Biosimilars to shake up US drug market in 2023 and beyond despite ‘problem of complexity’
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ORLANDO — Despite the glacial pace of biosimilar uptake in the United States so far, their use is expected to cut drug costs by $54 billion over the next decade, noted a presenter at the 2022 Rheumatology Nurses Society Conference.
“We think biosimilars will drive down drug costs by about $54 billion over the next 10 years,” Christopher Palma, MD, ScM, assistant professor in the department of allergy/immunology and rheumatology at the University of Rochester, in New York, told attendees.
Part of the reason for this optimism, according to Palma, is the expected entry of as many as 11 Humira (adalimumab, Abbvie) biosimilars into the U.S. marketplace through the end of 2023. AbbVie’s blockbuster Humira is currently the highest-grossing drug in the world, netting the company $16 billion in U.S. revenue and $19.8 billion in global revenue in 2020 alone.
In addition, the patent for etanercept (Enbrel, Amgen) is set to expire in 2029, which will no doubt unleash a host of biosimilars for that drug into the market heading into the 2030s, Palma said.
However, whether this savings is actually achieved depends largely on how the regulatory and uptake scenarios play out, he added.
In the meantime, clinicians will be forced to navigate the clinical and regulatory issues surrounding biosimilars every day in the clinic.
“Expect increasing numbers of questions from patients about biosimilars,” Palma said
Almost everything about the production, approval and regulation of biosimilar drugs is complicated, according to Palma.
“This is all a problem of complexity,” he said.
It starts with production — the scale of complexity to produce and manufacture a biosimilar is “degrees of magnitude” more complicated than making a generic drug such as aspirin, Palma noted.
The challenges begin, in fact, with the production of biologic drugs.
“Because they come from living things, biologics inherently contain many slight variations from batch to batch,” Palma said. “Living things, obviously, are extremely complex.”
According to Palma, sugars are added to the proteins in the drugs, which can be a source of variation from batch to batch. In short, even batches of Humira produced in 2022 are different from those produced in 2020.
It follows that the same is true for the production of biosimilars.
Despite these challenges, dozens of biosimilar products have hit the market in Europe and the United States, as clinical trials have shown interchangeability of the bio-originator and biosimilar products.
However, the uptake of biosimilar use in the United States has been slower than it has been in Europe, largely due to reasons associated with this concept of interchangeability, Palma said.
Unlike the approval of generic medications like aspirin, the FDA has demanded a full clinical trial program for biosimilar drugs, including early scientific assessments, studies for toxicity and, ultimately, efficacy trials demonstrating non-inferiority to the original product in terms of pharmacokinetics and pharmacodynamics, C-reactive protein, DAS28 score and treatment emergent adverse events, among other parameters.
However, the challenges do not stop there, according to Palma.
“The process is not the same in every drug, which is unique to biosimilar regulation,” he said. He added that the FDA looks at the specifics of the original drug and allows that to guide the approval process.
Even once interchangeability has been proven and the drug hits the market, regulation, approval and insurance reimbursement issues can vary greatly from state to state, Palma added.
“An interchangeable product may be substituted for the reference product without the intervention of prescribing provider,” he said. “But this policy is not instituted in every state.”
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Palma C. Biosimilars: Where We Have Been and Where We Are Going. Presented at: Rheumatology Nurses Society annual conference; August 3-6, 2022.
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