>> According to Gottlieb, the plan presented in mid-July is an important part of the government's bold blueprint for reducing drug prices, which also shows the progress that has been made to achieve the results expected by the US President achieve. In doing so, Gottlieb continued, the FDA recognizes the “critical role that Congress has given us to ensure that the United States maintains a robust market for new biologics innovations while at the same time identifying ways to promote timely biosimilar competition to improve the patient access and to reduce costs for patients and our healthcare system. In order to maintain a balance between innovation and competition, the FDA chief believes that regulatory requirements must be modernized in order to "maintain efficient, predictable and scientifically sound ways to review drugs." The US agency's stated goal is to “reduce the time, uncertainty and cost of drug development while creating a competitive market through the efficient approval of low-cost generics, biosimilars and interchangeable alternatives” after patent expiry.
Because that's exactly what's wrong at the moment, at least if you follow the FDA's argument in the recently presented "Biosimilar Action Plan" (BAP). Ultimately, the FDA is comparing the role and savings potential of generics with those of biosimilars. The FDA estimates that the introduction of generic drugs in the US through the Hatch Waxman Act of 1984 would have saved the US healthcare system more than $1 trillion over the last decade, saving $265 billion in 2017 alone -Dollar made possible.1
The FDA now expects something similar from biosimilars. Since biological drugs play a crucial role in the treatment of many serious diseases such as cancer and genetic diseases and are often the only available treatment alternative, they are often very expensive. In fact, according to the FDA, biologics accounted for nearly 40 percent of all prescription drug spending in America and 70 percent of growth in drug spending from 2010 to 2015.2
Against the background of the high costs for the US healthcare system, but also the need to improve access to these important products for patients, Congress passed the “Biologics Price Competition and Innovation Act” (BPCI Act) in 2010, which... introduced a shortened biosimilars-biologics pathway. However, the FDA has not yet had a legal way to follow-up
to approve versions of organic products. FDA Commissioner Gottlieb was concerned that even eight years after the BPCI Act, the market for biosimilars had not yet been established because “the ability of these products to penetrate clinical practice and find acceptance” is still not sufficient be. According to Gottlieb, this is also because the “competition is largely anemic”. And it is anemic because it is more attractive for the entire supply chain, from the manufacturer to pharmacies, corporate purchasing organizations and wholesalers, to achieve monopoly profits through lucrative volume discounts. But also because legal disputes would have delayed market access for biosimilar products that have been available or will soon be available in markets outside the USA for several years.
According to Gottlieb, these delays can result in enormous costs for patients and payers. A comparative FDA analysis of biosimilar competition in all OECD markets shows how high the possible savings would have been, which visualized what would have happened if all biosimilars approved by the FDA in the USA had been marketed here in a timely manner . The number is striking: for 2017 alone it would have been more than 4.5 billion US dollars! Here too, Gottlieb compares the potential but lost savings with those of generics, which accounted for almost $9 billion in 2017 alone. <<