Category Archive: Biologics

/ Biologics
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AAM GRx-Biosims Meeting Day One Morning Highlights

By | November 4, 2019 | Biologics, BLA, FDA, Generics, Regulatory Affairs | 1 |

The GRx-Biosims 2019 meeting started off with a meditation and stretching exercise; after that, we had to put our minds to work and begin exercising out neurons.  Anna Abram, Deputy Commissioner for Policy, Legislation, and International Affairs, provided an update on generic drug activity, action plans, and biosimilars.  Key points and highlights were:

  • Record breaking number of ANDA approvals in FY 2019 (935)
  • 125 first-time generic approvals
  • 138 approvals for complex generics
  • 205 product-specific guidances
  • The use of the Mutual Recognition Agreement with the EU on inspections designed to keep regulatory authorities from duplicating inspectional efforts
  • FDA has approved twenty-three biosimilars
  • However,

FDA’s Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovations Act

By | August 27, 2019 | ANDAs, Biologics, BLA, FDA, Generics, NDA | 1 |

Contract Pharma published an article back in March briefing how the FDA will administer the transition of NDAs to BLAs. Facing the future transition of biological products from regulation as new drugs under the FFDCA to regulation as biologics under the PHSA in March of 2020, it is not too early to begin incorporating this [...]

Considerations for Analytical Method Validation Life Cycle Controls

By | August 27, 2019 | Biologics, FDA, Generics | Like |

A question that may be raised by industry professionals is, “How does the upcoming ICH Q14 guideline impact the methods that I currently use?” The FDA’s July 2015 Guidance for Industry: “Analytical Procedures and Method Validation for Drugs and Biologics” references analytical method development, the use of statistical tools during method validation, and life cycle [...]
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ICH Q12 – Ready or Not, Here it Comes!

By | July 30, 2019 | Biologics, CBER, CDER, CMC, FDA, ICH | Like |

California Separation Sciences Society (CaSSS) holds a two-day, highly interactive meeting with attendance from the biotechnology industry and global regulators each summer in the Washington, DC area (i.e., the CMC Strategy Forum).  This year the title of the forum was “The Future of Post-Approval Changes is Coming – Are You Ready for ICH Q12?” and it focused on the draft International Conference on Harmonization (ICH) Q12 guideline (here) which addresses the technical and regulatory aspects of reporting post-approval changes to the regulatory bodies. 

Approval Rate for Therapeutic Monoclonal Antibodies Continues to Grow

By | July 18, 2019 | Biologics, FDA, NDA, Regulatory Affairs | Like |

Now that we have passed the midpoint of 2019, it seemed like a good time to take a look at how the FDA and industry are doing at getting biotechnology product applications approved, and put this into historical perspective.

Between 1965 and the end of Federal Fiscal Year 2013, the FDA had approved approximately 86 therapeutic biopharmaceutical products (TBPs).  

FDA Proposes a Fix for the DMF Issue for “Deemed to Be a License” NDAs

By | June 28, 2019 | Biologics, BLA, FDA, NDA, Regulatory Affairs | Like |

Section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 requires that on March 23, 2020, all New Drug Applications (NDAs) for biological products will be “deemed to be a license” under Section 351 of the Public Health Service Act (PHSA).  In December of last year, the FDA published a final guidance as well as a Questions and Answers guidance regarding the complex logistics of this regulatory transition. 

The Agency Speaks to Its Effort for Modernizing FDA’s New Drugs Regulatory Program

By | June 26, 2019 | Biologics, FDA, New Drugs, Regulatory Affairs | 1 |

Today, in the Federal Register (here), the FDA announced a portion of its continuing modernization plan relative to better assessing its summary of approval that FDA prepares for all new NDA and BLA approvals. The notice asked for public comment on “the Clinical Data Summary Report Pilot program as part of the Agency’s continuous assessment of the efficiency and transparency of the clinical data used in the regulatory decision-making process.  

A Deeper Dive on the Biosimilar Interchangeability Guidance Viewed from Our Biologics Expert

By | May 13, 2019 | Biologics, BLA, FDA, Regulatory Affairs | Like |

On Friday May 10, the FDA published the much-anticipated final version of the guidance document Considerations in Demonstrating Interchangeability with a Reference Product.  We did a general post here  and, while recognizing the final version is similar (highly similar?) to the previous draft from January 2017, a careful review (as outlined here) found several useful and potentially significant changes in the final guidance.

Biosimilar Interchangeability Guidance Hits the Street

By | May 10, 2019 | Biologics, BLA, FDA, Regulatory Affairs, Science & Technology | Like |

The issue of the use of biosimilars and their uptake in the market has been a discussion point since the first biosimilar was approved in 2015.  Today, the FDA issued a long-awaited guidance on how a firm can demonstrate interchangeability of a biosimilar to its reference licensed product. The guidance is titled Considerations in Demonstrating Interchangeability With a Reference Product (which is a bit confusing as it applies only to biosimilars) and can be found here.

Have You Visited the Newly Designed FDA Website?

By | April 30, 2019 | ANDAs, Biologics, Compliance, FDA, NDA, Regulatory Affairs, Science & Technology | 2 |

Well, for us old folks, change is always something that makes us queasy.  The newly-designed FDA website stirred those feeling all over again as we try to navigate the new links and find the information that was once at our fingertips (or at least in our bookmarks).  There were some wrong turns and some dead links along the way,

Changes and Updates to the FDA’s Guidance on Non-Proprietary Naming of Biotech Products

By | March 11, 2019 | Biologics, FDA, NDA, Regulatory Affairs | Like |

On Thursday, March 7, the FDA published a draft supplementary guidance on non-proprietary naming of biological products <here>, which updates the January 2017 Final Guidance on Nonproprietary Naming of Biological Products <here>.  Both of these guidance documents address the FDA’s requirement for including a four-letter nonsense suffix in the proper name for biological products. 

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AAM Annual Report on Generic Drug Savings Hits the Street

By | February 1, 2019 | Biologics, Brand Name Drugs, FDA, Generics, Regulatory Affairs | Like |

Each year, the Association for Accessible Medicines (AAM) publishes its report on generic drug savings (here).  The data is based on the independent IQVIA organization’s findings.  Some interesting findings in the forty-page report are outlined below:

  • 93% of generic prescriptions are filled at $20 or less.
  • The average co-pay of for a generic product covered by insurance is $6.06 compared to an average brand co-pay of $40.30.

Applications Submitted During Shutdown Period and Acceptance Dates

By | January 31, 2019 | ANDAs, Biologics, FDA, Generics, NDA, Regulatory Affairs | 2 |

FDA notes on its User Fee web page (here) that the key date for acceptance of NDAs, BLAs, and ANDAs will be dictated by the first date that FDA could accept fees under the appropriation (after the shut down was over) which is January 28, 2019.  The Agency gives the following advice as to how it will treat fee-paying applications and time periods for which fees must be paid (if not submitted at time of original submission of the application) (please see below):

  • For ANDAs transmitted to FDA during the lapse period,
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