Fertility regulation benefits the population, protecting the right to life and health, supporting the right of individuals to enjoy their sexuality and the right of children to be born wanted. In addition, it safeguards people’s freedom of conscience to decide whether or not to use a contraceptive method, based on their personal values, safeguards the principle of non-maleficence and the principle of equity and justice. This is fulfilled when services are universally accessible without discrimination and authorities monitor that this condition is respected. Currently, different types of contraceptive methods are available, which are classified into hormonal, barrier, long-acting reversible contraception, emergency contraception and sterilization. All of them must meet the basic conditions of efficacy, safety, acceptability, availability and reversibility.
Considerations for the evaluation of generic IUDs containing levonorgestrel
Generics/Research | Posted 15/10/2021 0 Post your comment
Among the current methods for this purpose are the safe and highly effective intrauterine devices (IUDs). Two types of IUDs are currently available on the market: the T with copper (99.2% effective) and levonorgestrel (LNG) releasing IUDs (99.8% effective). Of the latter type, Mirena, which was developed in the late 1980s and approved in 1993 in several countries outside the US, was the first to be approved by the US Food and Drug Administration (FDA) for marketing in the USA in 2000 and is considered the ‘Gold Standard’. Subsequently, other LNG-IUDs have entered the market after approval by regulatory bodies.
Researchers from Chile discuss the technical considerations when evaluating generic IUDs with LNG for marketing approval [1].
Like conventional drugs, once the patent on LNG-IUDs has expired, health regulators can approve the registration of similar products. The aim of this is to reduce costs, considering the high price of the originator product. However, the unique mechanical properties of the reference product pose a major challenge to similar products.
In the US, LNG-IUDs are registered as new drug applications (NDAs). To date, in Chile, this type of contraceptive falls under the drug category and no evidence of therapeutic equivalence or bioequivalence is required for registration or registration of copies, although FDA does recommend it.
Bioequivalence is a condition that allows the therapeutic equivalence of a similar product to be established through a comparative bioavailability study (or bio-exemptions, when applicable), thus supporting the same efficacy and safety as the comparator or originator product with a view to interchangeability. These studies may be in vivo, in healthy volunteers, in vitro by a test that extrapolates the situation inside the body (e.g. dissolution profiles, permeability tests) or ex vivo, from tissues or samples from individuals to assess local levels of the medicinal product.
The health authority and the various clinical centres should consider that, to date, there are no generics in the world for this type of product and that therefore, their interchangeability should be decided on the basis of in vivo bioequivalence studies, after demonstration of pharmaceutical equivalence in vitro, as suggested by FDA. Alternatively, they should be registered as new products, with appropriate clinical studies demonstrating safety and efficacy.
Conflict of interest
The authors of the research paper [1] declared that there was no conflict of interest.
Abstracted by Luis A Quiñones, Laboratorio de Carcinogénesis Química y Farmacogenética, Dpto. de Oncología Básico Clínica, Facultad de Medicina, Universidad de Chile. Santiago, Chile.
Editor’s comment
Readers interested to learn more about generics pricing in developing countries are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
Strategies for pricing of pharmaceuticals and generics in developing countries
GaBI Journal is indexed in Embase, Scopus, Emerging Sources Citation Index and more.
Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.
GaBI Journal Citation Impact
1.9 – CiteScore 2020 (calculated on 5 May 2021)
2.0 – CiteScoreTracker 2021 (Last updated on 5 October 2021)
Submit a manuscript to GaBI Journal
Related article
Proposals for the commercialisation of generics move forward in Chile
LATIN AMERICAN FORUM The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. View this week’s headline article: Posible colaboración biotecnológica entre India y Colombia Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Vea el artículo principal de esta semana: Posible colaboración biotecnológica entre India y Colombia Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. |
Reference
1. Quiñones LA, Salas-Hernández AV. Análisis y consideraciones técnicas acerca de dispositivos intrauterinos de levonorgestrel para la evaluación de productos similares y genéricos. Revista Médica Clínica Las Condes. 2021;32(4):502-10.
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2021 Pro Pharma Communications International. All Rights Reserved.
Most viewed articles
The best selling biotechnology drugs of 2008: the next biosimilars targets
Global biosimilars guideline development – EGA’s perspective
Related content
Saudi FDA drug approvals and GMP inspections: trend analysis
Generic medications in the Lebanese community: understanding and public perception
Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
Reshaping landscape of Japanese generics market – uncertain future of universal health insurance
Comments (0)
Post your comment