Streamlining the process of bringing biosimilars to market is one of the keys to facilitating innovation and reducing healthcare costs, according to US Food and Drug Administration (FDA) Commissioner Scott Gottlieb.
Speaking at the Brookings Institution on the release of the FDA’s Biosimilar’s Action Plan, Gottlieb shared recent FDA analysis which suggested that if Americans had the opportunity to purchase successfully marketed FDA-approved biosimilar prescription drugs, more than $4.5 billion could have been saved in 2017 alone.
Biologics represent around 40 percent of total spending on prescription medication, yet these treatments are used by less than two percent of Americans. Between 2010 and 2015, biologics represented 70 percent of the drug spending growth and this sector is set to be one of the fastest growing areas of drug spending in the coming years, Gottlieb forecast.
Biosimilars are similar to generics in that they are a cheaper alternative to a branded product. To gain approval as a biosimilar, drug manufacturers must demonstrate their product is “highly similar” to an already approved biological product.
This differs from generics approvals, which require pharmaceutical firms to demonstrate that their product has the same dosage, safety, efficacy, strength, stability, quality, and route of administration as the brand-name medicine.
Establishing a safe and effective market for biosimilar products could be key to reducing healthcare costs, improving patient access to critical medications, and advancing public health, Gottlieb asserted. He described the increased development of generic therapies, targeted drugs, and other new platforms as “disruptive” suggesting these technologies will “not only improve medical care but also lower healthcare costs”.
“To make sure that the next generation of breakthroughs remains affordable, it requires vibrant competition from biosimilars,” he remarked.
News of the FDA plans to increase competition in the biologics and biosimilars marketplace was cautiously welcomed by the Pharmaceutical Research and Manufacturers of America (PhRMA). "We agree with the administration on the importance of fostering greater competition in the healthcare marketplace ... biosimilars have a crucial role to play in delivering new options to patients and in constraining prescription drug cost growth."
A number of new biosimilar products have already entered the US marketplace in 2018, including Mylan’s Fulphila (pegfilgrastim-jmdb), the first biosimilar for Amgen’s cancer drug Neulasta (pegfilgrastim-jmdb), and Retacrit (epoetin alfa-epbx), a biosimilar produced by Hospira Inc based on Epogen/Procrit (epoetin alfa-epbx) another Amgen product.