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However, the safe application of biologics depends on an informed and appropriate use by healthcare professionals and patients. Introduction of biosimilars also requires a specifically designed pharmacovigilance plan. It is difficult and costly to recreate biologics because the complex proteins are derived from living organisms that are ...
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
Specialty drugs patient care management is meant to be both high technology and high touch care, or patient-centered care with "more face-to-face time, more personal connections". Patient-centered care is defined by the Institute of Medicine as "care that is respectful of and responsive to individual patient preferences, needs and values". [27]
They’re a real threat to the U.S. pharmaceutical industry, trade groups warn, one likely to result in medication shortages and higher prescription drug costs, with patients footing the bill.
The safety and clinical performance of both originator and biosimilar biopharmaceuticals must remain equivalent throughout their lifecycle. [ 18 ] [ 19 ] Process variations are monitored by modern analytical tools (e.g., liquid chromatography , immunoassays , mass spectrometry , etc.) and describe a unique design space for each biologic.
The deal "will further strengthen our immunology patient offering and means we now have five potential high-value upcoming biosimilar launches over the next few years," said Sandoz CEO Richard ...
As the primary lobby for makers of generic drugs, [1] AAM's stated mission is to advocate for public policies that facilitate timely access to lower-cost, FDA-approved generic and biosimilar medicines by consumers and patients. Over the 10-year period 2008 through 2018, the use of generic drugs generated $2 trillion in U.S. healthcare savings.
On biosimilars, we are rapidly advancing three Phase 3 programs, evaluating our biosimilars to Opdivo, Keytruda, and Ocrevus, the next wave of Amgen biosimilar products.