Health & Medicine
Generic Drugs As Effective As Branded, Biologic Counterparts: John Hopkins Researchers
Michael Finn
First Posted: Aug 03, 2016 06:14 AM EDT
The generic drug form of infliximab or Remicade is suggested to be as safe and effective as the branded ones. According to a study conducted by the researchers at John Hopkins University, this would make medication available at a lesser price. However, there are still concerns on the ability to create generic biologic drugs close enough to the brand name originators.
It has been reported that biologics are derived from living cells that require specific manufacturing practices. However, even if it is precisely followed, it can still result to a difference in batches produced since there may be small changes along the process. The changes may then alter the generic drug form. It is, therefore, impossible to create a precise replica.
Despite this concern, researchers at Johns Hopkins believe that the generic drug form is still as reliable. The researchers expect to see more like it due to the myriad benefits it could bring such as lower costs for patients in the drug market. An associate professor at Johns Hopkins and director of the university's Center for Drug Safety and Effectiveness Dr. Caleb Alexander said that their study should reassure clinicians and patients as well as insurance companies that biosimilar TNF-α inhibitors appear comparable to its branded counterparts based on the evidence they have gathered.
The researchers analyzed 19 studies on Inflectra and discovered that the original biologic and the biosimilar were similar in safety and efficacy, Science Daily reported. They have reported that the adverse health reactions were generally mild to moderate in severity. Meanwhile, four of the studies showed patients who found the same drug efficacy and safety when they switched from the original to the biosimilar form.
The generic drug form, Inflectra, a biosimilar for Remicade, has been approved by The U.S. Food and Drug Administration in April, The International Business Times reported. It is a tumor necrosis factor-alpha or a TNF-α, inhibitor used to prevent inflammation, which is a part of treatment for arthritis, IBS and other chronic conditions.
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Tagsgeneric drug, branded drug, John Hopkins, John Hopkins University School of Medicine, Arhtritis, IBS, Chronic Conditions ©2024 ScienceWorldReport.com All rights reserved. Do not reproduce without permission. The window to the world of science news.
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First Posted: Aug 03, 2016 06:14 AM EDT
The generic drug form of infliximab or Remicade is suggested to be as safe and effective as the branded ones. According to a study conducted by the researchers at John Hopkins University, this would make medication available at a lesser price. However, there are still concerns on the ability to create generic biologic drugs close enough to the brand name originators.
It has been reported that biologics are derived from living cells that require specific manufacturing practices. However, even if it is precisely followed, it can still result to a difference in batches produced since there may be small changes along the process. The changes may then alter the generic drug form. It is, therefore, impossible to create a precise replica.
Despite this concern, researchers at Johns Hopkins believe that the generic drug form is still as reliable. The researchers expect to see more like it due to the myriad benefits it could bring such as lower costs for patients in the drug market. An associate professor at Johns Hopkins and director of the university's Center for Drug Safety and Effectiveness Dr. Caleb Alexander said that their study should reassure clinicians and patients as well as insurance companies that biosimilar TNF-α inhibitors appear comparable to its branded counterparts based on the evidence they have gathered.
The researchers analyzed 19 studies on Inflectra and discovered that the original biologic and the biosimilar were similar in safety and efficacy, Science Daily reported. They have reported that the adverse health reactions were generally mild to moderate in severity. Meanwhile, four of the studies showed patients who found the same drug efficacy and safety when they switched from the original to the biosimilar form.
The generic drug form, Inflectra, a biosimilar for Remicade, has been approved by The U.S. Food and Drug Administration in April, The International Business Times reported. It is a tumor necrosis factor-alpha or a TNF-α, inhibitor used to prevent inflammation, which is a part of treatment for arthritis, IBS and other chronic conditions.
See Now: NASA's Juno Spacecraft's Rendezvous With Jupiter's Mammoth Cyclone