A federal advisory panel has recommended that the government approve a Novartis cancer drug as a biosimilar alternative to Amgen's Neupogen, which could be the first such designation in a new process intended to foster competition for some of the most expensive drugs in healthcare.
At a Wednesday hearing the Food and Drug Administration's Oncologic Drugs Advisory Committee recommended the agency approve a drug that Novartis plans to call Zarxio.
"We are proud to lead the way in biosimilars globally and believe this positive recommendation brings us one step closer to delivering high-quality biosimilars to patients in the U.S.,” Dr. Mark McCamish, head of global biopharmaceutical and oncology injectables development at Novartis subsidiary Sandoz, said in a statement.
While generics have been on the market as cheaper alternatives to brand-name chemical medicines for decades, biologic alternatives are not identical to their brand-name analogs because they are derived from living organisms.
Biosimilars had no pathway for FDA approval until 2010, when the Biologics Price Competition and Innovation Act of 2009 was enacted as part of the Patient Protection and Affordable Care Act.
An FDA briefing document (PDF) released this week came out in support of approving Zarxio, referred to as EP2006, finding that the drug “meets the requirement for a demonstration of 'no clinically meaningful differences' between the proposed product and the reference product in terms of safety, purity and potency,” the report concluded.
Approval of biosimilars could mean greater access to biologic drugs. Neupogen can run more than $3,000 for 10 injections, and RAND Corp. researcher Andrew Mulcahy estimates Zarxio could be sold at a 35% discount.
“It's an important step toward getting the U.S. biosimilar market kick-started,” Mulcahy said of FDA's pending approval. “But there are still a lot of question marks,” he added. “The next few biosimilars (getting approved) will give us a much better sense for how this market is going to pan out and how much savings there could be for the health system.”
Mulcahy said the introduction of biosimilars into the drug market could save $44 billion over the next 10 years, although he cautioned that the figure relies on a number of contingencies involving the approval process that have yet to be resolved.
One of the biggest questions yet to be answered is how the FDA will address the issue of interchangeability, or the ability of pharmacists to substitute biosimilar drugs for brand-name medications without fear of any adverse effects.
Insurers and pharmacists prefer dispensing generic versions of brand-name drugs whenever possible to cut down on costs. The designation as not only highly similar but also interchangeable could speed the path to market for a number of biosimilars vying for FDA approval, according to Dr. Steve Miller, chief medical officer for Express Scripts, the nation's largest pharmacy benefits manager.
“The uptake (of biosimilars) will be very dependent on if they can get the interchangeability or not,” Miller said. “If you get the interchangeability, that's when we see really high generic utilization rates, without it, you have to go script by script for the change to occur and that will stifle the growth of biosimilars.”
Another issue is the FDA approval process itself. The agency has yet to issue final guidance on how biosimilars will be tested for safety and efficacy. Already the FDA has indicated that the standard will be higher than what's in place for generic drugs, but proponents fear requiring biosimilars to go through a process that mimics the process for a new drug would negate any potential benefit in terms of time and cost.
“We're hoping that it will not be the exact same as an originator product because then you would be ignoring years and years of experience and data that is already known,” Miller said. He said Express Scripts hopes the process is a hybrid of the new-drug application process and the generic-drug approval process “because that hybrid will allow for faster approval at lower costs, which means savings opportunities for both the consumer and the payer.”
Express Scripts estimated in a report released last month that approval of Zarxio could save patients and payers as much as $5.7 billion over the next decade. The report estimated that as much as $250 billion could be saved in the next 10 years if biosimilars for 11 existing biologic drugs are developed and come to market.
But the paths for these drugs are fraught with hurdles beyond FDA approval. Some biologic-drug makers have brought legal challenges to biosimilars that could block their entry to the market for years. One point of contention is the naming of the products. Biosimilar drug proponents contend they should be allowed to carry the same chemical name as the original biologic drug because requiring a similar drug to carry a different name could confuse consumers.
Two other biosimilars have applied for FDA approval. In August, drugmaker Celltrion filed an application for FDA approval of its biosimilar medication to Johnson & Johnson's drug Remicade, used largely for inflammatory conditions such as rheumatoid arthritis. Like EP2006, Celltrion's biosimilar drug, named Remsima, has already been approved and is in use in other countries. The European Union has approved biosimilar drugs for use since 2006, including EP2006 in 2008, which sells under the name Zarzio.
The advisory panel's recommendation does not guarantee FDA approval of the drug, though the agency often sides with the panel in making its determinations.
In response to the panel's decision, the leading trade group for the industry issued a statement calling for the FDA to release final guidance on the processes and criteria for which biosimilars will be considered for approval.
“We believe the appropriate way to develop policy on such a significant new approval pathway is through published guidance documents with the opportunity for public comment, rather than through single-application advisory committee meetings,” Biotechnology Industry Organization CEO Jim Greenwood said in the statement.
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