Companies Clinch Deals for Global Biosimilar Commercialization

In a single week, Prestige Biopharma and Intas Pharmaceuticals plus Hikma Pharmaceuticals and Celltrion Healthcare entered into commercialization agreements for a bevacizumab biosimilar and an adalimumab biosimilar, respectively.

The deal between Prestige and Intas applies to the commercialization of Prestige’s biosimilar (HD204) referencing Avastin (bevacizumab) for the United States, Europe, Canada, countries in the Middle East and North Africa (MENA), Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan, and Tajikistan.

“We are delighted to establish a partnership with Intas for the key markets, the United States and Europe. Accord is the ideal partner to commercialize our bevacizumab biosimilar in these territories. With this collaboration, we look forward to further strengthening the value of our biosimilar programs in global markets,” said Lisa S. Park, PhD, CEO of Prestige Biopharma, in a company statement.

Bevacizumab products treat patients with metastatic colorectal cancer, advanced non–small cell lung cancer, advanced kidney cancer, certain epithelial cancers, and cervical cancer.

According to Prestige, HD204 is being tested in the phase 3 SAMSON-II trial, which will compare the safety and efficacy profiles of the biosimilar with Avastin. Previously, positive results were found in the phase 1 SAMSON-I pharmacokinetic study. Prestige said that its anticipates the 2023 filing of applications with regulatory authorities in the United States and the European Union.

Under the agreement, Intas and its affiliate Accord Healthcare will be responsible for the commercialization of HD204 in the aforementioned countries and Prestige will be in charge of development and distribution.

“We are pleased to announce the collaboration with Prestige Biopharma. This collaboration is in line with our long-term strategy and reinforces our commitment to improving access to high-quality biosimilar drugs for cancer patients globally,” Binish Chudgar, MBA, vice chairman and managing director of Intas Pharmaceuticals, commented.

Under the agreement between Hikma Pharmaceuticals and Celltrion Healthcare, Yuflyma (CT-P17), a biosimilar referencing Humira (adalimumab), will be commercialized by Hikma in MENA countries. The deal builds on the existing partnership between the 2 companies. In the past, Hikma had launched 3 of Celltrion’s biosimilars: Truxima (rituximab), Remsima (infliximab), and Herzuma (trastuzumab). Hikma is also working to launch Remsima SC, Celltrion’s biobetter of Remsima that allows for subcutaneous administration of infliximab.

“Building a portfolio of high-value, differentiated products continues to be a key focus area for Hikma…. Celltrion’s strong technical capabilities and our well-established commercial presence continues to help us increase patients’ access to important medicines that help them in their treatment journey for these difficult diseases. This agreement builds on our position as the fourth largest supplier of medicines in MENA and furthers our purpose of putting better health within reach, every day,” said Mazen Darwazah, executive vice chairman and president of MENA at Hikma, in a statement from the company.

Yuflyma is used for the treatment of several rheumatic conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, axial spondyloarthritis, psoriatic arthritis, psoriasis, plaque psoriasis, hidradenitis suppurativa, Crohn disease, ulcerative colitis, and uveitis.