With the recent news of cuts in FDA funding (most recently reported by Zachary Brennan in an Endpoints News story entitled, “House Committee Raises Concerns on CDER-CBER Misalignment Amid 2025 Funding Markup” (here, subscription required), the question of FDA being asked to do more must be asked, as it now appears it will have to […]
The FDA released a draft guidance titled Considerations in Demonstrating Interchangeability With a Reference Product: Update (here), which acknowledges the FDA’s continued evaluation of the biosimilar data collected to date and worldwide acknowledgement that if a biosimilar is approved using the analytical methods required for approval, including appropriate in vitro testing, there should be no […]
Each year, the Office of Pharmaceutical Quality (OPQ) releases a report on the state of pharmaceutical quality. This year’s report was released yesterday and can be found here. Every year we try to pick out key issues and highlight some of the statistics outlined in the report, and this year is no different! Some important […]
It’s fascinating to see the evolution and potential future of visual inspection in the pharmaceutical industry. The shift from manual methods to cutting-edge automated systems with artificial intelligence has significantly improved efficiency, accuracy, and reliability in product inspections. By leveraging AI technology in visual inspections, pharmaceutical companies can benefit from enhanced defect detection capabilities, greater […]
A May 28, 2024 review article by Skylar Jeremias titled, “New Evidence Confirms Safe Biosimilar-to-Biosimilar Switching” (here), supports the fact that switching between biologics and biosimilars or from one biosimilar to another does not present a problem. The article states “[S]ince the July 2022 publication of the first systematic review of biosimilar-to-biosimilar switching, the European […]
The Association of Accessible Medicines (AAM) and the BioSimilars Council (a Division of AAM) released a statement of support (here) for a legislative fix to provide a safe harbor for generic / biosimilar label carve-outs. The issue is the potential threat of litigation for inducement to infringe, a problem that could bankrupt a generic or […]
Container Closure Integrity (CCI) testing is a central aspect of contamination control for a product. Contamination control strategy begins with the design, qualification, and validation of a facility, equipment, and processes. Product containers and closures are a crucial element of contamination control. Package integrity is the ability of the package to prevent loss, maintain sterility, […]
In an April 24, 2024 article in Matrix Global Advisors, Alex Brill and Christy Robinson provide an interesting commentary on the Current and Future State of U.S. Biosimilars (here). In the article, they address a number of issues regarding the current biosimilar market and the direction it is taking. They also describe the varied uptake […]
Today, the FDA released a draft guidance titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers (here). Try saying that without taking a breath! This draft is a revision of the initial draft guidance issued on February 4, 2020 (85 FR 6201) (the 2020 draft guidance). The […]
The U.S. Department of Health and Human Services’ (DHHS) strategy for artificial intelligence (AI) is clearly continuing in earnest into 2024. This AI strategy states, “HHS divisions will continue to lead in identifying opportunities for mission-driven AI solutions, mitigating risks appropriately, against a shared framework of federal and HHS guidance.” In alignment with this strategy, […]
