The global Generics industry has come a long way from a nascent and niche market, to a highly matured and developed market. The reason behind this is, firstly, the increasing cost pressures and demand for bringing affordable medicines to treat the patients. Secondly, the Regulatory support from major Health Authorities and governments in increasing the generic drug adoption, by incentivizing the generic drug manufacturing companies. Health regulators like, the US FDA support manufacturers to gain approval in the US and other markets through international harmonization of technical and scientific standards for the development of generic drugs and provide manufacturers with an opportunity of 180-day exclusivity for generic drugs with Paragraph-4 certifications.
Another key development from Health Regulators in facilitating the generic is to promote the generic drug competition to branded drugs in the areas of complex generics/hybrid generics and to provide clear Regulatory guidelines and policies for delivering safe and high-quality generics.
With understandable Regulatory reforms and large number of patent expiries between the years 2015-2020, there is a huge opportunity for generic manufacturers to produce low-cost alternatives for branded drugs. This means generic manufacturers must capture the market share as quickly as possible before competitors can develop a distinctive image in the market and build the maximum value for their generic drug product.
Freyr’s proven global Regulatory services assist generic pharmaceutical companies to evaluate the protection status of all branded molecules, their Regulatory procedures and market dynamics across all the segments, in order to understand the generics opportunities and gaps in different regions around the world and optimize their service portfolio with an increased margin.