Mexican Drugs and European HurdlesTue, 09/06/2016 - 17:45
Q: What has been BIOSKINCO’s development in other countries such as Germany given your success in Mexico?
FS: We are taking the first steps and the process of registering a product in Europe will take at least three years. BIOSKINCO is opening an affiliate in Germany which will create several possibilities for developing a portfolio of products. The registration process of Epifast®, BIOSKINCO’s blockbuster product, is ongoing but it will take more time.
Q: What barriers have you encountered to launch Epifast® in Europe?
FS: The regulation in Europe is different from that of Mexico and the US. In Europe, Epifast® has to be submitted as a pharmaceutical and that is why it's taking so long. However, in Mexico, Epifast® is registered as a medical device.
There is a worldwide trend in which new therapies that have a sophisticated pathway and include an interaction with the body can be registered as Advanced Therapy Medicinal Products (ATMP). Epifast® is to be considered an ATMP in Europe because it promotes healing of the wounds by the interaction of keratinocyte cells delivering growth factors to the cells remaining in the patient´s wound. This product requires a lot of knowledge to be transferred to doctors so they can learn how to use it.
In Mexico, the production of Epifast® could be developed and done in a university but in Europe this is not allowed. The product has to be manufactured at Good Manufacturing Practice (GMP) facilities. To have it manufactured in a hospital would require an average investment of €5 million (US$5.4 million) plus maintenance that no hospital can afford. This high investment would make the unit price of Epifast® very high.
Q: What is your strategy to ensure the quality of manufacturing at a greater scale to serve those markets?
SV: Epifast® already complies with the internationally accepted standard GMP and therefore can be sold in Europe. Nevertheless, we have to review our production conditions and comply with European GMP auditors. To avoid being labeled as a low-quality product from Mexico it is being redeveloped in Europe and we are in the process of creating a European company. In the meantime, we are working with a Spanish company that will be in charge of the manufacturing in Europe under European GMP standards. We are now transferring technology from Mexico to Europe which we are very proud of.
Q: BIOSKINCO recently announced an increase in Epifast® production by 50 percent. How are you planning to achieve that from an industrial point of view?
SV: We have already scaled up the production of Epifast® by 30 percent for next year. To continue scaling it up by 25 percent per year, we will have to invest in a new facility between 2017 and 2018. In Mexico, we have COFEPRIS certification that is supported by the Ministry of Health. Having the certification gives us the possibility to go to other places in the world but we are required to show the authorities of the new region that we comply with the standards of each country. For instance, the authorities could come visit our facilities and check for their standards. As for Europe we have two options, either comply with their requirements and accept their visit or produce it in Europe under its regulation and best practices.
FS: There are many pharmaceutical companies that want to commercialize products in Europe. But, it seems authorities are becoming stricter regarding quality assurance and regulatory compliance. We are expecting a new regulation stating local manufacture is a commercialization requirement. Therefore, we are planning to manufacture Epifast® in Europe with GMP certification despite higher production costs. At this point, the product is under development in Europe including animal and clinical studies. Authorities recognize that we have done a good job in Mexico, especially after presenting them with a retrospective study and evidence of the positive outcomes the product has had in over 10,000 patients. Data also shows that 50 percent of the patients who received the product are children and no other company is producing such an excellent product for them.