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Statistical Methods for Assessing Biosimilarity
Published in Laszlo Endrenyi, Paul Jules Declerck, Shein-Chung Chow, Biosimilar Drug Product Development, 2017
In the early 1990s, as more generic drug products became available, it was a concern whether the use of generic drug products was safe and whether the approved generic drug products could be used interchangeably. The FDA indicates that an approved generic drug product can be used to substitute the innovative (brand-name) drug product. However, the FDA does not indicate that generic drug products can be used interchangeably. Since generic drug products are approved based on the criterion of the 80/125 rule, there may be a drastic change in blood concentration if one switches from one generic drug to another. For example, if one switches from a drug that was approved on the lower end of the 80/125 rule (say 80%) to another drug that was approved on the higher end of the 80/125 rule (say 120%), then there would be a sudden 50% increase in blood concentration, which may cause a potential safety concern. To address the issue of drug interchangeability in terms of drug prescribability and switchability, between the early 1990s and early 2000s, the FDA suggested using the concepts of population bioequivalence for addressing drug prescribability and individual bioequivalence for addressing drug switchability.
FDA regulatory guidance
Published in Sarfaraz K. Niazi, Biosimilars and Interchangeable Biologics, 2016
As indicated by the regulatory agencies, a generic drug can be used as a substitution of the brand name drug if it has been shown to be bioequivalent to the brand name drug. Current regulations do not indicate that two generic copies of the same brand name drug can be used interchangeably, even though they are bioequivalent to the same brand name drug. Bioequivalence between generic copies of a brand name drug is not required. Thus, one of the controversial issues is whether these approved generic drug products can be used safely and interchangeably.
The impact of serialisation on operational efficiency and productivity in pharmaceutical sites: A literature review
Published in Cogent Engineering, 2023
Daniel O’ Mahony, Olivia McDermott, Alan Lynch, Kathryn Cormican
The branded pharmaceutical Industry enjoyed a high-margin environment until the introduction of the Hatch Watchman Act in 1984. This legislation paved the way for generic drug manufacturers to compete with branded drug companies once a medicine no longer had patent protection (Mossinghoff, 1999). The squeeze on margins by generic manufacturers gave pharmaceutical companies a “burning platform” to initiate improvements (Schonberger, 2007). However, by the start of the 21st century, drug companies started to feel the pressure imposed on the industry by generic medicines. Pharmaceutical companies found that their margins quickly eroded once drugs came off patent. As a result, manufacturers needed to adopt lean manufacturing techniques to compete in markets not protected by patents (Bellm, 2015).