Considerations for the evaluation of generic IUDs containing levonorgestrel

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.

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

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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.

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