biopharma-reporter6d
EMA accepts Alvotech and Advanz Pharma’s Marketing Authorization Application for biosimilar of J&J’s Simponi
The Simponi biosimilar, AVT05, has shown positive top-line results in patients with moderate to severe rheumatoid arthritis.
Pharmaceutical Technology on MSN6d
EMA accepts Alvotech and Advanz Pharma’s AVT05 MAA
The EMA has accepted a MAA for Alvotech and Advanz Pharma’s AVT05, a proposed biosimilar to Johnson & Johnson’s (J&J) Simponi ...
Alvotech’s AVT05 Biosimilar Application Accepted by EMA
Alvotech (ALVO) has released an update. Alvotech, in collaboration with Advanz Pharma, has announced the acceptance of its Marketing ...
European Medicines Agency Confirms Acceptance of Marketing Authorization Application for AVT05, a Proposed Biosimilar to Simponi® (golimumab)
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for ...
JD Supra24d
Teva’s Denosumab Biosimilar Candidate is Accepted for Review by FDA and EMA
Teva anticipates that the FDA’s decision and EMA’s opinion will come out in the second half of 2025. According to Steffen Nock, PhD, Head of Biosimilars and Chief Scientific Officer at Teva ...
pharmaphorum4d
Fourth Humira biosimilar set for EU approval
EMA advisors at the Committee for Medicinal Products for Human Use (CHMP) recommended Sandoz’s adalimumab Humira biosimilar under three brand names – Halimatoz, Hefiya and Hyrimoz. The firm ...
Alvotech announces EMA acceptance of MAA for AVT05
Alvotech (ALVO) and Advanz Pharma announced that the European Medicines Agency has accepted a Marketing Authorization Application for AVT05, ...
Pharmabiz20d
EMA’s human medicines committee recommends marketing approval for Accord Healthcare’s Imuldosa, a ustekinumab biosimilar to Stelara
of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorisation for Imuldosa (development code: DMB-3115), a biosimilar of Stelara (ustekinumab), marketed ...
Nasdaq7d
Alvotech’s AVT05 Biosimilar Application Accepted by EMA
Alvotech, in collaboration with Advanz Pharma, has announced the acceptance of its Marketing Authorization Application for AVT05, a proposed biosimilar to Simponi, by the European Medicines Agency.
Drug Store News28d
Teva’s Prolia biosimilar candidate accepted for review by FDA, EU EMA
The FDA’s anticipated decision and EMA’s expected opinion are anticipated in the second half of 2025. TVB-009P, Teva’s proposed biosimilar to Prolia, is the first of Teva’s internally ...