Category Archive: Biologics

/ Biologics

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,

Gottlieb Hints at Biosimilar Scare Tactics; Is There Any Surprise Here?

By | January 11, 2019 | Biologics, FDA, Regulatory Affairs | Like |

Shortly after the 1984 Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman) was passed (the legislation that greatly expanded the universe for generic drug products), and even before the first generic under the new legislation was passed, a campaign was initiated to undermine the public’s confidence in generic drugs.  Major pharmaceutical companies began petitioning the Agency with frivolous claims that the system for determining bioequivalence was not sufficiently robust to clearly determine that a generic was truly therapeutically equivalent to its brand name counterpart.

Big Year for NMEs at FDA

By | January 8, 2019 | Biologics, FDA, FDA, NDA, Regulatory Affairs | Like |

In 2018, the FDA says it approved fifty-nine new molecular entities, which included a whopping thirteen biosimilar products.  All of the NME product approvals can be found here.

It is important for you the read the FDA explanation of how the Agency is defining NMEs for the purposes of this report and stay focused on the regulatory implications versus the practical implications of how the FDA is classifying this term. 

Happy Holidays from Us to You!

By | December 20, 2018 | ANDAs, Approvals, Bioequivalence, Biologics, Chemistry, Combination Products, Complex generics, Compliance, Compounding, Data Integrity, Dietary Supplements, eCTD, FDA, FDA, Generics, Guidance, Manufacturing, NDA, News, OTC, Regulatory Affairs, Science & Technology, Shortages, Training, Uncategorized, User Fees, Validation | Like |

To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year.  The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as we follow the ever-changing landscape of FDA regulatory science,

FDA Publishes a Bonanza of Regulatory Documents on Biotech Products – a Deeper Dive

By | December 13, 2018 | Biologics, FDA, Generics, NDA, Regulatory Affairs | Like |

Many thanks to the FDA for publishing several important new and revised guidances and a proposed rule related to the Biopharmaceutical industry this week.  These include a finalized version of the “Deemed to be a License” Guidance for industry (here) with several important revisions and additions relative to the previously published draft,

Q&A Document on the Transition of Certain Protein Products Approved Under Section 505 of the Act to Deemed Approved Licensed Product

By | December 11, 2018 | Biologics, Compliance, FDA, NDA, Regulatory Affairs | Like |

Well, since the first draft guidance on the “deemed approved” transition provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), we have been waiting to learn more about the specific process and for answers to a number of questions.  FDA just issued a second revision of the question and answers document (here). 

FDA Collection of Information FR Notice Provides Some Interesting Estimates

By | November 7, 2018 | ANDAs, Biologics, FDA, Generics, NDA, Regulatory Affairs | 1 |

The Federal Register’s (FR) pre-publication page today contained an interesting proposed renewal for the collection of information for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (here).  The notice states that:

Establishment registration information helps FDA identify who is manufacturing, repacking, relabeling, and salvaging drugs and where those operations are performed.  

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Me KASA es Su KASA – Long Overdue but Very Welcome

By | September 25, 2018 | ANDAs, Biologics, FDA, Generics, Regulatory Affairs | 2 |

On Thursday (September 20th), the FDA held a meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee to discuss the Agency’s plans for implementation of the Knowledge‑aided Assessment and Structured Application program (KASA).  The FDA presented to the Advisory Committee two primary goals of the KASA program.  On the one hand, it is intended to make the review of the CMC section of NDAs,