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.
The end of 2017 has been bustling with oncology biosimilar news.
On December 20, 2017, the Food and Drug Administration (FDA) accepted Samsung Bioepis’ application for SB3, its biosimilar version of trastuzumab. The drug would be the fourth to undergo evaluation by the FDA, and may pack on the pressure for Mylan and Biocon’s product Ogivri™, which is the only approved biosimilar trastuzumab.
Mylan/Biocon’s biosimilar was approved earlier this month. As a reminder, though, there are no plans to bring their version of trastuzumab to market immediately. Indications are that owing to an agreement with Roche, they may not launch until 2019 (at the earliest). Trastuzumab biosimilar entries by Celltrion and Amgen/Allergan will not receive FDA decisions until the second quarter of next year. It is unclear whether these manufacturers will decide to launch their versions at risk, thus stealing the initiative from Mylan and its partner. In any case, competition should be vigorous when these products launch (which should be within 12 months of the first launch, assuming FDA approvals). At present, the question is open as to whether Samsung will market SB3 if it receives a positive decision sometime in the fourth quarter of 2018.
In related news…A survey of 200 oncologists revealed that their comfort levels with prescribing biosimilars is widespread. Cardinal Health published a report based on the survey on December 20.
Although these result may relate to oncologists’ multiyear experience with Zarxio® (filgrastim), 82% of the oncologists responding to the survey specifically indicated that they would have no qualms about using biosimilars to treat patients with breast cancer in an adjuvant setting or if they had metastatic disease. As indicated above, no biosimilars are currently marketed for this indication. Furthermore, they expect significant cost savings when using biosimilars: Two thirds said that cost savings with biosimilars are either extremely or very important in their prescribing decision. That’s pretty much the point of biosimilars, isn’t it?
On December 1, the team of Mylan and Biocon received their first biosimilar approval in the US, for an agent to compete with Roche’s Herceptin®. The approval decision on this product was delayed 3 months owing to potential issues involving Biocon’s manufacturing facility. However, this marks the first biosimilar approved for trastuzumab, beating entries from Amgen/Allergan and Celltrion to the 351(k) finish line.
Dubbed Ogivri™ (trastuzumab-dkst), the Food and Drug Administration (FDA) approved the biosimilar to treat human epidermal growth factor receptor (HER)–positive (HER+) breast cancer and HER2+ metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma). The FDA’s Oncology Drug Advisory Committee voted unanimously to approve the drug, and it was originally scheduled for a decision in early September.
Scott Gottlieb, MD, the recently installed FDA Commissioner, stated, “The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs. This is especially important when it comes to diseases like cancer that have a high cost burden for patients. We’re committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs.”
Ogivri will carry the same Boxed Warning as Herceptin, regarding increased risks of heart disease (cardiomyopathy), infusions reactions, lung damage (pulmonary toxicity) and harm to a developing fetus (embryo-fetal toxicity).
The launch of the product may be delayed until 2019 or 2020, based on an agreement between Mylan and Roche. This could mean that although Ogivri is first approved, it may not be first launched.