Generic Orphan Drugs: A regulatory and commercial status around the World

Joint Event on 18^th European Biosimilars Congress Joint Event on 35^th Annual European Pharma Congress

April 14-15, 2025 Webinar

Alcala Carmona Luis Gerardo

Mexico

Scientific Tracks Abstracts: J Biomed Sci

Abstract :

If we search for the definition of an “Orphan Drug” we can find that the concept similar around the whole World: medical products that are intended for the diagnosis, prevention or treatment of life-threatening or serious conditions. But the most important part of the definition, and where they are different from other types of drugs, is the fact that orphan drugs are intended for conditions that affect a small percentage of the population. In the European Union this number is no more than 5 in 10,000 people, in Mexico we can find a similar definition, in the USA this number will depend in the current population living inside that country, as the disease must affect 200,000 Americans or less. This kind of dugs usually receive benefits from the different Ministries of Health, such as free appointments to solve doubts, no payment fees, the opportunity to use the original labeling, among others. Although this kind of drugs are pointing a very exclusive market, as the number of patients is reduced compared to a common scenario, it doesn’t mean that there is no room for innovation and to improve the current therapeutic alternatives. In some countries you may be able to register a generic orphan drug, but unfortunately this is not always the case. We will review the current status of the generic orphan drugs in the World, possible alternatives and the regulatory status of this kind of products, with an emphasis in the drugs made with biotechnology.

Biography :

Alcala Carmona Luis Gerardo is a regulatory affairs expert based in Mexico City. During his career, he has shown a strong devotion to bringing into the market medical supplies of the best quality that are safe and effective for the patients. He has built differently proven regulatory strategies for national and international companies, having been able to collaborate with companies from around the World, such as the USA, Brazil, Argentina, Chile, Colombia, France, Germany, The UK, Italy, China, Japan, South Korea, among others. His expertise line includes medical devices, medical drugs, and biotechnology drugs, which include generic and innovative drugs. Having worked with new registers, variations, and renewals. Having been able to collaborate directly with Big Pharma Company, Luis also specializes in newly formed companies, always focusing on the best possible regulatory path and having in mind the safety of the patients, as he always says “We are all potential patients”.