Celltrion Announces Simultaneous Phase 1, Phase 3 Trials for Adalimumab Biosimilar

Korean drug maker Celltrion has announced that it ready to begin phase 1 and phase 3 clinical trials for CT-P17, a proposed adalimumab biosimilar referencing AbbVie’s Humira, which is used to treat a variety inflammatory diseases. The trials will be conducted simultaneously at 75 sites in 8 nations in the European region including the United Kingdom, and the company indicates that the trials will be completed by 2020.

According to the biosimilar developer, the proposed product contains a higher-concentration formulation of adalimumab than other biosimilars that are currently approved, a fact that Celltrion hopes will differentiate its product from competitive biosimilars.

Novel formulations of biosimilars are becoming a hallmark of Celltrion’s approach; recently, the company announced that a new formulation of its infliximab biosimilar (sold as Inflectra in the United States and as Remsima in the European Union) that is intended for subcutaneous rather than intravenous administration has comparable efficacy and safety to the currently authorized product in patients with Crohn disease and rheumatoid arthritis.

Click here to read more about subcutaneous Inflectra.

If eventually approved, Celltrion’s product will compete with a growing field of biosimilars referencing the blockbuster Humira; already approved for marketing in the European Union are Amgen’s Amgevita (a molecule also authorized under the brand name Solymbic), Boehringer Ingelheim’s Cyltezo, Samsung Bioepis’ Imraldi, and Sandoz’s Hyrimoz.

The first biosimilar adalimumab products, Imraldi and Amgevita, are expected to launch in the European Union in October 2018, and national health systems, including the United Kingdom’s NHS, are already preparing to begin using the products.

In the United States, the FDA has approved 2 biosimilar adalimumab products (Cyltezo and Amgen’s Amjevita, which is given a slightly altered spelling for the US market), but no biosimilar adalimumab is set to launch prior to 2023 as a result of legal settlements concerning AbbVie’s patents on the reference product.

Celltrion also reports that its pipeline contains biosimilar candidates of bevacizumab, etanercept, cetuximab, and palivizumab, as well as innovator antibodies targeting influenza, breast cancer, hepatitis B, and rabies.