The Arthritis Advisory Committee will meet on March 17 to decide whether to recommend a version of Janssen’s monoclonal antibody Remicade (infliximab) after the biosimilar was submitted to the US Food and Drug Administration (FDA) last year by Korean drugmaker Celltrion and its partner Hospira.
“Even though Celltrion is doing the filing, if approved by the FDA, Hospira will assume responsibility for sales of the medication in the US,” Hospira spokesperson Julie Ferguson told Biopharma-Reporter.com.
“We submitted a BLA filing on August 8, 2014 for CT-P13/biosimilar infliximab. Together we look forward to continuing our work with the FDA on the approval pathway for biosimilar infliximab, which will be reviewed by an FDA Advisory Committee in March.”
The two firms are co-developing eight mAb biosimilars, though the future of the collaboration will depend on Pfizer which, after announcing it had entered a definitive agreement to buy Hospira for $17bn last week, said it would be sitting down with Celltrion to discuss how the partnership fits in with Pfizer’s own biosimilar pipeline.
“Having seen firsthand the positive impact of biosimilars in other countries during the past seven years, we look forward to this Advisory Committee, and other future milestones, as we lead a new era of bringing more affordable biologic medicines to patients in the US,” Ferguson said.
The March meeting will be the second to assess a biosimilar in the US. In January, the FDA recommended Zarxio, a version of Amgen’s Neupogen (filgastrim), which was described by its manufacturer Sandoz as bringing the US “one step closer to delivering high-quality biosimilars to patients.”
However, some commentators have predicted more complex molecules like mAbs could face a tougher time achieving approval than the “relatively low-risk product” Zarxio which has been available in Europe since 2009 under the name Zarzio.
INN debate
The US is playing catch-up with Europe, as Celltrion/ Hospira’s biosimilars were approved by the EMA in July 2013 under the names Remsima and Inflectra, respectively, and Ferguson said if the FDA approves the product, it should do so with the same “trade name Inflectra, and with the same International Nonproprietary Name (INN) – infliximab - as the reference product.
“This has been our experience in other regulated markets to date and leads to greater patient safety and less healthcare provider confusion.”
Hospira has echoed others, including Novartis, Mylan and the Generic Pharmaceutical Association (GPhA), by openly calling for biosimilars, once approved in the US, to share the same INN, while industry bodies such as BIO and PhRMA, plus proprietary biologic makers AbbVie and Genentech, have argued biosimilars should be uniquely named.