From Innovative to Generic: The Race Everyone Wants to WinBy Miriam Bello | Tue, 09/14/2021 - 12:05
Increasing access to healthcare is a major challenge, especially for a country that has one of the largest out-of-pocket expenditures in the OECD. Generic medications are significantly less expensive than their patented counterparts, providing relief for cash-strapped households. Beyond cost-savings, generics also represent an attractive market opportunity in which the first company to launch a generic alternative stands to gain the largest share of the pie.
The generics industry has boomed in Mexico as patents for innovative drugs expire. Estimates suggest that nine out of 10 drugs sold in Mexico are generic and, thanks to their lower cost, these medicines represent more than half of the pharmaceutical industry market in Mexico by value. This figure may change depending on the development of new competing drugs in the innovative segment.
The growth of the national pharmaceutical industry through the development of generic products is crucial to the population's access to health. But it is not a short or easy path. For a generic medicine to enter the market, it is necessary to verify it is equivalent to the innovative or reference medicine, in addition to demonstrating its safety and efficacy. The equivalence of a generic medicine with the patented original introduces important challenges for all technical and documentation areas of a company, mainly due to the obstacles presented by the physicochemical characteristics of the product and its integration into a pharmaceutical form.
Innovative drug laboratories also put up several barriers to generics through patent extensions. Patents are essential to innovation as they grant limited and temporary legal protection over the technical aspects of any invention to cover the R&D expenses incurred by the developer. By giving a period of sales exclusivity, patents allow the owner to recoup the cost of developing the product and promote the creation of new inventions. However, using patents as a competitive tool to delay the launch of generic products to the market is quite common.
Generic companies often race to obtain a privileged place in the market by launching the first generic product, which involves the collaboration of multidisciplinary teams that were not previously considered part of pharmaceutical development. The process has incorporated raw material suppliers, which in consideration of the previous challenges have developed strategies to support the development of generics.
Grupo CPQ is an example of this effort, standing out thanks to its collaboration with the pharmaceutical sector in the early development of generic drugs. For over 35 years, Grupo CPQ has been a consolidated distributor of raw materials and active ingredients for different industrial sectors. Along the way, it has become an important part of the supply chain for the pharmaceutical industry. Aware of the importance of the accelerated development of generic products, Grupo CPQ recently developed an innovation area focused on supporting the areas involved in the development of new generic products to overcome the obstacles that hold back their launch to the market.
One of the main obstacles to the launch of generic drugs is the intellectual property strategy of innovative companies, which focus on protecting different characteristics of the active principle, such as salts or crystalline structures. Grupo CPQ has adopted this challenge as its own and, as part of its evolution, has committed itself to distributing active ingredients. This means its buyers do not need to worry about the issue related to the patents involved. In addition, Grupo CPQ provides advice regarding intellectual property to accelerate the development and launch of generic products.
Wider access to health for the broader population becomes more likely with readily available generics. While the process is challenging, Grupo CPQ understands that the solution requires a long-term commitment and a technical and creative approach.