Which is better, the domestic or imported version of Elastrin?

Elacestrant (Elacestrant) is currently only the original research version on the market worldwide. It was jointly developed by Radius Health and Menarini Group in the United States, and has been approved by the FDA and related agencies in the United States and other countries under the trade name "ORSERDU". The drug is mainly used to treat ESR1 mutant, hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer. It is currently the only approved oral SERD product.

In the domestic market, neither original drugs nor generic drugs are currently officially on the market. As of now, the National Medical Products Administration (NMPA) has not approved Elacestrant’s marketing application, and domestic hospitals and pharmacies are unable to routinely purchase the drug. Some patients may obtain imported drugs through overseas medical treatment, international pharmacies or medical tourism, but this usually requires professional medical advice and medication monitoring support.

From a quality perspective, original drugs are more trustworthy because they have been systematically verified in preclinical and phase III clinical studies, and their efficacy, metabolic pathways, side effect mechanisms, etc. are all clearly scientifically supported. In addition, their production process strictly follows international pharmaceutical production quality standards such asGMP. Although generic drugs can theoretically achieve the same efficacy, no company in the Elacestrant field has completed BE (bioequivalence) testing or obtained approval from the Food and Drug Administration, so they cannot actually supply the drug.

It is worth noting that sinceElacestrant is a small molecule compound, it has the potential to be copied in the future. However, due to the limitations of patent protection period and preparation barriers, it is expected that it will take at least 2-3 years before domestic generic drugs can start clinical trials or even be launched on the market. Therefore, all Elacestrant currently available are imported original drugs.

To sum up, if patients need Elacestrant treatment they should choose legal channels to obtain the original drug based on the evaluation of professional oncologists, and ensure that there are professional pharmacists and doctors to guide the medication. They should not purchase it on their own or take it through informal channels to avoid risks.

Reference ：https://www.drugs.com/mtm/elacestrant.html