Bioequivalency Manufacturing Regulation 
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). The post The drug industry continues to dare regulation appeared first on World of DTC Marketing.com. At this point, one must wonder why the U.S. About those copay cards.
Drug Patent Watch
DECEMBER 30, 2024
The ANDA must demonstrate bioequivalence to the Reference Listed Drug (RLD), which is the original brand-name drug approved for marketing in Japan. The PMDA evaluates the generic drug based on its chemical, physical, and biological characteristics, as well as its manufacturing process and quality control measures. Freyr Solutions.
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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?
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
These agencies set guidelines and regulations that generic drug manufacturers must follow to ensure that their products are bioequivalent to the innovator drug. Regulatory agencies also conduct inspections and audits to ensure compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) guidelines.
Camargo
DECEMBER 13, 2021
The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610. A 351(k) application is a BLA process submitted by a manufacturer to get a product reviewed as a biosimilar or interchangeable, which is considered to be “highly similar” to an FDA-licensed reference product.
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