Fuji Pharma Gets Marketing Approval for 3 New Biosimilars in Japan, Alvotech Partner

Alvotech, a biotechnology company, has announced that its partner Fuji Pharma has obtained marketing approval for three new biosimilars in Japan. The biosimilars are part of Alvotech's pipeline, which includes monoclonal antibodies for various therapeutic areas such as inflammatory diseases, oncology, and ophthalmology. The company's strategic commercial partnerships provide global reach and leverage expertise in various markets.

Alvotech (NASDAQ: ALVO), a biotechnology company focused on developing and manufacturing biosimilar medicines, has announced that its commercialization partner in Japan, Fuji Pharma Co., Ltd., has received marketing approval for three new biosimilars from the Japanese Ministry of Health, Labor, and Welfare Alvotech gets marketing approval in Japan for three new biosimilars^[1]. The biosimilars approved for the Japanese market are AVT03, a biosimilar to Ranmark (denosumab), AVT05, a biosimilar to Simponi (golimumab), and AVT06, a biosimilar to Eylea (aflibercept).

AVT05 is notable as it is the first golimumab biosimilar to be approved for sale in major markets globally Alvotech gets marketing approval in Japan for three new biosimilars^[1]. This approval marks a significant milestone for Alvotech, which has been expanding its reach through strategic commercial partnerships that provide global reach and leverage expertise in various markets Alvotech gets approval for three biosimilars in Japan^[2].

Alvotech's pipeline includes eight biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. The company's partnership model, which relies on distribution alliances rather than building its own sales infrastructure, has proven successful, enabling rapid expansion and allowing Alvotech to concentrate resources on development and manufacturing Here's How ALVO's Commercial Partnerships Are Driving Top-line Growth^[3].

In the first half of 2025, Alvotech's product revenues surged more than 200% year over year to nearly $205 million, with a significant portion of this growth coming from its immunology biosimilars Here's How ALVO's Commercial Partnerships Are Driving Top-line Growth^[3]. The company's partnerships with Teva Pharmaceuticals, Dr. Reddy’s Laboratories, and Advanz Pharma have contributed to this growth by providing upfront and milestone payments upon achieving regulatory approvals or commercial milestones Here's How ALVO's Commercial Partnerships Are Driving Top-line Growth^[3].

The approval of AVT03, AVT05, and AVT06 in Japan further strengthens Alvotech's position in the biosimilar market. The company is also expanding its pipeline into new therapeutic areas such as neurology and oncology, aiming to build a broader, future-facing pipeline that could support sustained top-line momentum Here's How ALVO's Commercial Partnerships Are Driving Top-line Growth^[3].