Safe Biologics

On March 14, Dr. Dolinar gave a presentation on a “Clinicians’ Perspective on Biosimilars” at the Biosimilar Insulins Impact on Clinical Practice Publications Roundtable Meetings in Dallas.

View his presentation here.

ASBM Executive Director Michael Reilly was quoted in a BNA article on biosimilar state legislation.

Reproduced with permission from Pharmaceutical Law & Industry Report,11 PLIR 286 (March 1, 2013). Copyright 2013 by The Bureau of National Affairs, Inc. (800-372-1033) <http://www.bna.com>

(BNA) — Will State Laws Thwart Use of Biosimilars?

Major Development: Several states are considering legislation that would require physician notification when a patient is switched from a branded biologic to an interchangeable biosimilar.

Brand, Generic Positions: Amgen, Genentech, and their allies are pushing for the state legislation. Meanwhile, generic companies say the state legislation is a “preemptive strike” by branded drug companies to limit access to these products.

Branded drug companies are pushing for state legislation that would place certain restrictions on biosimilars, while generic drug companies and pharmacy benefit managers say these proposals would limit patient access to these drugs and make them more expensive.

The 2010 health care reform law, through its Biologics Price Competition and Innovation Act (BPCIA), created a pathway for the Food and Drug Administration to approve follow-on biologic drugs, or biosimilars, but the agency still is working on implementation. The agency issued three draft guidances on biosimilars in 2012 (10 PLIR 173, 2/10/12) and has yet to issue guidance on the issue of interchangeability.

Brand biologic companies, including Amgen and Genentech, are pushing for state legislation on biosimilars that would require a physician to be notified when a pharmacist switches a patient from a brand biologic to an interchangeable biosimilar. Meanwhile, generic companies say state legislation should wait until after FDA is finished implementing the pathway so that legislation does not end up restricting access to these drugs.

According to the Generic Pharmaceutical Association (GPhA), bills are or have been under consideration in Arizona, Arkansas, Colorado, Florida, Indiana, Maryland, Massachusetts, Mississippi, North Dakota, Oregon, Pennsylvania, Texas, Virginia, and Washington.

Branded Company Campaign
Amgen Inc. said in a statement Jan. 25 that it is “helping to educate state policymakers” on biosimilars “to ensure that physicians, patients, and pharmacists share important information about biologic substitution.”

Amgen said physicians should be notified when a brand biologic is substituted with an interchangeable biosimilar. The company said it believes that a “notification process that does not impose an undue burden on the pharmacist is in the patient’s best interest.” The company said physician notification would “close the gap in biologic traceability that could otherwise be created.”

“Amgen endorses state policies that would put patients first and, in doing so, increase confidence in the biosimilar pathway. It is important to have consistent policies in place at the federal and state level,” Scott Foraker, vice president and general manager of biosimilars at Amgen, said.

Amgen said state efforts to create safe substitution rules for interchangeable biologics will help accelerate the successful implementation of the U.S. biosimilars pathway.

Biologic medicines are different from traditional chemical drugs in several important ways, Amgen said. Biologics are so complex that they usually can only be made by a living cell. In fact, when made by different manufacturers, they differ from each other, the company said.

Biosimilars also have very large molecules compared to chemical drugs and can be more sensitive to storage and handling, Amgen said. As a result, biologic medicines have the potential to cause an unwanted immune response, which can show up months after taking the medicine, the company said.

Amgen said it believes state pharmacy laws must enhance safety monitoring of substituted biologics.

Interchangeability
Michael Reilly, executive director of the Alliance for Safe Biologic Medicines (ASBM), told BNA that the states are moving forward with biosimilars legislation as a way to address both interchangeable and noninterchangeable biosimilars.

ASBM is composed of diverse health care groups and individuals working to ensure patient safety, according to its website. Members of the alliance include Amgen and Genentech.

Reilly said if a state does not have legislation in place, noninterchangeable biosimilars could be substituted for brand products.

“If you look to Europe as a model,” they do not have automatic substitution or interchangeability and they encourage physicians to begin patients on biosimilars rather than on a brand biologic so that patients are not at risk from switching from the brand to the biosimilar, Reilly said.

