Will purple become the new orange? The new FDA purple book for biologics: what does the future hold?

Abstract

Pharmaceutical Patent AnalystVol. 4, No. 2 CommentaryWill purple become the new orange? The new FDA purple book for biologics: what does the future hold?Anthony D Sabatelli & Cambria J Alpha-CobbAnthony D SabatelliAuthor for correspondence: E-mail Address: asabatelli@dilworthip.comDilworth IP, LLC, 2 Corporate Drive, Suite 206, Trumbull, CT 06611, USASearch for more papers by this author & Cambria J Alpha-CobbDilworth IP, LLC, 2 Corporate Drive, Suite 206, Trumbull, CT 06611, USAYale University, New Haven, CT 06520, USASearch for more papers by this authorPublished Online:8 Apr 2015https://doi.org/10.4155/ppa.14.58AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInReddit View articleKeywords: biologicsbiosimilarsBPCIAgenericsHatch–Waxmaninterchangeablesorange bookpurple bookReferences1 Bayer HealthCare: science for a better life. Small and large molecules: drugs on a chemical and biological basis. www.bayerpharma.comGoogle Scholar2 Federal Food, Drug, and Cosmetic Act (“FFDCA”) §505(j).Google Scholar3 FDA US Food and Drug Administration. Abbreviated New Drug Application (ANDA): Generics. www.fda.govGoogle Scholar4 21 CFR §601.2Google Scholar5 The Biologics Price Competition (BPCIA) amends the Public Health Service (PHS) Act by adding section 351(k), which is analogous to the FFDCA 505(j) ANDA regulatory approval process for generic drugs.Google Scholar6 Strickland I. World Preview 2018: embracing the patent cliff. EvaluatePharma 1–39 (2012).Google Scholar7 Palmer E. The 10 best-selling drugs of 2013. FiercePharma (2014). www.fiercepharma.comGoogle Scholar8 Calo-Fernández B, Martínez-Hurtado JL. Biosimilars: company strategies to capture value from the biologics market. Pharmaceuticals 5(12), 1393–1408 (2012).Crossref, Medline, Google Scholar9 Chance K. The US approval pathway for biosimilar products. Regulatory Focus 15(10), 34–36 (2010)Google Scholar10 Hatch–Waxman Act: Pub. L. No 98–147, 98 Stat. 1585 (1984). The major provisions are codified in the Federal Food, Drug and Cosmetic Act (“FFDCA”), §505 (parallel citation at 21 USC Section 355). The key patent provisions are codified in Title 35 of the United States Code. See, specifically §156 (patent term extension) and §271(e) (patent infringement).Google Scholar11 Center for Drug Evaluation and Research. Questions & Answers - Generic Drugs: questions and answers. www.fda.govGoogle Scholar12 Davit BM, Nwakama PE, Buehler GJ et al. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration. Ann. Pharmacother. 43(10), 1583–1597 (2009)Crossref, Medline, CAS, Google Scholar13 Title VII- Improving Access to Innovative Medical Therapies. Subtitle A- Biologics Price Competition and Innovation. www.fda.gov Google Scholar14 Sandoz v. Amgen, 2014–1693, CAFC (5 December 2014)Google Scholar15 Mallik A. Biosimilars by Sandoz: capturing the future opportunity capturing the future opportunity. www.academia.edu Google Scholar16 §351(i)(3) of the Public Health Service (PHS) ActGoogle ScholarFiguresReferencesRelatedDetailsCited ByAssessment of the differences between generic and biosimilar drugs: A brief literature review17 February 2023 | Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector, Vol. 5Challenges and Benefits of Repurposing Products for Use during a Radiation Public Health Emergency: Lessons Learned from Biological Threats and other Disease TreatmentsRadiation Research, Vol. 190, No. 6Preclinical assessment of abuse liability of biologics: In defense of current regulatory control policiesRegulatory Toxicology and Pharmacology, Vol. 73, No. 1 Vol. 4, No. 2 Follow us on social media for the latest updates Metrics Downloaded 80 times History Published online 8 April 2015 Published in print March 2015 Information© Future Science LtdKeywordsbiologicsbiosimilarsBPCIAgenericsHatch–Waxmaninterchangeablesorange bookpurple bookFinancial & competing interests disclosureThe authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.No writing assistance was utilized in the production of this manuscript.PDF download