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Eye on Pharma: Alteogen to File IND for Proposed Aflibercept Biosimilar
Drug maker Alteogen has announced that it will file an Investigational New Drug (IND) application with the FDA for its proposed biosimilar aflibercept (ALT-L9), an anti–vascular endothelial growth factor therapy referencing Regeneron’s Eylea, during 2018.
Drug maker Alteogen has announced that it will file an Investigational New Drug (IND) application with the FDA for its proposed biosimilar aflibercept (ALT-L9), an anti—vascular endothelial growth factor therapy referencing Regeneron’s Eylea, during 2018.
According to The Investor, Alteogen, based in the Republic of Korea, has completed US-based preclinical studies of ALT-L9 that demonstrated that the proposed biosimilar is similar to the reference, and says that it will present official preclinical data within the next 3 months. The preclinical toxicity study was conducted in animals during a 13-week period. Pulse News reports that the biosimilar developer will initiate global clinical trials soon after it receives an official report on the animal test results.
“We plan to present the official analysis report of the preclinical results at an academic conference and expect licensing-out negotiations to be accelerated,” Alteogen CEO, Soon-Jae Park, said in a statement.
According to Alteogen, ALT-L9 is also more resilient to high temperatures, and has a longer shelf life, than the originator drug because of the biosimilar developer’s formulation technology.
The 1 additional biosimilar in Alteogen’s pipeline is a proposed trastuzumab molecule, ALT-02. The drug reportedly underwent phase 1 studies in Canada in 2016, and phase 3 clinical trials for the drug were slated to begin in 2017. The drug maker also reports that it is developing a so-called “biobetter” (a therapy that has resulted from intentionally altering a biologic product in order to improve its clinical effects) of a monoclonal antibody using the company’s proprietary antibody-drug conjugate technology.
Alteogen is not the first biosimilar developer to announce progress on an aflibercept product during this month; Momenta Pharmaceuticals and its partner Mylan announced on January 3 that they will initiate a pivotal clinical trial of M710, in 2018. On January 8, biosimilar developer Coherus announced at the 36th Annual J.P. Morgan Healthcare Conference that its CHS-2020 has initiated preclinical development.
Resolution of Injection Site Reactions After Switching to Adalimumab Biosimilar
February 22nd 2025A 15-year-old girl with ulcerative colitis who developed injection site reactions to the adalimumab reference product was successfully switched to the biosimilar LBAL without recurrence of symptoms, demonstrating the safety and effectiveness of switching for medical reasons, likely due to an allergic reaction to an excipient in the originator.
Biosimilars in Action: Market Shifts, Legal Insights, and FDA Approvals
February 9th 2025In this episode of Not So Different, host Skylar Jeremias covers the latest biosimilar developments, including new FDA approvals, patent disputes, and biosimilar market trends shaping the health care landscape.
FDA, EMA Approve Second Pair of Denosumab Biosimilars
February 17th 2025The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis' denosumab biosimilars, which will be marketed under different names depending on whether they will be used to treat osteoporosis or bone metastases.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
