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Each year, generics manufacturers offer affordable treatment options for patients and provide needed medication when critical drugs are in short supply. For these manufacturers, the race to be the first to file their drug for FDA approval after the original’s patent expires is critical.
The importance of filing first is complicated by the fact that these drugs, biologics and biosimilars, are increasingly being self-administered by patients via drug delivery systems. Unlike biologics manufacturers that often fold the development of a customized delivery technology into the plan, biosimilar drug makers often rely on “off-the-shelf” systems that are not made specifically for their therapy.
To remain competitive, it is important that generics manufacturers have a plan that will allow them to move quickly to find a way to package and deliver their product. This can be particularly challenging for generics manufacturers given their smaller operating budgets, tight time constraints, and the need to adhere to industry requirements and regulatory restrictions.
In this climate, forging strong partnerships with a drug delivery system manufacturer who is nimble, responsive, and knowledgeable about global regulations can help the drug manufacturer be first to file.
The Generic and Biologic Boom
The generic drug market in the United States is quickly expanding with no signs of slowing down. According to a 2016 study, the global generics market is expected to experience a 10.53 percent compounded annual growth rate (CAGR) from 2016-2020, with the value of drugs coming off expired patents equaling...