Categories & Search

Category: Labeling

FDA Issues Final Guidance on Biosimilar Labeling, Sticking with Generic Model

Earlier this month, FDA issued final guidance on the labeling of biosimilar products. The final guidance continues the approach adopted in FDA’s March 2016 draft guidance. That approach largely treats biosimilars like generic drugs for purposes of labeling, even though biosimilars, unlike generic drugs, are not exact copies of innovator products.

Categories: , , ,
Go

First Decision on Label Carve-Outs for Biosimilars Expected in Enbrel Litigation

As biosimilar litigation between Amgen, the maker of Enbrel® (etanercept), and Sandoz, the maker of biosimilar ErelziTM (etanercept-szzs) heads toward trial before Judge Claire Cecchi in the District of New Jersey, Sandoz is seeking to stave off Amgen’s infringement claims for three of the patents in suit by pointing to its recent amendment to the Erelzi label, which “carves out” certain treatment indications listed on the Enbrel reference label and, Sandoz argues, moots any claim that Erelzi infringes Amgen’s patents covering the use of etanercept to treat those conditions.

Categories: , , , ,
Go

Part III: Stakeholder Comments on FDA’s Interchangeability Guidance for Biosimilars

This post, Part III, of a three-part series (Part I and Part II) on FDA’s interchangeability draft guidance highlights a number of open issues that stakeholders have identified in their comments to FDA.  These include the naming and labeling for interchangeable products as well as the relationship between multiple interchangeable products for the same reference product.  Biosimilar makers also wanted FDA to make clear that physician-mediated switching is possible for non-interchangeable biosimilar products even if pharmacy-level substitution is not.  A number of patient groups, by contrast, expressed concern that payers were in effect mandating pharmacy-level substitution for non-interchangeable biosimilars by taking innovator products off formularies.

    Categories: , , , , , ,
    Go

    FDA Announces Approval of Second U.S. Biosimilar

    On April 5, the FDA announced the approval of Inflectra, Celltrion and Pfizer’s biosimilar of Johnson & Johnson’s Remicade (infliximab).  Inflectra is now the second biosimilar approved for sale in the United States, after Sandoz’s Zarxio. Inflectra’s label and naming reflect the latest FDA guidance.

    Categories: , , , ,
    Go

    Update on FDA’s Approach to Labeling Biosimilars Like Generics

    The FDA approved label for the first U.S. biosimilar, Sandoz’s Zarxio, has raised concerns.  Zarxio was launched on September 3, 2015 with a label that does not state that the product was approved as a biosimilar to Amgen’s Neupogen and that it has not been determined to be interchangeable to Neupogen.  Instead, Zarxio’s label is nearly identical to that of Amgen’s Neupogen and does not identify the information provided by Sandoz to FDA to obtain Zarxio’s approval, including information on immunogenicity specific to Zarxio. AbbVie has supplemented its citizen petition urging FDA not to allow biosimilars to be labeled like generic drugs since biosimilars, unlike generic drugs, are not identical to the originator product and requesting distinct labeling for biosimilars.  In briefing U.S. senators on September 17, FDA promised to issue guidance on labeling of biosimilars.  

    Categories: , , ,
    Go

    FDA Approach to Labeling Treats Biosimilars Like Generics

    A recent FDA guidance document eliminated biosimilar labeling information that FDA previously viewed as “necessary” for physicians to make prescribing decisions, including whether the biologic is biosimilar to or interchangeable with the reference product.  The FDA also approved a label for the first approved US biosimilar that omits this information.  The FDA’s actions have drawn criticism from associations of physicians who routinely prescribe biologic medicines and the innovator companies that develop them.

    Categories: , , ,
    Go