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Agency precedent for follow-on products approved under FDCA section b 2 is somewhat inconsistent on this issue of citations to the reference product. This caution could lead to regulatory action with respect to the whole class, possibly denying patients access to life-saving medicines that are in fact unaffected by the issue in question. She provides regulatory advice and strategic guidance to pharmaceutical, biotechnology and medical device companies, as well as related trade organizations, on applicable federal, state and local law. For example, USP has thus far issued very few monographs for biologics, but as this changes, FDA may want to work with USP in order to ensure that the monographs do not inadvertently frustrate attempts by the agency to address its pharmacovigilance and inadvertent substitution concerns through naming conventions for biosimilars. As part of this implementation process, FDA should consider commissioning a study focused on healthcare professional understanding of the meaning of biosimilarity, as well as the ways in which the agency can most effectively communicate critical information to all stakeholders. FDA has said very little on this question publicly, but the available—though not entirely analogous—precedents from the FDCA context suggest the approved labeling will be different.

You can add this document to your study collection s Sign in Available only to authorized users. Add Upload document Create flashcards. Changing the nonproprietary name after the product has been on the market could create confusion for healthcare professionals and patients. We focus here in the first instance on the approved professional labeling, or package insert. Aliza Yudkoff Glasner, Esq. The core issue is whether, to what extent and how information in the reference product package insert gleaned from studies of the reference product, the raw data from which remain confidential in the reference product application can and should be reflected in the biosimilar package insert. There are no clinical trials conducted with Omnitrope in adult [growth hormone deficiency GHD ] patients.

Each issue of the Forum presents an important policy topic in the form of a question, provides background information and detailed discussion of the issues involved in the policy question, relevant research, pertinent sources and policy recommendations. We are very lucky to have such great talent join FDLI.

The situation could become particularly complicated if the reference product gains approval for a new indication and the biosimilar sponsor has not yet shown interchangeability for that indication. This in turn could lead to a delay in detecting the safety signal with respect to the one affected product and, in turn, avoidable and potentially quite serious adverse reactions.

Upon your payment of the applicable fees, FDLI grants you the non-exclusive right to retain a permanent copy of the applicable Digital Publication Product and to view, print and use such Digital Publication Product an unlimited number of times, solely for your personal, non-commercial use.

The Membership and Marketing Department has hired more firepower to serve you our members better. The first might be whether the agency should use the package insert to explain the concept of biosimilarity, or whether this information generally should be communicated through another means. She speaks and publishes regularly on these topics. It should be recognised that, by definition, similar biological medicinal products are not generic medicinal products, since it could be expected that there may be subtle differences between similar biological medicinal products from different manufacturers or compared with reference products, which may not be fully apparent until greater experience in their use has been established.

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She has published articles and given speeches on the Biologics Price Competition and Innovation Act of and was involved in various types of advocacy leading up to the passage of the act. FDA has said very little on this question publicly, but the available—though not entirely analogous—precedents from the FDCA context suggest the approved labeling will be different.

As discussed above, many regulatory authorities have already recognized the need to distinguish biosimilars from reference products in some fashion, but the results are often ad hoc and as more biosimilars are approved, the results could be inconsistent. The fee code for users of the Transactional Reporting Service is: Disclaimer The Food and Drug Law Institute, founded inis a non-profit organization that provides a marketplace for discussing food and drug law issues through conferences, publications and member interaction.

Your healthcare professional will always record the exact product you are using. As it implements its biosimilar authority, FDA may be poised to play a key role in this coordination process. FDA should consider using its role on the Council to advocate for a particular naming convention for biosimilars. FDA should also consider how it can work with regulatory agencies around the world, and other international stakeholders, to establish consistent standards for biosimilar naming or to create an efficient mechanism to designate a nonproprietary name for a proposed biosimilar.

Now that you know a little more about FDLI, it is my sincere hope that you get more involved in the Institute this year. Her areas of special focus at this time include biosimilars; the Hatch-Waxman amendments and BPCIA; data and market exclusivities; WHO initiatives relating to drugs and biologics; comparative effectiveness and health outcomes research; supply chain issues e.

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But there are other decisions to be made. And the common stem would allow pooling of adverse events across a product class. The views, opinions and statements expressed in this article are those of the author s. Annual Conference, Advertising and Promotion, Enforcement, Food Week, and our drug, medical device and food introductory programs. Agency precedent for follow-on products approved under FDCA section b 2 is somewhat inconsistent on minograph issue of citations to the reference product.

This caution could lead to regulatory action with respect to the whole class, possibly denying patients access to life-saving medicines that are in fact unaffected by the issue in question. This publication is digital-only, peer-reviewed and smartphone enabled. FDA and other stakeholders have started initial discussions of these issues.

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She will be designing our website, conference themes, book covers, advertisements and much more. He has litigated a variety of cases in the life sciences area, has general trial and appellate experience and works actively on legislative matters.

It recommends that FDA use a transparent process that provides a meaningful opportunity for public input, before making any decisions on these critical issues. At this time, she focuses on, among other things, the regulation of biosimilars and biologics in the United States and foreign jurisdictions, including issues related to data exclusivity, naming and labeling.

The EMA has also used biosimilar product labeling to warn healthcare professionals about similar public safety issues. You can add this document to your saved list Sign in Available only to authorized users. Four in this department are attorneys. You can add this document to your study collection s Sign in Available only to authorized users. The primary debate regarding the naming of biosimilars focuses on whether a biosimilar should be required to have a nonproprietary name that is distinct from that of its reference product.

For example, USP has thus far issued very few monographs for biologics, but as this changes, FDA may want to work with USP in mnoograph to ensure that the monographs do not inadvertently frustrate attempts by the agency to address its pharmacovigilance and inadvertent substitution concerns through naming conventions for biosimilars.

Additional public comment will allow stakeholders to submit detailed proposals representing a multitude of different perspectives, including those of physicians, pharmacists, patients, payers, and innovative and biosimilar companies. Similarly, how biosimilars will be named may affect the design of any pharmacovigilance system put into place for biosimilars.

The Forum welcomes articles on cutting-edge state, national and international policy issues related to food and drug law. Add to collection s Add to saved. Although the WHO has already announced its serifs that biosimilars should have distinct trade names as opposed to distinct nonproprietary namesINNs and USANs, seriws well as other foreign nonproprietary names, have historically been identical in almost all cases.

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Use of Digital Publication Products: Should the Clinical Studies section describe the clinical studies of the reference product, the clinical monoggraph if any that supported approval of the biosimilar product, or both? Following law school, he clerked for the Honorable David M. But the BPCIA as enacted fails to include any provisions related to the labeling and naming of biosimilars or interchangeable biosimilars. Another open question is whether and to what extent the agency should use the biosimilar package insert to communicate advice to healthcare professionals about the implications of possible substitution of biosimilars that have not been found interchangeable.