The Approval Process Of Biosimilar Products Within The...

There are similarities and differences among the regulations addressing the approval process of biosimilar products within the United States, the European Union, South Korea and Japan. This paper will attempt to identify these similarities and differences and determine how best practices can be leveraged among the associated regulatory bodies. The regulatory responsibility of the Food and Drug Administration (FDA) dates back to 1906 with the passage of the 1906 Pure Food and Drugs Act. â€Å"The Pure Food and Drugs Act, prohibited the interstate commerce in adulterated and misbranded food and drugs†. (1) The administration adapted its current name in 1930. A major aspect of the FDA’s mission is to â€Å"protect the public health by ensuring the†¦show more content†¦(4) †¢ â€Å"Animal studies (including the assessment of toxicity)† (4) †¢ â€Å"A clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in 1 or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product†. (4) The following guidance is provided for the selection of reference product: †¢ â€Å"The biological product and reference product utilize the same mechanism or mecha ¬nisms of action for the condition or conditions of use prescribed, recommended, or suggested in the proposed labeling, but only to the extent the mechanism or mechanisms of action are known for the reference product† (4) †¢ â€Å"The condition or conditions of use pre ¬scribed, recommended, or suggested in the labeling proposed for the biological product have been pre ¬viously approved for the reference product†. (4) †¢ â€Å"The route of administration, the dosage form, and the strength of the biological product are the same as those of the reference product† (4) †¢ â€Å"The facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biologicalShow MoreRelatedThe Use Of Biosimilars : The New Frontier Of Decreasing The Cost Of Development And Treatment For Patients Essay2713 Words   |  11 PagesIntroduction: The use of biosimilars is one of the newest advancement in healthcare in treating those with rare diseases. Biosimilars are also known as a follow-on biologic which is a biologic that is a copy of the original product that is manufactured by a different company. A biologic is manufactured in a living system such as a microorganism, plant, or animal cells. Most biologics are very large, complex molecules or mixtures of molecules that are produced using recombinant DNA technology. 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