Bioequivalency Manufacturing Medicine 
Pharmaceutical Technology
JULY 25, 2022
With decreasing margins on the horizon, pharma manufacturers have long shown an interest in specialty generics, which is only expected to rise in the future. Despite this, specialty generics are expected to be the domain of a handful of companies with the necessary manufacturing capabilities and legal backing needed for entering the market.
Drug Patent Watch
JANUARY 14, 2025
Case Study 1: Overcoming Formulation Challenges Let’s kick things off with a look at how generic drug manufacturers are tackling formulation challenges head-on. Generic drug manufacturers are taking a similar approach by developing multiple drugs simultaneously[1]. The bone of contention?
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Drug Patent Watch
DECEMBER 12, 2024
Key Factors Influencing Generic Entry To identify branded drugs with a low likelihood of generic entry, it’s crucial to understand the factors that influence generic manufacturers’ decisions to enter a market. This complexity can serve as a barrier to entry for potential generic manufacturers.
World of DTC Marketing
FEBRUARY 21, 2022
Pfizer and Merck have chosen to designate a select few generic manufacturers to produce cheaper versions of their drugs through the Medicines Patent Pool (MPP). Experts across the board are predicting demand for antiviral drugs will rapidly outpace supply. At this point, one must wonder why the U.S. About those copay cards.
Drug Patent Watch
DECEMBER 10, 2024
The Importance of Scientific Expertise Generic drug development involves a deep understanding of the scientific principles underlying drug development, including pharmacology, pharmacokinetics, and bioequivalence. Bioequivalence Studies : Bioequivalence studies are a critical component of generic drug development.
Pharmaceutical Technology
OCTOBER 28, 2022
It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Biosimilars are biologic medical products that almost exactly replicate products already being manufactured by other companies.
Drug Patent Watch
DECEMBER 10, 2024
Food and Drug Administration (FDA) and the European Medicines Agency (EMA) play a vital role in ensuring that generic drugs meet the necessary standards for quality, safety, and efficacy. One of the main challenges is ensuring bioequivalence with the innovator drug. EU, and other regions. ” Scientific Research Publishing , 2024.
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