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In a closely watched move, the US Food and Drug Administration late last week released draft guidelines for labeling that should appear on biosimilars. And the directive is likely to give a lift to generic drug makers as they battle their brand-name rivals in this nascent but important market.

The battle over labeling is significant because this information is used by physicians to determine which medicine — the original biologic or the newer biosimilar — to prescribe to patients.

In its so-called draft guidance, the FDA rejected the argument made by brand-name companies that clinical trial data used to prove a drug is a biosimilar should appear on the product labeling. Brand-name companies believe the data should be included in order to distinguish the medicines.


Instead, the agency proposed using the same information found on the brand-name label along with a simple statement indicating the biosimilar is similar. A final decision, however, has not been made while the agency accepts comments from industry and others.

The issue is “a debate with far-reaching implications,” Sanford Bernstein analyst Ronny Gal wrote in an investor note. “The content of the biosimilar label was argued as critical” for how companies position their different medicines. But in its guidance, he explained, the FDA “struck a clear position” for labeling that resembles the requirements found on generic drugs.


Biosimilars are cheaper copies of brand-name biologics that have demonstrated similar safety and effectiveness. These drugs have been available in Europe for some time, but only last year did the FDA approve the first such medicine in the United States, ushering in what is expected to be a bruising contest among drug makers, but also huge potential savings for payers.

These medicines are expected to save an estimated $44 billion in US health care costs over the next decade. Most analysts and payers forecast that biosimilars will cost 10 percent to 30 percent less than brand-name biologics. This helps explains why some brand-name companies are developing biosimilars themselves, but also squabbling with generic drug makers over various issues.

The battle over labeling has been high on the list.

Last June, for instance, AbbVie filed a petition with the FDA to ask the agency to disclose clinical trial data in a bid to provide physicians with a way to compare brand-name medicines with biosimilars. “It is critical that regulators work to ensure patient safety through rigorous review and clear product labeling of biosimilars as these medicines enter the US market,” the drug maker said when it filed its petition. AbbVie sells the Humira rheumatoid arthritis treatment and has been anticipating biosimilar competition.

In a statement, Chip Davis, who heads the Generic Pharmaceutical Association, expressed his pleasure with the FDA draft guidance. “The proposed label contents avoid causing confusion or raising unnecessary questions about the safety and efficacy of biosimilar products,” he said.

We asked AbbVie for comment and will update accordingly. A spokesman for the Pharmaceutical Research and Manufacturers of America told us the trade group for brand-name drugs was still reviewing the draft guidance and would provide its comments directly to the agency.

The PhRMA spokesman noted, however, that the FDA recommended the biosimilar product labeling should make clear that a brand-name biologic company— and not the generic manufacturer — obtained pertinent clinical-trial data . The agency also proposed that biosimilar labeling include information about uses for which a biosimilar may not be approved.

One group supported the view taken by brand-name drugs. The Institute for Patient Access, which describes itself as a physician’s organization, issued a statement saying the draft guidance may leave some doctors and patients “disappointed.” The organization, which receives backing from the drug industry, argued that the source of clinical-trial data is necessary.

Labeling is not the only biosimilars issue over which brand-name and generic drug makers are squaring off.

Brand-name drug makers won a debate over the extent to which the names for biosimilar drugs should be distinct from biologics. The FDA last fall proposed that biosimilar drug names should add a four-letter suffix that differs from the four-letter suffix that should follow a brand-name biologic.

Meanwhile, the Sandoz generic unit of Novartis, recently asked the US Supreme Court to decide when a company that wants to sell a biosimilar medicine must give notice to the manufacturer of the brand-name version about its product launch. At issue is the timeframe in which a brand-name company can determine what, if any, patent challenges can be pursued, which might further delay a biosimilar launch.

  • When is it copycat and when is it cheaper copies …?

    A statement from the article

    “Biosimilars are cheaper copies of brand-name biologics that have demonstrated similar safety and effectiveness. ”

    When generics from Indian companies are mentioned, they are copycat products?

    The one who controls the language controls the argument.

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