The FDA approved Valeant’s new biologic brodalumab (Siliq) on February 15, 2017, for the treatment of moderate to severe plaque psoriasis, but did not follow the agency’s own finalized guidance on naming new and previously approved biologics and biosimilars with a 4-letter suffix “devoid of meaning” to be attached at the end of the nonproprietary name. For example, Amgen’s filgrastim (Neupogen) is to be changed to filgrastim-jcwp.
Siliq, a monoclonal antibody, is the first novel biologic to be approved since the January 12, 2017, release of the FDA’s finalized guidance on nonproprietary naming of biologic products. The guidance explains that the suffixes are needed to create a distinguishable naming element for biologics and biosimilars in order to facilitate pharmacovigilance and accurate identification by prescribers and patients, and to help decrease unintentional substitution of products not deemed interchangeable.1
It was thought that the approval of Siliq might be the first novel biologic approved with the suffix because the FDA guidance had been finalized a month earlier than the drug’s approval. However, Siliq was approved without a suffix because the final guidance was issued at a point in the review of the drug’s application that the FDA said did not allow enough time for the agency to designate a proper name that includes a suffix as described in the guidance.1 In the interest of public health, the FDA did not want to delay the approval of Siliq in order to license the product with a designated proper name, according to an agency spokesman, and therefore issued the approval with only the designated proper name and no suffix. However, the FDA clarified that it intends to work with Valeant to implement the naming convention described in the final guidance for Siliq.1
The FDA may also be waiting for an approval from the Office of Management and Budget (OMB) approval of the information collected under the final guidance before implementing the suffix requirement on novel products.1 Some stakeholders have asked the OMB to block the implementation of the naming guidance because the FDA ignored the costs of implementing the new naming system. The naming guidance, including the post-marketing changes of names to comply with the guidance, has met with criticism from drug sponsors including Novartis and AbbVie, which said the naming convention would not support safe prescribing and pharmacovigiliance. The American Society of Health-System Pharmacists also spoke against the plan as burdensome for every segment of healthcare, including hospitals, payers, and providers, and CVS Health said the FDA’s guidance could have a potentially deleterious effect on the marketplace and a chilling effect on the development of affordable and accessible biosimilars.
1. Cipriano M. Where’s the suffix? Valeant’s Siliq approved without four-letter identifier. Pink Sheet. February 16, 2017.