You can submit comments on any directive at any time online or in writing (see 21 CFR 10.115(g)(5)) Pharmacists will play an important role in educating patients and healthcare providers about adding unique suffixes to biologics. These unique suffixes will also allow pharmacists to play a leading role in the implementation and reporting of information on adverse events related to biologics. Pharmacists should also be familiar with the nomenclature for the creation of organic product names, as it allows them to decipher the new origins of organic products and relative indications by breaking down the proper name. Pharmacists must also act as experts on the Purple Book, a reference for all authorized biologics and approved biosimilars and interchangeable biologics. As the number of organic products has increased, the name has become more and more complex. WHO has long been responsible for the assignment of non-exclusive international names. These non-exclusive names (generic or real) refer to the unique component of the active ingredient of the drug, which may correlate information about the chemical name or, in the case of larger biological molecules, information about the nature of the complex molecule.7 It is not the protected name (trademark) that is a registered trademark or registered trademark for private use. The real name helps healthcare professionals and patients identify the product and helps distinguish products from each other.1 This guide was then open for public comment, and an updated version was later published in March 2019.2 This article discusses the FDA`s concerns and proposed solutions, as well as the nomenclature used to name organic products. In 2017, WHO updated the guidelines for the use of IUU, which included summary information on the nomenclature of organic products. In particular, the designation of organic products refers to structure and/or function, and each is assigned a certain group of letters or strain, although not all groups of biological agents have been given a strain (e.B.

Insulins).1 TABLE 2 gives examples of biological groups with their associated strain.4 There are also groups of biologics to which a scheme has been assigned. The regimens include cell therapies, gene therapies, and monoclonal antibodies.4 Nomenclature patterns of these therapies with examples can be found in TABLE 2.4 Biologic drugs are typically large, complex molecules. These properties lead to potential safety issues, especially with the possibility of an immune response. These concerns led the FDA to produce a guidance document for the non-exclusive naming of biologics.1 The document addresses the need for biologics to have a non-exclusive name that contains a unique suffix. The FDA`s intention to add the unique suffix to the proper name of each new biologic is to (1) prevent a patient from receiving a drug that has not been prescribed the intended biologic, and to avoid changing or changing biologics that are not considered interchangeable; (2) enable manufacturer-specific pharmacovigilance monitoring; and 3) Implement these unique suffixes when ordering, prescribing, classifying and keeping records.1 The World Health Organization (WHO) has developed several guidelines for naming biologics. The first was published in 2011; Reference is made to the last editions of 2016 and 2017 in this article. Those documents shall cover the name of the organic products, in particular as regards the generic or correct name of the organic product. WHO documents describe how the proper name should be structured to allow for consistency between organic products.3,4 1. FDA.

Non-exclusive naming of organic products – Industry Guide. 2017. www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM459987.pdf. Accessed March 24, 2020.2. FDA. Non-exclusive naming of organic products – Industry Guide. Draft guide. 2019.

www.fda.gov/media/121316/download. Retrieved 24 March 2020.3. World Health Organization. International Nonproprietary Names (INNs) for biological and biotechnological substances (review). 2016. www.who.int/medicines/services/inn/BioReview2016.pdf. Retrieved March 31, 2020.4. World Health Organization). Guidelines for the use of international nonproprietary names (IUU) for pharmaceutical substances.

2017. www.who.int/medicines/services/inn/innguidance/en/. Retrieved 31. March 2020.5. FDA. Centre for Evaluation and Research of Biological Products (CBER). What are the questions and answers about “organic products”? 2018. www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/what-are-biologics-questions-and-answers. Accessed March 25, 2020.6. FDA. Organic and interchangeable products. 2017.

www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products. Accessed March 26, 2020.7. Jones TD, Carter PJ, Plückthun A, et al. NINs and antibody outputs are not property names. mAbs. 2016;8( 1):1-9.8. FDA. Information on biosimilars. 13 May 2020. www.fda.gov/drugs/biosimilars/biosimilar-product-information.

Accessed May 15, 2020.9. FDA. Purple Book: Database of licensed organic products. Updated may 11, 2020 purplebooksearch.fda.gov/. Accessed May 13 2020.To comment on this article, contactez-rdavidson@uspharmacist.com. Biologics, also known as biologics, are manufactured using biotechnology or other advanced technology. Biologics include blood, blood components, body cells, gene therapy, tissues, recombinant proteins and vaccines and are generally derived from microorganisms, plant, animal or human cells.5,6 Biologics consist of sugars, proteins, nucleic acids or complex combinations of these substances.5,6 These guidelines are intended to provide applicants and other stakeholders with compliance existing safety reporting requirements. of the FDA for humans after placing on the market. marketed drugs and biologics under 21 CFR 310.305, 314.80, 314.98, 600.80 and 600.81.2 According to these regulations, post-market safety reports must be submitted to the Agency for: 1. .

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