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Forti Publications
Biotechnology and Biologic Products Regulation
Biotechnology and Biologic Products Regulation
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This volume focuses on major issues concerning biologics. Did you know that according to a recent Congressional Research Report, the projected percentage increase of biotechnology products including bioengineered vaccines and biologics is predicted to increase to nearly 50% by 2018. To that end, this volume includes a strategic goal plan for the Center for Biologics Evaluation and Research (CBER). The authority of CBER stems from the Public Health Services Act (PHSA) and specific sections of the United States Food Drug and Cosmetic Act (FDCA). Both the PHSA and FDCA impact on these regulated products. Critical parameters in the regulation of these products remains science based to assure purity, potency, safety, efficacy, and availability.
Biologics, result from living sources such as humans, animals and microorganisms unlike conventional drugs, which are chemically synthesized. Biologics involve complicated mixtures and are produced using biotechnology. Biologics include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues.
Generic versions of biotech drugs referred to as biosimilars or follow-on biologics present an interesting and complex issue for both industry and FDA. Biosimilars have become a multi-billion dollar market. Congress passed the Biologics Price Competition and Innovation Act (BPCI or Biosimilars) Act, included as Title VII of the Patient Protection and Affordable Care Act of 2010 Pub.L. 111-148 as amended by the Health Care and Reconciliation Act of 2010 (Healthcare Reform Act). The Biosimilars Act established a 12-year exclusivity period before biosimilars can be approved for marketing in the United States.
Special topics besides biosimilars include bioterrorism, the “Practice of Medicine” and botulinum Toxin Type A “Botox”. Examples of voluntary recalls, gene therapy initiatives and warning letters are included. Each chapter contains critical analysis issues to explore. Finally, a far reaching United States Supreme Court decision occurred in 2013. In Association for Molecular Pathology v. Myriad Genetics the issue hinged on whether naturally occurring human genes and/or isolating those genes from the body were a patentable invention. The United States Supreme Court pronouncement in Myriad is included.
Biologics, result from living sources such as humans, animals and microorganisms unlike conventional drugs, which are chemically synthesized. Biologics involve complicated mixtures and are produced using biotechnology. Biologics include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues.
Generic versions of biotech drugs referred to as biosimilars or follow-on biologics present an interesting and complex issue for both industry and FDA. Biosimilars have become a multi-billion dollar market. Congress passed the Biologics Price Competition and Innovation Act (BPCI or Biosimilars) Act, included as Title VII of the Patient Protection and Affordable Care Act of 2010 Pub.L. 111-148 as amended by the Health Care and Reconciliation Act of 2010 (Healthcare Reform Act). The Biosimilars Act established a 12-year exclusivity period before biosimilars can be approved for marketing in the United States.
Special topics besides biosimilars include bioterrorism, the “Practice of Medicine” and botulinum Toxin Type A “Botox”. Examples of voluntary recalls, gene therapy initiatives and warning letters are included. Each chapter contains critical analysis issues to explore. Finally, a far reaching United States Supreme Court decision occurred in 2013. In Association for Molecular Pathology v. Myriad Genetics the issue hinged on whether naturally occurring human genes and/or isolating those genes from the body were a patentable invention. The United States Supreme Court pronouncement in Myriad is included.
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