By Anna Rose Welch, Editor, Biosimilar Development
The Boston Globe recently published an article revisiting the industry’s ongoing struggle to determine a labeling system for biosimilars. When it comes to physicians, a survey from the Alliance for Safe Biologic Medicines revealed that a majority of doctors feel the label must identify the drug as a biosimilar as well as contain analytical data proving similarity to the reference product. But on the pharma side of things, the primary struggle for the industry to address is what name will appear on the label itself — a decision that reflects the industry’s insecurity over what seems to be an increasingly destabilizing generics environment.
In fact, over the last few months, the seemingly stable small molecule generics market has been facing what could be a significant upheaval. Back in April, Teva made an unsolicited bid for Mylan, which was quickly turned down because of Mylan’s concerns the deal would lead to antitrust risk and unnecessary product divestitures. Last week, several advocacy groups approached the U.S. Federal Trade Commission (FTC) to urge the commission to ban a deal between the two generics powerhouses. The groups fear that, should a deal happen between the two companies, the resulting company would be a “behemoth” with a “virtual lock on a number of key generics,” reported The Wall Street Journal blog. In fact, the combined company would hold 25 percent of the generics market share, and the groups expect that “no divestiture of specific drugs would be sufficient to replace the loss of competition.”
And now, with the approval of the first biosimilar in the U.S., the biologics market is facing what promises to be its own significant upheaval — starting with the debate over what to name each biosimilar. Those manufacturing the brand name biologics are calling for biosimilars to carry a different International Nonproprietary Name (INN) to make adverse event reporting easier. As one representative from Amgen told The Boston Globe, “An inability to identify specific biologic medicines reliably jeopardizes all biosimilar products equally.” Overall, brand name drugmakers are sticking to the argument that choosing different names is the safest option for patients.
On the other side of the argument, however, generic drugmakers have been arguing that adverse event reporting is already possible because of national drug codes and lot numbers, The WSJ blog reported last month. These generics makers have also voiced concerns that giving biosimilars their own unique names would only confuse physicians, making substitution more confusing (and, therefore, unlikely). When it comes to the prices of the biologics on the market these days — ranging from $16,000 to $600,000 per year — it’s safe to say protecting market share of the reference biologics is likely a big reason brand name makers are so insistent on a different naming system.
In light of these conflicting opinions, last August, WHO took a stab at appeasing the multitude of voices calling for naming clarity in the biosimilar space. WHO’s proposal involved adding a four-letter code, or a Biological Qualifier (BQ), at the end of a biosimilar’s INN. This BQ code would not affect nor be part of the INN and would be assigned randomly. This system would also be voluntary, meaning each country could decide whether it would like to institute this code at the end of each name. However, as the WSJ blog reported last month, the FDA isn’t sold on this approach, calling it a “placeholder” until a long-awaited guidance is released, hopefully by the end of the year.
A few months ago, CNBC published an interesting story highlighting the extensive lengths companies have to go to in order to come up with innovative names for drugs. As more drugs enter the market, naming has become an increasingly complicated task, which is why it seems like this upheaval over biosimilar naming is one struggle industry could potentially be avoiding. In Europe, biosimilars have been on the market for close to 10 years, and they have safely maintained the same names as the reference products. So is the name issue just a “red herring,” as Christine Simmon, SVP for policy at the GPhA, argued? According to Simmon, “Innovator companies have an interest in sowing seeds of doubt” in order to protect market share for their own products. Given the conservative nature of the pharma industry, it makes sense the industry would and should be cautious about the fact there are scientific variations between the reference product and the biosimilar.
But at the end of the day, these treatments undergo clinical trials to determine biosimilarity in treating the targeted indication. Something here is going to have to give, especially as new challenges to the costs of biologics spring up every day. Last week, The Boston Globe reported that the just-approved Orkambi for cystic fibrosis, which boasts a price tag of $259,000 a year, has been challenged by a group of cystic fibrosis doctors. With prices such as Orkambi’s on the market, it’s no wonder that payer Express Scripts has forecasted that biotech drug spending is expected to hit $120 billion by 2024. But with biosimilars on the market, this could all change. According to a recent Sandoz-commissioned study by Rand Corp., biosimilars are expected to incur a $44 billion reduction in healthcare spending, and it seems like they’re already impacting sales of some off-patent biologics. Johnson & Johnson’s latest sales figures for Remicade, for instance, reveal that worldwide sales for anti-inflammatory Remicade saw a 7 percent decline in worldwide sales due to Celltrion’s Remicade biosimilar.
However, J&J’s CEO Alex Gorsky remains optimistic that the biosimilar market will be different than the generics market; in fact, he expects the 70 percent of people being effectively treated by Remicade today will speak for itself and encourage doctors to stick with what they know when it’s time to pull out the prescription pad. Gorsky’s not alone; a recent opinion piece published in JAMA also argued that doctor familiarity/preference and limited competition will make the biosimilar market less threatening than that of the generics market. Indeed, a 2012 survey showed patient/doctor reluctance to switch from brand name to small molecule generics, even though generics are simply identical chemical copies of the brand name drug.
In the end, however, I highly expect it will be hard to overlook the outcries coming from advocacy groups, payers, and patients about the high cost of biotech drugs. Just as WHO sought to come up with a naming system that would meet both brand name and biosimilar manufacturers demands, it’s my bet that introducing competition to the market by assigning the same generic names will be a compromise the industry has to make — and brace itself for — for the sake of the market and their patients.