On January 24, Alvotech and Bioventure, a subsidiary of GlobalOne Healthcare Holding LLC, announced that the Saudi Food & Drug Authority has approved SIMLANDI, a biosimilar referencing HUMIRA (adalimumab), in Saudi Arabia. According to the press release, Bioventure is Alvotech’s exclusive strategic partner for the commercialization of SIMLANDI in the…
On Jan 6, 2023, Alvotech and Teva announced that the FDA has accepted for review a Biologics License Application (BLA) for AVT04, Alvotech’s proposed biosimilar to STELARA (ustekinumab), and stated that the companies anticipate that the FDA’s review will be completed in the second half of 2023. In August 2020,…
Alvotech announced yesterday the initiation of a pharmacokinetic study for AVT05, a biosimilar referencing Johnson & Johnson’s (“J&J”) SIMPONI and SIMPONI ARIA (golimumab). SIMPONI is used to treat certain types of rheumatoid arthritis (RA), active psoriatic arthritis (PsA), active ankylosing spondylitis (AS), and ulcerative colitis (UC). The study will assess…
Alvotech announced yesterday the launch of HUKYNDRA, a high-concentration, low-volume, citrate-free biosimilar to HUMIRA (adalimumab), in Belgium, Bulgaria, Croatia, Czech Republic, Latvia, Romania, and Slovenia. Through a strategic partnership with STADA, Alvotech supplies HUKYNDRA (adalimumab) autoinjectors and pre-filled syringes with drug product and drug substance manufactured in its vertically integrated…
Earlier this week, Biocon Biologics Ltd. announced that it has entered into a strategic out-licensing agreement with Yoshindo Inc. to commercialize ustekinumab and denosumab biosimilars for the Japanese market. Pursuant to the agreement, Yoshindo gets exclusive commercialization rights for the biosimilars in Japan, with an estimated market opportunity of $700…
On August 31, 2022, Biocon Biologics released a statement regarding three recent on-site FDA inspections of seven manufacturing facilities spanning two sites in Bengaluru, India and one site in Johor, Malaysia. The inspections took place between August 11 and August 30, 2022. The inspections were triggered by three preapproval inspections…
Last week Alvotech announced that it has initiated a confirmatory study for its biosimilar candidate to EYLEA®, AVT06 (aflibercept). EYLEA® is indicated for treating a variety of eye disorders including wet AMD, macular edema, and diabetic retinopathy. According to Alvotech, the study “is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence…
Alvotech, a global biotech company focused solely on the development and manufacture of biosimilar medicines announced yesterday that its ordinary shares and warrants will begin trading on Nasdaq today, June 16, under the new ticker symbols “ALVO” and “ALVOW”, respectively. The debut on Nasdaq follows completion of the company’s business…
Alvotech and Stada recently announced the launch of HUKYNDRA® to patients in certain European countries, including France, Germany, Finland, and Sweden. HUKYNDRA® is a biosimilar of HUMIRA® (adalimumab) developed by Alvotech and is authorized for the treatment of a range of inflammatory conditions including psoriasis, Crohn’s disease, and ulcerative colitis….
On May 24, 2022, Alvotech Holdings S.A. (“Alvotech”) announced positive top-line results from a confirmatory clinical trial for AVT04, Alvotech’s proposed biosimilar to STELARA® (ustekinumab). STELARA® is prescribed to treat a variety of inflammatory conditions, including psoriatic arthritis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. Alvotech notes that its trial…