Celltrion to Begin Phase 1 Trial for Denosumab Biosimilar

Incheon, Republic of Korea—based Celltrion Healthcare said it is beginning a phase 1 clinical trial for its denosumab biosimilar (CT-P41) in September, according to company officials in a press release.

The product, referencing Amgen’s Prolia, is a monoclonal antibody injection that targets receptor activator of nuclear factor kappa-Β ligand (RANKL) proteins in patients with osteoporosis.

According to Amgen’s annual earnings report, Prolia sales increased by 17% for a total of $2.7 billion in 2019.

Celltrion said it plans to begin phase 3 clinicals trials for CT-P41 in the first half of 2021 and plans to commercialize it in February 2025, which is when Amgen’s patents for Prolia expire in the United States.

"We plan to successfully launch the CT-P41 clinical trial to provide high-quality biosimilar products at reasonable prices and introduce our products early in the big global markets such as the United States and Europe," said company officials.

Celltrion’s Other Biosimilars

Celltrion said it expects CT-P41 to become a future growth driver in addition to the company’s other biosimilars including CT-P17, which references Humira (adalimumab); CT-P16, that references Avastin (bevacizumab); CT-P39, which references Xolair (omalizumab); and CT-P43, that references Stelara (uztekinumab).

Celltrion applied for European commercialization approval for CT-P17 in March for all Humira indications including rheumatoid arthritis, ulcerative colitis, and psoriasis.

The company plans to conduct a phase 3 trial for CT-P16 in the first half of 2021 for the treatment of metastatic colorectal cancer, metastatic breast cancer and non—small cell lung cancer, according to Byoungseo Choi, head of marketing at Celltrion, in an interview with The Center for Biosimilars^®.

Choi said that CT-P39, which treats asthma and chronic idiopathic urticaria, is currently being tested in a phase 1 trial and is scheduled to begin phase 3 trials in 2022.

CT-P43 is scheduled to begin phase 1 trials later this year for the treatment of plaque psoriasis and psoriatic arthritis, according to Celltrion.

"We have developed CT-P41, an osteoporosis drug, to expand our product portfolio with autoimmune disease drugs and anti-cancer-focused biopharmaceuticals including Remsima, Truxima, and Herzuma,” said Celltrion company officials.

Remsima (infliximab) was approved for marketing in Europe in 2013 and in the United States in 2016. Celltrion’s subcutaneous version, Remsima SC, received FDA approval in 2019 and recently was granted marketing authorization by the European Commission.

Remsima was chosen to be part of the CATALYST trial, which is assessing the effectiveness of the biosimilar in treating patients hospitalized with coronavirus disease 2019 (COVID-19) in June.

This week, Celltrion announced a partnership with Intract Pharma to develop the world’s first oral infliximab for the treatment of inflammatory diseases such as rheumatoid arthritis.

Earlier this year, the World Health Organization gave prequalification status to Truxima (rituximab) and Herzuma (trastuzumab), which is intended to increase physician confidence in prescribing oncology biosimilars.

Truxima was the first rituximab biosimilar in the United States, where it launched in November 2019, and was approved in Europe in February 2017. Herzuma launched in the United States in March 2020 and received European marketing authorization in February 2018.