On occasion, we profile some biosimilar manufacturers about whom our readers may not be familiar. This generally refers to companies that have products that are in earlier-stage research or those who simply have not been in the news as often as their colleagues. In this post, we highlight a joint venture between AstraZeneca and Samsung BioLogics, Archigen Biotech Ltd.
Established in 2014, Archigen has focused on the development of a single biosimilar drug, SAIT101, which will compete in the rituximab space against the likes of Rituxan® and MabThera® (and perhaps other approved rituximab biosimilars). According to a 2016 report, Samsung Electronics had initially sought to develop this agent in 2012, but abandoned the effort soon afterward because of lack of capital.
One of the partners, Samsung BioLogics, also has a stake in Samsung Bioepis (with Biogen). Archigen says on its website that it will be relying on “leading global Contract Research Organizations and Contract Manufacturing Organizations to ensure efficient execution of drug development activities.”
Why you may be hearing more about this company: Its phase 1 study of SAIT101 was implemented October 2016, and clinical results should be available soon. This study was conducted with 246 patients with rheumatoid arthritis, testing the drug against both reference drugs, and included a switching arm. This is unusual for both the size and extent of a phase 1 investigation. Additionally, the organization did not conduct a separate drug trial in healthy volunteers, which is often a first step in analyzing the medication’s pharmacokinetics and pharmacodynamics. Instead, Archigen is moving directly to a phase 3 trial in patients with follicular lymphoma. This study started in January 2017, with initial results expected in May 2019. The phase 3 trial will have over 300 patients, and use MabThera as the comparator.
Based on these dates, a 351(k) filing could be achieved as early as the fourth quarter of 2019, with potential approval in the third quarter of 2020.
Archigen Biotech has not posted on its website any information about subsequent drug targets. Indeed, its website is sparse. It is possible that following the clinical development of SAIT101, Archigen will be more focused on new branded agents, leaving Samsung Bioepis to work on its biosimilar portfolio.