Safe Biologics

All biologic drugs, including biosimilars, should be required to have unique names to ensure their safety, the Alliance for Safe Biologic Medicines (ASBM) said Sept. 13.

ASBM released a survey examining physician practices and perspectives with regard to biosimilar medicine identification and substitution. ASBM said these policy issues remain unresolved and will have “a fundamental impact on patient safety.”

The 2010 health care reform law contains an abbreviated Food and Drug Administration approval pathway for generic biologic drugs, also called biosimilars. In February, FDA issued three draft guidance documents on biosimilar product development, focusing on scientific and quality considerations in demonstrating biosimilarity of a proposed product but giving little guidance on how these products should be named (10 PLIR 173, 2/10/12).

Survey Results
Sixty-four percent of the 350 physicians surveyed assume if products have the same name, a patient can be safely switched from one product to another during treatment, and more than 76 percent view products with the same scientific name as structurally identical, the survey said.
ASBM said inappropriate substitution is a major risk if different biologics have the same scientific name.

The vast majority (99 percent) of surveyed physicians refer to biologic medicines by name for both recording in charts and for reporting adverse events, according to the survey. Additionally, less than 1 percent of surveyed prescribers use national drug code numbers for records or reporting.

Physicians also are concerned about a patient being switched from one biologic drug to another, ASBM said. Eighty-five percent of responding physicians want the authority to designate a biologic medicine as “dispensed as written,” just as they have for chemical products. Additionally, 86 percent want to be notified before a patient is switched to a biologic other than the one prescribed even if there are no known concerns associated with the product.

“We have been very supportive of the FDA’s efforts to create a pathway that ensures biosimilars are safe and effective for patients,” Richard O. Dolinar, chairman of ASBM, said in a statement. “This survey demonstrates the potential safety consequences of giving different biologic products the same scientific name. In order to avoid inappropriate substitution, all biologics should be required to have distinct names.”

Unique Names Needed
Dolinar told BNA Aug. 20 in an interview that unique names are needed to be able to differentiate between the drugs. He said if unique names are not used and a patient experiences an adverse event, it would not be possible to determine what drug caused the adverse event. “It’s a safety issue,” Dolinar said.

“The first rule of medicine is to do no harm.” Dolinar said. “When doctors write orders they are meant to be followed exactly” and “in order to be precise you need unique names.”

“Physicians are concerned about the confusion caused by not having unique names,” Michael Reilly, executive director of ASBM, told BNA.

As the debate about unique names continues, stakeholders await more guidance from the agency.

Dolinar said he expects that FDA will come out with more guidance on biosimilar naming. Dolinar said the agency is “moving cautiously and asking for opinions” from different stakeholders on this issue.

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

The Pharmaceutical Research and Manufacturers of America (PhRMA) agrees that biosimilars need unique names. In comments submitted to FDA in May, PhRMA said “unique non-proprietary names are an essential feature of a robust system for adequately tracking adverse events.”

PhRMA said “it is critical to establish unique non-proprietary names for each biosimilar and biological product at the time of market entry regardless of the possibility of the biosimilar later seeking approval as an interchangeable biological product.”

Specifically, PhRMA said it supports a naming system that uses a common stem with a unique suffix. PhRMA suggested FDA consider a system like the one used in Japan, where biosimilar products in the same class share a common name plus a designation that it is a biosimilar plus a unique number that has been assigned to the biosimilar.

Generic Industry’s Perspective
In comments submitted to FDA in April on the draft guidances, the Generic Pharmaceutical Association said that biosimilars should be able to be tracked if there is a safety issue, but using unique individual nonproprietary names (INNs) would create safety problems.

GPhA said INNs “help inform health care providers as to the active ingredient in medicines, including biologics, and will help prevent double-dosing in the case of biosimilars IF the biosimilar shares the INN with its reference product.”

The generic industry group said that using different INNs for biosimilars “would create unique safety problems as physicians and other health care providers have every reason to expect that products that share active ingredients will share INNs, and so different INNs mean different active ingredients.”

GPhA said current systems in the United States do not require a unique INN “for effective track and trace of products” and “much of the track and trace of products is related to the reimbursement system and relies on the NDC number.” NDC stands for National Drug Code.

Pharmacy Groups Weigh In
In May, the American Pharmacists Association (APhA), the National Association of Chain Drug Stores (NACDS), and the National Community Pharmacists Association (NCPA) sent a letter to FDA on the draft biosimilar guidances (10 PLIR 747, 6/8/12). In the letter, the groups said biosimilars should have the same name as their reference biologic products.

“We are concerned that mandating the use of unique individual nonproprietary names (INNs) could create the very public health issues that the FDA wishes to avoid: therapeutic duplication and general confusion relative to the appropriate use, safety and efficacy of biologic products.”

The groups said the use of unique names “would increase the burden of being able to distinguish which products are biosimilar and interchangeable with which reference drug and may pose difficulties in recognizing the best alternative drug for therapeutic use in a timely manner.”

Additionally, the groups said using unique INNs would be contrary to the World Health Organization (WHO) naming system for drugs, which could cause confusion in the global marketplace.

“We acknowledge that the ability to uniquely identify which biological product a patient is taking is important, especially in cases of adverse events and quality issues,” the pharmacy groups said. “However, the use of INNs is not a warranted solution and may interfere with current pharmacy safety alert systems and complicate the collection of global safety information.”

The groups said a different unique identifier, such as an NDC code, could be used, which would allow pharmacies to track the specific drug that a patient is prescribed.

–Bronwyn Mixter

For More Information
The survey.
GPhA’s letter and the APhA, NACDS, NCPA letter.

Reproduced with permission from Pharmaceutical Law & Industry Report, 10 PLIR (Sept. 21, 2012). Copyright 2012 by The Bureau of National Affairs, Inc. (800-372-1033) <http://www.bna.com>