Biosimilar Interchangeability Guidance Hits the Street

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.

505(j) or 505(b)(2) – What’s Your Poison?

Today, FDA finalized a guidance document (initially issued in draft in October 2017)that discusses how to best determine if your proposed product should be submitted as an ANDA (505(j)) or an NDA (505(b)(2)).  We first blogged about this here.  The selection of the type of application to submit has been a source of discussion ever since the Hatch-Waxman Act of 1984 created the 505(b)(2) process,

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Consumer Antiseptic Rubs Final Rule – or Is It?

Publishing tomorrow, the FDA will announce that 28 ingredients that were considered in the June 30, 2016 proposed rule were given the boot while further consideration of three ingredients (benzalkonium chloride, alcohol (also referred to as ethanol or ethyl alcohol), and isopropyl alcohol) were deferred until the firms had more time to conduct appropriate studies and the Agency has time to review the additional information to be submitted. 

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ANDA Suitability Petitions: The Way Back to Normalcy (and Some Sanity)

Coauthored by Kurt Karst (of FDA Law Blog) and Bob Pollock

The “Petitioned ANDA”—It’s a route to ANDA approval that’s been around since even before the enactment of the 1984 Hatch-Waxman Amendments.  For several years after the enactment of Hatch‑Waxman, the petitioned ANDA was a mainstay of the generic drug industry’s drug development paradigm.  

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FDA Prioritizes ANDA for Valsartan to Avert Shortage

On March 12, 2019, the FDA approved an ANDA for Valsartan “to help relieve the recent shortage of this critical medicine as a result of multiple recalls of generic valsartan products from several manufacturers due to the finding that certain lots of Valsartan and other ARB medicines contain nitrosamine impurities.”  The Agency prioritized the ANDA’s approval but is it not yet clear how quickly the FDA approved the ANDA or when it was submitted as it is not yet listed on the approval site or in the Orange Book.

Compounder of Sterile Products Hit with Consent Decree

A federal judge entered a consent decree to a 503A compounder of sterile drug products in Texas.  According to the FDA News Release (here), the compounding facility received repeated warnings from the FDA over a two‑year period but continued to compound sterile ophthalmic products.  “The government alleges that Guardian manufactured and distributed purportedly sterile drug products that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the FD&C Act.  

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First Time Generic Approvals January to March 8, 2019

Each year, the OGD publishes a list of first-time generic approvals, which are defined by the agency as:

“First generics” are just what they sound like—the first approval by the FDA which permits a manufacturer to market a generic drug product in the United States.  The FDA considers first generics to be important to public health and prioritizes review of these submissions.

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Whoops! February Approval Actions at 99 or 106! But Don’t Be Fooled by the Numbers – Plus January Stat Update

Well, for the first time, our initial estimates of approval actions for a month was higher than the reported official figures, but are they really?  Don’t know exactly how that happened because our estimates are usually below the totals.  Anyway, the official figures posted today (here) were eight-two full approvals and seventeen tentative approvals.  

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Commissioner Gottlieb Resigns – A Blow to the FDA and the Health of the Nation

In my own humble opinion, Scott Gottlieb’s resignation will come as a blow to both the industry and the public health of our nation.  Dr. Gottlieb will stay in his position for about a month.  There is no speculation as to whom his replacement will be, and, while some of the news outlets cite his taxing weekly commute to Bethesda/D.C.

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Final Guidance on Bulk Drugs that Can Be Used for Compounding for 503B Outsourcing Facilities

The FDA has revised and finalized a guidance document, originally issued in draft on March 26, 2018, entitled Evaluation of Bulk Drug Substances Nominated for Use in Compounding under Section 503B of the Federal Food, Drug, and Cosmetic Act (here).  After the posting of the draft guidance, the FDA says that it received approximately sixty comments from stakeholders and,