Alvotech

Alvotech reports positive adjusted EBITDA and operating profit for Q3 2024, with growth in product revenue and gross margins. The company's pipeline includes multiple European MAA acceptances and a confirmatory clinical study for AVT16. Alvotech also announces FDA approval for a new presentation of SELARSDI™, expanding its label to include Crohn’s disease and ulcerative colitis. Financial highlights include $128 million in product revenue and $210.5 million in license and other revenue for the first nine months of 2024.

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On Nov 4, 2024, Alvotech and Advanz Pharma announced EMA's acceptance of a Marketing Authorization Application for AVT05, Alvotech's biosimilar to Simponi® (golimumab), for treating chronic inflammatory diseases. This is believed to be the first global filing for a Simponi biosimilar, with approval expected in Q4 2025.

Beam Therapeutics reports a patient death in BEAM-101 trial for sickle cell disease, unrelated to the therapy. Sana Biotechnology refocuses on autoimmune assets, reducing workforce. Ring Therapeutics expands in Singapore with new deals. Drug regulators criticized for ignoring forced labor in supply chains. OSE Therapeutics' IL-7 therapy shows positive results in ulcerative colitis trial. Japan's PMDA opens second overseas office in Washington.

EMA accepts Alvotech and Advanz Pharma’s MAA for AVT05, a biosimilar to J&J’s Simponi for treating chronic inflammatory diseases. AVT05 targets TNF alpha, aiming to reduce costs and increase patient access. Positive clinical results in RA patients support its development, mirroring the global biosimilar market growth.

EMA accepts Alvotech and Advanz Pharma’s AVT05 MAA, a biosimilar to J&J’s Simponi, marking the first global MAA filing for a Simponi biosimilar. AVT05 targets chronic inflammatory conditions and is expected to conclude its approval process by Q4 2025.

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EMA accepts Alvotech's AVT05 biosimilar to Simponi®, expected approval Q4 2025.

Alvotech's AVT05, a biosimilar to Simponi (golimumab), has had its Marketing Authorization Application accepted by the European Medicines Agency, with approvals expected by Q4 2025. Alvotech and Advanz Pharma expanded their partnership in May 2023 to include AVT05 and other biosimilars. Positive clinical results for AVT05 were announced in April 2024 and November 2023.