(redirected from Generic Biological)
A biopharmaceutical or other biological product—e.g., insulin, hGH—that has emerged from patent protection and can be manufactured by a party other than the original developer using either identical or different manufacturing processes; for FDA approval, the product must be bioequivalent or comparable to the original innovative product
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Shapiro's report, entitled The Potential American Market for Generic Biological Treatments and the Associated Cost Savings, also finds that ".
However, I'm sure that they would rather continue to pay for a branded product that has proved to be safe and effective in human clinical trials than to be included later as a subject in a scientific article documenting major safety and / or efficacy deficiency problems in a generic biological product that was approved for use in humans based on poorly thought-out requirements created urgently because of political pressure," he said.
Biosimilars are generic biological drugs that are similar to the original branded products.
The Company has under development four generic biological products, one research monoclonal antibody and four partners' monoclonal antibody products.
Allan stated, "I believe the scientific expertise and capability exist for many companies to manufacture safe and affordable generic biological products.
The sales that biological agents command and the costs that they impose for payers combine to generate intense interest in the development of generic biological agents, or biogenerics.
Waxman's Access to Life-Saving Medicine Act (or subsequent bills), which establishes a framework for the approval of generic biological drugs.
Pharmaceutical patent expirations, generic biological therapeutics, and increasing restraints on reimbursement are only a few of the complex challenges facing competitors today.
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