Biosimilars

20
Sep

Bipartisanism Shows up at House Hearing on PBMs

Yesterday, the Committee on Oversight and Accountability of the House of Representatives issued a press release (here) after the hearing on Pharmacy Benefits Managers (PBMs) and their impact on drug pricing.  The press release is titled “Hearing Wrap Up: Pharmacy Benefit Managers Push Anticompetitive Drug Pricing Tactics to Line Their Own Pockets.”  I guess this […]

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18
Sep
Piggy bank on money concept for business finance, investment and saving

Generics and Biosimilars Reap Huge Saving to Consumers 

Once again, AAM reports the data from the IQVIA 2023 U.S. Generic and Biosimilar Medicines Savings Report (here) which demonstrates the savings power from generic drugs and biosimilars.  The Report indicates that, in 2022, the savings realized from the use of generic and biosimilars hit a record $408 billion, of which $9.4 billion was from […]

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01
Sep
Quality Management Maturity Document Released by FDA

Quality Management Maturity Document Released by FDA

The FDA issued a White Paper titled CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development, designed as the next step in the evaluation of key quality assessments designed to identify a high level of commitment to quality management at a manufacturing firm. In the document, the FDA cautions that “Information […]

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01
Sep

OOS: Whose Line is it Anyway? The Contract Testing Laboratory’s or Sponsor’s?

When it comes to investigating OOS results, a clear line should be drawn between the responsibilities of a contract testing laboratory (CTL) and that of the manufacturer/sponsor. Before we come to the testing part, here are some questions (not all inclusive) to be asked by your firm before selecting a CTL for outsourced testing: (1) […]

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15
Aug

Something’s Not Right Here – How Does This Happen?

On August 8, 2023, Axios reported (here) that the Pentagon began contracting with Valisure, a drug testing facility, to test the generic drugs that it is purchasing.  On August 9, 2023, Bloomberg reported much the same thing in an article titled “Tainted Medicine Fears Spur Pentagon to Seek Outside Testing” (here; subscription required).  Congress has been pushing […]

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27
Jul
Woman worried about bills

BsUFA and MDUFA FY 2024 Fees Published! Good News for BsUFA Fees, Not So Much for MDUFA Fees

The schedules for the 2024 Biosimilar User Fees (BsUFA) (here) and Medical Device User Fees (MDUFA) (here) have been posted on the Federal Register prepublication page and are scheduled for final publication on August 28, 2024.  BsUFA Fees  The Biosimilar User Fee Amendments of 2022 (BsUFA III) authorize the FDA to assess and collect user fees for […]

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21
Jul

Mother Nature Just Can’t Cut the Drug Industry a Break

With the latest news that a tornado severely damaged a Pfizer sterile injectable plant in North Carolina, it is clear that Mother Nature is yet another interloper into the drug shortage problem in the United States.  Ed Silverman, of the publication STAT, reports  that “Among the damaged buildings was a Pfizer plant in Rocky Mount, […]

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17
Jul

AAM Says PBMs May Select the Higher Branded Product to Enhance Their Benefits

Biosimilars are advancing the cause of affordable medications; however, in some instances, patient savings do not appear to be the primary concern of Pharmacy Benefit Managers (PBMs).  The Association of Accessible Medicines (AAM) points to the fact that “[j]ust two weeks ago, the U.S. biosimilars industry entered a new phase when eight biosimilar versions of […]

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