When it comes to laws and regulations, what happens in Europe stays in Europe generally, and doesn’t have much bearing on the United States. But a recent win in Europe for U.S. drug maker Hospira could have some implications for the United States as well.
Last month, the company — which specializes in making generic injectable drugs — announced that European Union regulators had approved the continent’s first biosimilar monoclonal antibody.
Biosimilars have been on the market in Europe for several years now, but what’s significant about the approval of Hospira’s Inflectra (infliximab) — a biosimilar version of Merck’s and Johnson & Johnson’s Remicade — is that it marks a big move up the value chain. Monoclonal antibodies, so called because they are produced within genetically manipulated cells that are all clones and part of a single cell line, are considered more difficult to make than other biotech drugs, such as growth hormones and interferons.
The United States, of course, is far behind Europe in the maturity of its biosimilars market. The only biosimilar available here so far is Sandoz’ growth hormone treatment Omnitripe (somatropin [rDNA origin]), a biosimilar version of Pfizer’s Genotropin. That received Food and Drug Administration approval in 2006 under a special, one-off approval pathway. Other than that, the Patient Protection and Affordable Care Act of 2010 contained provisions for an abbreviated approval pathway for biosimilars, though the FDA still has to finish putting together regulations, a process that experts expect to take a few more years.
But regardless of regulatory differences between the United States and Europe, the ability to market biosimilars over there provides important experience for their future marketing over here. By the time the FDA is ready to start looking at abbreviated biologic license applications here, for example, Inflectra possibly will have been on the market in Europe for several years, thus providing significant amounts of clinical data, not to mention the many years’ worth of clinical data for biosimilars already on the market in Europe.
Another potential use of those clinical data is that they might quell some of the concerns about the safety and equivalency of biosimilars that have popped up in the United States lately.
In August, California’s state legislature passed SB 598, a bill that would limit the ability of pharmacists to substitute biosimilars for branded biologics — one of several such bills that have seen mixed fortunes in state legislatures around the country. But the Food and Drug Administration has criticized such bills, saying they undermine trust in biosimilars. According to published reports, an FDA spokeswoman said “efforts to undermine trust in these products” were cause for worry and did not serve patients’ interests.