In March 2015 the U.S. FDA approved Zarxio (filgrastim-sndz), the United States’ first biosimilar product to earn the distinction. According to the FDA, Sandoz Inc.’s Zarxio is biosimilar to Amgen Inc.’s Neupogen (filgrastim), originally licensed in 1991. At the time FDA Commissioner Margaret A. Hamburg, M.D., explained “Biosimilars will provide access to important therapies for patients who need them. Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.”
Zarxio’s approval, said the FDA, is based on review of evidence that included structural and functional characterization, animal study data, pharmacokinetic and pharmacodynamics data plus clinical immunogenicity data and other clinical safety and effectiveness data. Under the BPCI Act, a biological product that has been approved as an “interchangeable” may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.
Rand Corp.’s study, “The Cost Savings Potential of Biosimilar Drugs in the United States,” notes “the introduction of biosimilars is expected to reduce prices, albeit to a lesser degree than small-molecule generics.” Rand’s analysts explain this perspective combines prior research and recent data to estimated U.S. market cost savings. “We predict that biosimilars will lead to a $44.2 billion reduction in direct spending on biologic drugs from 2014 to 2024, or about 4 percent of total biologic spending over the same period, with a range of $13 billion to $66 billion.” At the time of the study’s release Rand added this caveat: “Actual savings will hinge on the specifics of the final FDA regulations and on the level of competition.”
Forbes magazine contributor David Kroll succinctly reported a bit of truth last March: “… it’s fair to say that manufacturing a biologic agent that acts similarly to the original branded drug is an order of magnitude more difficult and has more places where it can go wrong.” No kidding. It takes a highly competent, experienced player to succeed, and that’s why Seeking Alpha’s analysts singled Amgen out as one biopharmaceutical company well-poised to be an early biosimilars champion.
Amgen has three Phase III candidates right now, including ABP 215, its answer to bevacizumab (Avastin), developed and currently marketed by the Genentech arm of Roche; ABP 980, Amgen’s biosimilar answer to Herceptin, another Genentech/Roche blockbuster; and ABP 501 currently under trial for moderate to severe rheumatoid arthritis, targeting the replacement of AbbVie’s Humira. Seeking Alpha says Amgen’s IPR petition against Humira patents could set a precedent for biosimilars in patent law going forward.
Seeking Alpha says when Amgen reported its second-quarter 2015 results in its earnings call, the company reiterated its focus on biosimilars. “According to a 2014 analysis, it costs Amgen somewhere in the region of $200 million to develop a biosimilar, compared to the average cost-to-market of a new pharmaceutical treatment of $2.6 billion.” The point being that companies with experience innovating and processing biologics have a real leg up when it comes to manufacturing economics, but also the ability to price competitively, and to some minds that might mean more fairly as well.
