Don’t bad mouth biosimilars—they are needed to help hold down skyrocketing drug costs.
That’s the message from a group of 19 institutional investors—representing $430 million in assets—that is asking 25 pharma and biotech companies to agree to a set of business principles to guide corporate boards on policy and oversight responsibilities related to biosimilar activities.
According to the principles outlined in the group’s Investor Statement on Board Oversight of Biosimilar Issues, sent recently to each company, recent actions by some sponsors could limit the acceptance of biosimilars, which would affect any projected savings and undermine widespread biosimilar use.
The group’s concern stems from some sponsors’ request that the FDA go beyond determining if a biosimilar is safe for substitution over the branded biologic, and give biosimilars different nonproprietary names so side effects can more easily be tracked. The group of investors opposes new product naming, saying it would communicate to providers and insurers that the lower-priced biosimilars are less effective, which in turn would limit prescriptions and the ability of pharmacists to dispense them. This is in sharp contrast to generics drugs, which are considered equal to brand name pharmaceuticals and whose safety and side effects rarely are questioned.
“The goal of our statement is to make sure there is unfettered access to, frankly, cheaper treatments, and eliminating artificial barriers such as putting patient safety first as a smoke screen for not wanting competition in this space,” said Lauren Compere, managing director at Boston Common Asset Management, one of the 19 institutional investors.
The "name game" also has prompted a small group of U.S. Senators to ask the FDA to issue its own policy. Recently, several patient groups asked the FDA to issue different names for biologics and biosimilars.
Compere said the investor group also opposes state legislation introduced in 18 states that imposes limits on pharmacists’ ability to prescribe lower-priced biosimilars. The bills, which include additional record keeping and communications requirements, have failed to gain legislative support in 11 of those states.
So far only two proposed biosimilars have been submitted to the FDA for approval. By contrast, in Europe regulators have approved 14 biosimilars since 2006, with which no immunogenicity issues have arisen.
“In our view, by engaging in activities that signal broad patient safety concerns about biosimilars and the capabilities of the FDA to protect against these risks, companies create market uncertainty, dampen competition and misconstrue the biosimilar safety record in Europe and other markets,” the investor group wrote in its statement sent to 25 sponsors.
The investors also want boards of directors at the 25 companies to disclose information about any lobbying efforts or business deals that would hinder the availability of biosimilars.
“As long-term investors, we are very pleased that the companies support the principles,” said Meredith Miller, chief corporate governance officer at the United Auto Workers (UAW) Retiree Medical Benefits Trust, who leads the investor group and developed the statement of principles. “Corporate behavior that encourages innovation, transparency, patient safety and access is the financial engine of the healthcare sector.”
The majority of the 19 investors in the group are organizations involved with labor groups, unions, retirement, asset management and healthcare organizations concerned about high drug prices and the future of biosimilars as low-cost alternatives. They include the AFL-CIO Office of Investment, AFT Retirement Plan & Trust, Massachusetts Laborers Benefit Funds, Dominican Sisters of Hope, Illinois State Board of Investment, New York Common Retirement Fund, Trillium Asset Management and the Northwest Coalition for Responsible Investment.