Biosimilar medicines have been approved and routinely prescribed in Europe for nearly seven years, and creation of a clear pathway for Food and Drug Administration review and approval of generic versions of bioengineered drugs was enshrined into law in the United States with the passage of the Patient Protection and Affordable Care Act nearly three years ago. But IMS Health and other industry experts agree it could still be years before biosimilars are available to pharmacies and patients in this country.
The availability of biosimilars would save health plan payers and patients billions of dollars annually — estimates from various economic impact studies range from $42 billion to as high as $108 billion over the first 10 years they're on the market. The Congressional Budget Office estimated that biosimilar competition would lead to "substantially lower prices" for biotech medicines that can cost thousands of dollars per prescription, with prices for the "me-too" versions of those medicines initially discounted about 25% below the branded versions and prices dropping further as competitive forces fully take hold.
Nevertheless, challenges to the approval and marketing of lower-cost, no-name alternatives to today's biopharmaceuticals are daunting. Would-be manufacturers of these bioengineered alternatives face several hurdles.
One big one: Federal mandates notwithstanding, an abbreviated pathway at the FDA for approval of biosimilars has yet to be established. "As we've been working to address the backlog in applications for new generic drugs, we're also working on creating an abbreviated approval pathway for biosimilar biologics," FDA commissioner Margaret Hamburg told generic industry leaders last year.
But although that approval pathway "was authorized as part of the Patient Protection and Affordable Care Act of 2010," she said, a review and approval regimen for biosimilars is far more complex than that for traditional generic abbreviated new drug applications. There are "scientific issues in determining biosimilarity" and "quality-related issues" to consider, among other issues.
"This will not be a one-size-fits-all program," Hamburg promised. "Our requirements will depend upon the product."
One development that could speed the process was the establishment, for the first time, of a user-fee system for biogenerics, or BsUFAs, as part of the reauthorization of the Prescription Drug User Fee Act in 2012. "BsUFA would collect fees for products under development shown to be biosimilar to or interchangeable with an innovator FDA-licensed biological product," Hamburg said. "The funds would support early meetings with companies."
Meanwhile, "devoid of a specific regulatory pathway, the United States currently has no established industry for biosimilars," IMS Health noted in a report. Nevertheless, IMS reported, "with leading manufacturers, including Pfizer and Merck, already positioned to compete, and patients and health insurers stepping up the pressure for access to low-cost, high-value drugs, the United States is forecast to be the single biggest opportunity for biosimilars by 2020. Whether this opportunity is realized is therefore the most important differentiator between success and failure for biosimilars in the next decade."
An approval process at the FDA isn't the only roadblock biosimilars face on the way to eventual marketing, however. Led by such biotech giants as Amgen and Genentech, the biotech industry is intensively lobbying state lawmakers around the country to block "me-too" competition by restricting the ability of pharmacists to substitute generic versions of biological drugs, even if approved by the FDA.
According to a Jan. 28 report in the New York Times, at least eight states have introduced bills to curb biosimilar competition on patient-safety grounds, and other states are developing similar legislation.
Generic Pharmaceutical Association president and CEO Ralph Neas called the moves "a pre-emptive strike by Amgen and Genentech designed to choke the flow of safe and affordable life-saving biologic medicines to patients even before these products have been approved by the Food and Drug and Administration."
Such efforts, Neas added, "are doubly worrying for state legislators because not only will they slow availability of safe, effective and more affordable therapies to patients, but they also will dramatically decrease the much-needed cost savings that biosimilars will provide. At a time when legislators are desperately seeking ways to keep their state fiscally sound, these bills will encourage needless and wasteful spending on name-brand therapies even after FDA-approved lower cost biosimilar products become available."