By Kathleen P. Wolff, MBA
Specialty Pharma Journal
Forging a pathway of innovation is typically easier with friends and allies. But these days, in the world of biosimilars, where stakeholders are still sizing each other up, allies are scarce. At the Biosimilars 20/20 conference in Philadelphia, the consensus among key opinion leaders was that managed care is now leading the charge, for the most part, on its own.
“When you think about it, why should the physicians support it?” Said Steve Miller, MD, MBA, Senior Vice President and Chief Medical Officer of Express Scripts. Dr. Miller cited the process which may include the doctor’s need to review clinical data, discuss substitution with a pharmacist and explain the switch to their patients. “Physicians will see it as more work,” said Dr. Miller, who has taken a lead role in the promotion of legislation to create a regulatory pathway for biosimilars in the United States.
As for patient advocacy groups, Dr. Miller says he anticipates little support there either. Some advocacy groups are not yet convinced of the safety. Despite the costs savings, which may make the biologic medicines more widely available, there is still substantial doubt in the marketplace, even though the approval process is the same.
“If you look it, it’s the same FDA, it’s the same reviewers approving these products, they’re approved at the same standards, they have to be as safe, pure and potent, and they will be subject to GMPs and inspections of facilities. Everything is the same,” said Gillian Woollett, MA, D. Phil, Senior Vice President, Avalere Health. Dr. Woollett, said in an interview with Specialty Pharma Journal (SPJ). Additionally, she emphasized the need for education, saying, “All the data on the originator product is by definition supportive of the safety, purity and potency of the biosimilar because that’s what FDA is using as a basis of the approval of the biosimilar.”
Developments in recent months seem to suggest new era in biosimilar development and use in the U.S., which has lagged significantly behind the rest of the world. The approval of filgrastim-sndz, (Zarxio, Sandoz) approved by the U.S. Food and Drug Administration on March 6, 2015, comes five years after the Biologics Price Competition and Innovation Act of 2009 was passed as part of the Affordable Care Act, which was signed into law in 2010. And it comes nearly a decade after the first biosimilar product was approved in Europe.
Yet despite this year’s developments, the economics of who benefits most in the commercialization of biosimilars is still a chief concern, starting with the manufacturer. “I think at the point in which a company decides to make a biosimilar, it has to say ‘what is important to me by way of the indications? Who’s going to buy it? Who’s going to pay for it? For this particular product, what patients are going to benefit? And who’s going to make the decisions on behalf of those patients?’ And they simply have to build that into part of their strategy pre-approval,” said Woolett.
One prospective ally would appear to be government, payers, including Medicaid. The high cost of new biologic medicines threatens to send U.S. healthcare costs soaring. Yet, managed care has already demonstrated its ability to reduce these costs. Senior Analyst Aaron (Ronny) Gal, PhD, of Sanford C. Bernstein and Co. told attendees that the entire healthcare community owed Express Scripts a debt of thanks. “Express Scripts got into the hep C (hepatitis C) market and forced prices down for drugs from $100-thousand to $60-thousand and did everyone a favor,” he said.
However, each product in each therapeutic category presents a unique market dynamic, making it difficult to generalize. “I think it’s a very complex marketplace and different people are going to be astute on different aspects. So I think it’s at the business model (level),” said Woollett.
“We have the brand model: You start with low volume, you build over time, and it’s detailing and marketing that makes the difference. And then you historically have had the generic model where you compete purely on price and you automatically substitute it,” she said. “I think we have a new model of some combination in the middle where there’s a level of detailing and marketing, but you also have to be acutely sensitive to price, and that includes what it costs you to get to market in the first place.”
Last updated: 6/12/15; 10:40am EST