Interchangeable biosimilars do not exist and FDA has not yet established a pathway, Reilly said. “Nobody knows what an interchangeable is,” he said. “This is about when the first biosimilar is approved and how it is treated.”

“There has been a lot of rhetoric around what an interchangeable is, but there is no experience with interchangeability anywhere in the world,” Reilly said.

Opposition for State Legislation
Ralph Neas, president and chief executive officer of GPhA, told BNA that Amgen and Genentech are pushing for state legislation on biosimilars and are “engaged in preemptive strikes to limit access to safe, effective, and affordable biosimilars.”

Neas said if this effort is successful, it would decrease cost savings from these products and “it would have a destructive impact on many Americans,” as well as state budgets.
Amgen and Genentech are “raising questions” about these products and undermining trust in these new products, Neas said. These companies are “already trying to stack the deck in their favor.”

Neas said FDA still is implementing the biosimilars pathway and states could enact legislation after the pathway is created. He said that when FDA does approve an interchangeable biosimilar, patients and physicians should not have to deal with “roadblocks.”

“The more attention this issue receives, the more likely Genentech and Amgen’s efforts will fail,” Neas said.

“Biosimilars are not new and have been used in dozens of countries,” Neas said. “There are no reports of adverse events” in these countries and “the safety issue has been addressed already.”

“It’s up to FDA and not Amgen and Genentech,” Neas said.

On Feb. 6, GPhA praised Mississippi for voting down a bill that would make it more difficult for consumers to get access to biosimilar medicines. “With nearly $11 million spent in 2011 alone on costly biologic medicines in their state Medicaid program, Mississippi state legislators know that creating barriers between patients and newer, low-cost versions of these therapies is not right for their state,” Neas said in a Feb. 6 statement.

Neas said that “if passed, these measures would be harmful [to] their constituents and wreak havoc on their state budget.”

“Like the American Cancer Society and others, we believe that the time to consider laws on biosimilars is after FDA has laid out a meaningful roadmap for the safety rules for these new medicines,” Neas said. “To do so before those regulations are released is a Trojan Horse: a measure to kill competition in the name of safety.”

FDA Commissioner Margaret A. Hamburg said at GPhA’s annual meeting Feb. 22 that “efforts to undermine trust in these [biosimilar] products is worrisome and represents a disservice to patients who could benefit from these lower cost treatments.”

“The high standard for approval of biosimilar and interchangeable products means that patients and health care professionals can be assured that when those products go to market, they will meet the standards of safety, efficacy, and high quality that everyone expects and can count on,” Hamburg said.

PCMA Weighs In
The Pharmaceutical Care Management Association (PCMA) Jan. 31 said in a statement that the state proposals would increase costs for employers, public health programs, and patients, and restrict access to lower-cost alternatives. PCMA represents pharmacy benefit managers.

PCMA said the campaign by branded biologic manufacturers for these state proposals “is designed to preempt the FDA’s process by creating a flurry of state laws that will conflict with the FDA’s forthcoming national standards.”

“Creating a patchwork of dueling state and federal rules would make it harder for pharmacists to know when they can dispense a biosimilar,” PCMA said. That would raise costs for patients and their employers, who typically cover two-thirds of prescription drug benefit costs, the group said.

Mark Merritt, president and chief executive officer of PCMA, said “campaigning to restrict the use of biosimilars enriches brand manufacturers at the expense of the employers, public health programs, and patients who need access to lower cost medicines.”

The American Cancer Society Cancer Action Network (ACS CAN) said in a January statement that it is not taking a position yet on changing state pharmacy laws pertaining to the interchangeability, substitution, and related biosimilars patient protections until ‘we better understand the many complex regulatory and scientific issues as well as the current state of state pharmacy practice acts.”

ACS CAN said it “is very supportive of the advancement of both biologics and biosimilars because of their enormous potential as effective tools in the fight against cancer and the improvement of the quality of life for patients.”

By Bronwyn Mixter

The above story appeared in: Pharma. Law & Industry Report