 2015
A full list of the guidance documents planned for 2015 may be found below. A fair warning: While FDA says it plans to get to all documents this year, in practice it rarely does.
| Advertising |
|---|
| Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs |
| Direct-to-Consumer Television Advertisements –DTC Television Ad Pre-Dissemination Review Program for Human Drugs |
| Health Care Economic Information in Promotional Labeling and Advertising for Prescription Drugs Under Section 114 of the Food and Drug Administration Modernization Act |
| Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices – Use of Links to Third-Party Sites |
| Manufacturer Communications Regarding Unapproved Uses of Approved Medical Products |
| Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs |
| Biopharmaceutics |
| Bioavailability and Bioequivalence Studies Submitted in NDA’s or INDs for Orally Administered Drug Products – General Considerations |
| Dissolution Testing and Specifications Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutical Classification System Class 1 and 3 Drugs |
| Food Effects Bioavailability and Fed Bioequivalence Studies |
| Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System |
| Biosimilarity |
| Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 |
| Considerations in Demonstrating Interchangeability to a Reference Product Labeling for Biosimilar Biological Products |
| Labeling for Biosimilar Biological Products |
| Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity |
| Clinical/Medical |
| Alcoholism: Developing Drugs for Treatment |
| Common Issues in Drug Development for Rare Diseases |
| Duchenne Muscular Dystrophy and Related Dystorphinopaties: Developing Drugs for Treatment |
| Evaluating Drug Effects on Ability to Operate a Motor Vehicle |
| Exocrine Pancreatic Insufficiency Drug Products: Submitting Marketing Applications and Recommendations for Labeling |
| Head Lice Infestations: Developing Drugs for Treatment |
| Measuring Treatment Benefit in Pediatric Populations: Use of Clinical Outcome Assessments |
| Pregnant Women in Clinical Trials – Scientific and Ethical Considerations |
| Standards for Clinical Trial Imaging Endpoints |
| Sunscreens: Safety and Effectiveness Data for Over-the-Counter Monograph Active Ingredients |
| Ulcerative Colitis: Developing Drugs for Treatment |
| Clinical Pharmacology |
| Clinical Lactation Trials – Trial Design, Data Analysis and Recommendations for Labeling |
| Content and Format of the Clinical Pharmacology Section of a New Drug Applications (NDA) and Biologics License Applications (BLA) |
| Dose Selection in Drug Development |
| Exposure-Response Relationships |
| In vitro Drug Interactions |
| In vivo Drug Interactions |
| Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data Analysis and Impact on Dosing and Labeling |
| Pharmacokinetics During Pregnancy and the Postpartum Period – Trial Design, Data Analysis, and Impact on Dosing and Labeling |
| Population Pharmacokinetics |
| Clinical/Statistical |
| Multiple Endpoints in Clinical Trials |
| Drug Safety |
| Content, Format and Submission of Adverse Event Reports by Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act |
| Modifications and Revisions of Risk Evaluation and Mitigation Strategies (REMS) |
| Safety Assessment for Expedited Reporting for IND Studies |
| Electronic Submissions |
| NDA and BLA Content for Planning and Conduct of Bioresearch Monitoring Inspections (BIMO) for CDER Submissions |
| Providing Regulatory Submissions in Electronic Format – Manufacturing Establishment Information |
| Providing Regulatory Submissions in Electronic Format – Bioanalytical Methods Data Standards |
| Generics |
| Acceptability of Draft Package Insert Labeling to Support ANDA Approval |
| ANDA Submissions Refuse-to-Receive for Typographical Errors and Misplaced Files |
| Complete Assessments for Type II API DMFs Under GDUFA |
| General Principles for Evaluating Abuse-Deterrent Properties of Generic Solid Oral Opioid Drug Products |
| Guidance for Industry on GDUFA Completeness Assessment Checklist for Type II API DMFs |
| Labeling |
| Indications and Usage Section of Labeling for Human Prescription Drugs and Biological Products – Content and Format |
| Pediatric Information: Incorporating into Human Prescription Drug and Biological Products Labeling |
| Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products – Content and Format |
| Pharmaceutical Quality/CMC |
| Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base |
| Appropriate Package Type Terms for Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use |
| Botanical Drug Development |
| Comparability Protocols for Approved Drugs: Chemistry, Manufacturing, and Controls Information |
| Development of Near Infrared Spectroscopy (NIR) Procedures |
| Drug Products Containing Nanomaterials |
| Elemental Impurities in Drug Products Marketed in the United States |
| Environmental Assessment: Questions and Answers Regarding Drugs with Hormonal Activity |
| Established Conditions: Reportable CMC Changes for Approved Drugs and Biologic Products |
| Liposome Drug Products: CMC, Human Pharmacokinetic and Bioavailability; and Labeling Documentation |
| Microbiological Quality Consideration in Non-sterile Drug Product Manufacturing |
| Quality Metrics and Risk-Based Inspections |
| Specified Biotechnology and Specified Synthetic Biological Products – Annual Report |
| Pharmaceutical Quality/Manufacturing Standards (CGMP) |
| CGMP Data Integrity Questions and Answers |
| Current Good Manufacturing Practice for Outsourcing Facilities (Pharmacy Compounding) |
| Repackaging of Certain Drug Products by Pharmacies and Outsourcing Facilities |
| CATEGORY – Pharmacology/Toxicology |
| Nonclinical Assessment of Investigational Enzyme Replacement Therapy Products |
| Procedural |
| Applying the Statutory Criteria for Requiring a Risk Evaluation and Mitigation Strategy (REMS) |
| Compliance Policy Guide: Marketed Unapproved Drugs Section 440.100; Revised Draft |
| Critical Path Innovation Meeting |
| DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers |
| DSCSA Implementation: Products Eligible for Grandfather Status |
| DSCSA Implementation: Standards for the Interoperable Exchange of Information for Tracing Certain Human, Finished Prescription Drugs – Standardization of Data and Documentation Practices |
| DSCSA Implementation: The Product Identifier for Human, Finished, Prescription Drugs |
| DSCSA: Verification Systems for Prescription Drugs |
| DSCSA Implementation: Waivers, Exceptions and Exemptions from Product Tracing Requirements |
| For Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B |
| Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products |
| Information on How to Apply for a CDER Certification of Pharmaceutical Product (CPP) Export Certificate |
| Investigational New Drug Applications Prepared and Submitted by Clinical Sponsor Investigators |
| Mixing, Diluting or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application |
| National Drug Code (NDC) Assignment of CDER-Regulated Products |
| Nonprescription Sunscreen Drug Products – Content and Format of Data Submissions to Support a GRASE Determination Under the Sunscreen Innovation Act |
| Process for Withdrawal of GRASE Request or Pending Request Under the Sunscreen Innovation Act |
| Public Disclosure of FDA-Sponsored Studies |
| REMS Program Evaluation: Assessment Planning and Reporting |
| Special Protocol Assessment |
| Submission of Field Alert Reports and Biological Product Deviation Reports |
| Submission of Study Protocols for Drug Products with Certain Risk Evaluation and Mitigation Strategies for Review by the Office of Generic Drugs |
| Sunscreen Innovation Act Review Process, Including Section 586C(c) |
| Survey Methodologies to Assess Risk Evaluation and Mitigation Strategies (REMS) Goal Related to Knowledge |
| Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategies (REMS) |
| Use of Electronic Informed Consent in Clinical Investigations Questions and Answers |