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2023
Alvotech announced that its pharmacokinetic study of AVT05, its Simponi®/Simponi Aria® (golimumab) biosimilar, met its primary endpoint. The study assessed the pharmacokinetics, safety and tolerability of AVT05 compared to Simponi® in healthy adult subjects.
Alvotech announced the study in January 2023. In May 2023, Alvotech announced a study in adult patients with moderate to severe rheumatoid arthritis.
Alvotech has provided updates on some of its biosimilar products in its report on its financial results for the first 3 months of 2023.
- As previously reported, Alvotech initiated a confirmatory patient study for AVT05, its proposed biosimilar to Simponi® and Simponi Aria® (golimumab).
- In March 2023, Alvotech provided Biosana Pharma a notice of termination for the licensing agreement between the two companies relating to AVT23, biosimilar to Xolair® (omalizumab). The deal was announced in February 2022.
Alvotech announced that it has initiated a confirmatory patient study to compare the efficacy, safety, and immunogenicity of AVT05, its golimumab biosimilar, and Simponi® in adult patients with moderate to severe rheumatoid arthritis.
In January 2023, Alvotech announced the initiation of a pharmacokinetic study for AVT05.
Alvotech announced the initiation of a pharmacokinetic study for AVT05 (biosimilar golimumab candidate to Janssen’s Simponi® and Simponi Aria®). Alvotech’s portfolio also includes AVT02 (high concentration adalimumab/biosimilar to Humira®) which launched in Canada in April 2022 and Europe in June 2022 and is expected to launch in the US from July 2023; AVT04 (ustekinumab/biosimilar candidate to Stelara®) for which Alvotech recently announced positive topline results; AVT04 (aflibercept/biosimilar candidate to Eylea®) and omalizumab/biosimilar to Xolair®.
2022
Janssen published data from its Ph IIa clinical trials of guselkumab with golimumab in the treatment of ulcerative colitis. Janssen reported that adults with moderately to severely active ulcerative colitis (UC) who received 12 weeks of combination induction therapy with guselkumab and golimumab, followed by a transition to guselkumab alone for maintenance, achieved a higher clinical remission rate than induction and maintenance treatment with either guselkumab alone or golimumab alone.
Lupin and DKSH announced that they have signed an exclusive licensing and supply agreement to market five of Alvotech’s biosimilar products in the Philippines. The biosimilars include AVT03 (biosimilar denosumab – Prolia® and Xgeva®), AVT05 (biosimilar golimumab/Simponi®) and AVT06 (biosimilar aflibercept/Eylea®) as well as two undisclosed proposed biosimilars for immunology and oncology.
Janssen released data from a Ph 2a clinical trial of guselkumab and golimumab in ulcerative colitis. Janssen reported that the combination induced higher rates of clinical response, clinical remission, endoscopic improvement and a composite histologic-endoscopic endpoint at 12 weeks that either treatment alone.
2021
Alvotech and Oaktree Acquisition Corp. II announced that they have entered into a merger agreement for the creation of a publicly-traded global biopharmaceutical company. Alvotech is led by a team of highly experienced biopharma leaders, including Mark Levick as CEO, Anil Okay as CCO, and Philip Caramanica as Chief IP Counsel and Deputy General Counsel. The merger is expected to deliver gross proceeds to Alvotech in excess of USD$450 million. Alvotech currently has seven products in its pipeline, including a biosimilar candidate to Humira® (adalimumab), Stelara® (ustekinumab), Eylea® (aflibercept), Prolia®/Xgeva® (denosumab) and Simponi®/Simponi ARIA® (golimumab).
Cipla and Alvotech announced that they have expanded their partnership for the marketing and distribution of four biosimilar medicines in Australia and New Zealand. The agreement includes biosimilar aflibercept, ustekinumab, denosumab and golimumab candidates. This agreement is in addition to the previous agreement between Alvotech and Cipla for the commercialisation of AVT02 (biosimilar adalimumab candidate).
The FDA extended the indications of Simponi Aria® (golimumab) to include fatigue in patients with psoriatic arthritis and rheumatoid arthritis. This is the first TNF inhibitor approved to include fatigue improvement in its labeling.
2020
Docwirenews reports a new post-approval safety surveillance study of Janssen’s golimumab Simponi® demonstrated that there is no association between exposure to golimumab and an increased risk of prespecified outcomes.
Bio-Thera Solutions annnounces a licensing agreement with Pharmapark for BAT2506 (biosimilar golimumab candidate). Under the agreement, Pharmapark will have exclusive rights to distribute and market the drug in Russia and other CIS countries.
Bio-Thera Solutions annnounces a licensing agreement with Pharmapark for BAT2506 (biosimilar golimumab candidate). Under the agreement, Pharmapark will have exclusive rights to distribute and market the drug in Russia and other CIS countries.
Ankylosing Spondylitis News reports new data from Germany indicates Simponi® (golimumab) is an effective therapy for people with ankylosing spondylitis and other chronic inflammatory conditions, regardless of pre-treatment with other TNF inhibitors.
J&J announces it has filed two supplemental marketing applications for Simponi Aria (golimumab) with the FDA. J&J have applied for the additional indications of polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis in patients at least two years old.
2019
Bio-Thera announced it has initiated Ph I trials for BAT 2506 (golimumab biosimilar).
Product specific reports based on extracts from our BioBlast® database
aflibercept | Eylea® | Regeneron
bevacizumab | Avastin® | Roche/Genentech
cetuximab | Erbitux® | BMS/Merck
darbepoetin | Aranesp® | Amgen
denosumab | Prolia®/Xgeva® | Amgen
dupilumab | Dupixent® | Sanofi-Aventis
eculizumab | Soliris® | Alexion
filgrastim (GCSF) | Neupogen® | Amgen
golimumab | Simponi® | Janssen
guselkumab | Tremfya® | Janssen
infliximab | Remicade® | Johnson & Johnson
ixekizumab | Taltz® | Eli Lilly
natalizumab | Tysabri® | Biogen/Elan
omalizumab | Xolair® | Genentech / Novartis
pegfilgrastim | Neulasta® | Amgen
pembrolizumab | Keytruda® | Merck
ranibizumab | Lucentis® | Genentech
regdanvimab | Regkirona® | Celltrion
risankizumab | Skyrizi® | AbbVie
rituximab | Rituxan®/MabThera® | Genentech/Biogen
secukinumab | Cosentyx® | Novartis
tocilizumab | Actemra® | Roche
trastuzumab | Herceptin® | Roche/Genentech
BioBlast® Editor and Contributing Author
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