Alvotech Provides Update on BLA of AVT05 (Biosimilar, Simponi)

Shots: The US FDA has issued a CRL related to the BLA for AVT05, a biosimilar version of Simponi (golimumab), in PFS & autoinjector formulations The CRL noted certain deficiencies from the FDA’s Jul 2025 pre-license inspection of Alvotech’s Reykjavik facility that must be resolved before AVT05 BLA approval, though no other issues were found,…

ByRidhi RastogiNovember 3, 2025

NEWS

Alvotech and Advanz Pharma Report the EMA’s MAA Acceptance of AVT23 (Biosimilar, Xolair)

Shots: The EMA has accepted MAA of AVT23, a proposed biosimilar of Xolair (omalizumab), following the MHRA’s MAA acceptance earlier this year AVT23 was jointly developed by Alvotech & Kashiv BioSciences, with Advanz Pharma obtaining commercial rights to AVT23 in the EEA, UK, Switzerland, Canada, Australia and New Zealand Omalizumab is a humanized mAb that…

ByRidhi RastogiOctober 6, 2025

NEWS

Kashiv Biosciences submits a BLA to the US FDA and receives EMA MAA acceptance for ADL-018 (Biosimilar, Xolair)

Shots: Kashiv BioSciences submitted a BLA to the US FDA and received EMA MAA acceptance for ADL-018, a proposed biosimilar to Xolair (omalizumab) ADL-018 is a humanized mAb biosimilar to Xolair (omalizumab), designed to block IgE binding on mast cells and basophils. Xolair is approved for CSU (≥12 yrs), moderate-to-severe asthma (≥6 yrs), chronic rhinosinusitis…

ByDipanshu DixitOctober 6, 2025

NEWS

Alvotech’s Gobivaz (Biosimilar, Simponi) Receives the CHMP’s Positive Opinion to Treat Several Chronic Inflammatory Diseases

Shots: The CHMP has recommended Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis, PsA, ankylosing spondylitis & ulcerative colitis in adult pts & juvenile idiopathic arthritis across 30 EEA states In trials, Gobivaz demonstrated comparable efficacy, safety, & immunogenicity to Simponi in pts…

ByRidhi RastogiSeptember 24, 2025

NEWS

Alvotech Receives the CHMP’s Positive Opinion for AVT03 (Biosimilar, Prolia & Xgeva)

Shots: The CHMP has recommended AVT03, a biosimilar version of Amgen’s Prolia & Xgeva (denosumab) for the treatment of bone & skeletal disorders STADA & Dr. Reddy’s have semi-exclusive commercial rights to AVT03 in the EU, incl. Switzerland & the UK, leading to STADA marketing it as Kefdensis (Prolia; 60mg/mL PFS) & Zvogra (Xgeva; 70mg/mL single-use…

ByRidhi RastogiSeptember 23, 2025

NEWS

STADA Receives the CHMP’s Positive Opinion for Kefdensis and Zvogra (Biosimilar, Prolia & Xgeva)

Shots: The CHMP has recommended Kefdensis and Zvogra, a biosimilar version of Amgen’s Prolia & Xgeva (denosumab) for the treatment of bone & skeletal disorders Kefdensis (biosimilar to Prolia) received CHMP approval for treating osteoporosis in high-risk postmenopausal women and men with an increased risk of fractures. Zvogra (biosimilar to Xgeva) received CHMP approval for preventing skeletal events…

ByDipanshu DixitSeptember 19, 2025

NEWS

Alvotech Reports Marketing Approval of Three New Biosimilars Across Japan

Shots: Alvotech has reported that its partner Fuji Pharma has received Japanese approval for three biosimilars: AVT03 (Biosimilar, Ranmark), AVT05 (Biosimilar, Simponi), and AVT06 (Biosimilar, Eylea) In Japan, AVT03 (denosumab-biosimilar to Ranmark/Xgeva) was approved for bone lesions from multiple myeloma or solid tumor metastases; AVT05 (golimumab biosimilar to Simponi) for rheumatoid arthritis Pts. who are…

ByRidhi RastogiSeptember 19, 2025

INSIGHTS+

Key Biosimilars Events of August 2025

Shots: Biosimilars are developed to be highly similar of approved biologics in terms of safety, purity, and potency   Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients   Alvotech and Advanz Pharma Receive the EC’s Approval for Mynzepli (Biosimilar, Eylea). Our…

ByDipanshu DixitSeptember 2, 2025

NEWS

Alvotech and Advanz Pharma Receive the EC’s Approval for Mynzepli (Biosimilar, Eylea)

Shots: The EC has approved Mynzepli (AVT06), a biosimilar version of Eylea (aflibercept) for all indications of the reference product in all 30 EEA states; AVT06’s Dossiers are under review in multiple regions incl. the US & Japan Approval was based on extensive analytical, non-clinical & clinical data incl. a confirmatory study assessing Mynzepli vs…

ByRidhi RastogiAugust 21, 2025

NEWS

Alvotech Partners with Advanz Pharma to Commercialize AVT10 (Biosimilar, Cimzia) in the EU

Shots: Alvotech has entered into a supply & commercialization agreement with Advanz Pharma for AVT10, a biosimilar version of Cimzia (certolizumab pegol) Alvotech & Advanz Pharma have previously partnered on biosimilars for over 10 reference biologics, with a plan to launch their first biosimilars in the EU by Q4’25 Cimzia binds with both soluble &…

ByRidhi RastogiJuly 2, 2025

Alvotech Provides Update on BLA of AVT05 (Biosimilar, Simponi)

Alvotech and Advanz Pharma Report the EMA’s MAA Acceptance of AVT23 (Biosimilar, Xolair)

Kashiv Biosciences submits a BLA to the US FDA and receives EMA MAA acceptance for ADL-018 (Biosimilar, Xolair)

Alvotech’s Gobivaz (Biosimilar, Simponi) Receives the CHMP’s Positive Opinion to Treat Several Chronic Inflammatory Diseases

Alvotech Receives the CHMP’s Positive Opinion for AVT03 (Biosimilar, Prolia & Xgeva)

STADA Receives the CHMP’s Positive Opinion for Kefdensis and Zvogra (Biosimilar, Prolia & Xgeva)

Alvotech Reports Marketing Approval of Three New Biosimilars Across Japan

Key Biosimilars Events of August 2025

Alvotech and Advanz Pharma Receive the EC’s Approval for Mynzepli (Biosimilar, Eylea)

Alvotech Partners with Advanz Pharma to Commercialize AVT10 (Biosimilar, Cimzia) in the EU

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