FDA proposal on biotech drugs sparks criticism

FDA proposal on biotech drugs sparks criticism
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(This story originally appeared on The Hill Extra)

An FDA plan to give biotech drugs more distinct names is facing criticism from multiple sides, including some drugmakers and the federal agency in charge of competition.

At issue is guidance that calls for the addition of different suffixes to the names of original brand name biologics — complex drugs made from living materials — and their copies, called biosimilars. 

Because not all biosimilars are interchangeable, the suffixes are intended to differentiate between biological products that have and have not been determined to be fully substitutable by doctors.

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The Federal Trade Commission is not on board with the Food and Drug Administration’s decision to assign different suffixes to the names of biosimilars and their reference biologics, arguing it could hurt the market for cheaper versions.

“We believe this approach could result in a misperception among physicians that biosimilars differ in clinically meaningful ways from their reference biologics’ drug substances,” Tara Koslov, acting director of the FTC’s Office of Policy Planning, said in an email to The Hill Extra. 

“FTC staff remain concerned that this misperception could deter physicians from prescribing biosimilars, thus dampening biosimilar competition.”

Many of the drugs grabbing headlines for eye-popping prices in recent years are biologics. An often-cited example is the hepatitis C drug Sovaldi, which initially came with a $84,000 price tag for a 12-week course of treatment. Prices since then have soared higher.

But several drugmakers raised similar concerns to the FTC, and the World Health Organization has said the naming convention may not align with international naming policies.

Bruce Leicher, general counsel and senior vice president for Momenta Pharmaceuticals, which makes biosimilars, said assigning different suffixes for interchangeable drugs would suggest they are not the same.

But as far as implementation, it’s mostly a data entry issue, requiring companies and providers to ensure the new suffixes are included in health databases and tracking systems.

“It does create confusion," Leicher said, "but our position is we’re not sure it matters much."

Among those backing the FDA guidance are branded drugmakers and some policy experts who argue that it is necessary for biosimilars to be distinguished, because they are not copies in the same way that generics are to their brand competitors. 

Biologics are more complex molecules, monitored by separate legal and regulatory frameworks, and biosimilar copies are held to a higher standard of similarity than simpler generic copies of chemical-based drugs. 

Biosimilars are seen as a potential lever in curbing rising healthcare costs, which are increasing in large part because of biologics. For example, nine out of the 10 drugs that accounted for the most Medicare Part B spending in 2015 were biologics.

Biotech companies often stress that similar and interchangeable are two distinct concepts.

“The majority of biosimilars are not expected to be deemed interchangeable by the FDA, when the majority of generics generally are therapeutically equivalent and substitutable,” said Thomas Felix, medical director of global regulatory affairs and safety at Amgen. 

The distinguishing suffix will be attached with a hyphen to the core name of each biologic product. Biologics and their related biosimilars currently share that nonproprietary name, which is designated by U.S. Adopted Names (USAN) Council.

For example, products sharing the core name “replicamab” may be renamed “replicamab-cznm” and “replicamab-hjxf.”

A biologic by any other name.

Those concerned by the naming guidance say it could impact how providers view and use biosimilars, a still emerging market that is expected to drive down prices for costly biologics.  

Biologics are 22 times more expensive, on average, than traditional medications, the FTC noted in comments to the FDA when it released proposed guidance in 2015. 

Some say the name modifications are unnecessary because of other identifiers used to track pharmaceuticals throughout the supply chain, such as the national drug code (NDC). Those identifiers have been emphasized in recent laws that boost drug labeling and supply tracking requirements.

“Personally I have never fully comprehended the need for a suffix to a nonproprietary name,” said Gillian Woollett, senior vice president at Avalere Health.

But FDA said in its guidance that other product identifiers, like NDC numbers, are not routinely recorded in billing and patient records, undermining the ability to track adverse events by biologic products that share the same proper name.

NDCs are also mostly used in pharmacies, where only a small percentage of biologics are administered, said Felix, a member of the American Medical Informatics Association (AMIA) public policy committee.

Many biologics are administered intravenously or by injection and in doctors' offices or hospital settings. 

Healthcare procedure codes are often used in clinical settings, but the ability to identify different biosimilar manufacturers is not clear at the moment, he said. 

“At this time, the nonproprietary name is typically conveyed in each of these treatment settings,” Amgen's Felix said. “AMIA agrees that the FDA’s new naming approach does effectively prevent inadvertent substitutions, and we have not heard of any other alternative method to achieve this FDA goal.”

International agents.

The FDA’s naming convention might also impact international efforts to harmonize drug names and develop unique identifiers for biologics.

The WHO, which coordinates international health goals within the United Nations’ system, expressed concerns with FDA’s draft guidance and the agency’s intention to modify nonproprietary drug names, which are created by the U.S. Adopted Names (USAN) Council. 

That name in most cases exactly the same as the globally recognized International Nonproprietary Name (INN), which is managed by WHO.

In its earlier comments, WHO said the FDA naming scheme "confers a proprietary claim on a nonproprietary name" and that it "could not be in the interest of nomenclature harmonization."

WHO was less critical of FDA’s final guidance, which was released Jan. 12. Officials said they did not expect their earlier comments to bind the FDA and are satisfied with the agency’s consideration of its input.

As a guidance, it does not have the same authority as regulation or law, but it is unclear whether any other naming format would satisfy FDA's goal with the guidance.

The guidance will be a topic of discussion at the next INN meeting in April, WHO experts said in an email to The Hill Extra.

In addition, WHO is considering a similar proposal, called Biological Qualifiers. Similar to the FDA, the WHO proposal would assign an identifier, devoid of meaning and unique to each product, to improve tracking and safety.

“The outcomes, and subsequent impact, of the FDA naming guidance will be an additional input into this ongoing work,” WHO said.

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