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 South Korean-based company, Alteogen Inc.
Established in 2008, Alteogen is focused on the development of bio-betters, with an emphasis on increased half-lives. It is a fairly new player in the biosimilar field, however, and has partnered with Chinese, Japanese, and Brazilian companies to advance the development of at least two biosimilars.
Why you may be hearing more about this company: Its lead product, a biosimilar of aflibercept (originator product Eylea®) for the treatment of macular degeneration, has just completed preclinical testing. They have announced their intention to file this year with the US Food and Drug Administration to begin the clinical trial process of ALT-L9. Additionally, Alteogen is beginning the drug characterization process for a version of trastuzumab.
Whereas both agents are several years away from potential marketing, Alteogen believes that ALT-L9 may demonstrate some distinct advantages over Regeneron’s originator product. The manufacturer believes that potential benefits include better storage and transport characteristics, including longer dates to expiration and resistance to high temperatures. The company points to proprietary technology which may help it to achieve this “bio-better” status in the biosimilar space with trastuzumab. Its website says that using “an antibody drug conjugate technology conjugating the anti-cancer chemical drugs to an antibody protein… is a technology for the next generation anti-cancer therapeutics, which increase the effectiveness and reduces side effects of the anti-cancer cells directly.” It has applied this technology to trastuzumab, and this agent (ALT-02) has completed a phase 1 trial.