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2024
On 15 March 2024, CuraTeQ Biologics (a subsidiary of Aurobindo) announced that it successfully completed phase I trials for omalizumab biosimilar (BP11), demonstrating pharmacokinetic and pharmacodynamic equivalence to Genentech’s/Novartis’ US and EU-sourced Xolair®. The trials were conducted on 165 healthy adults in Australia and New Zealand.
CuraTeQ commenced Phase III trials of BP11 in Europe for the treatment of chronic spontaneous or idiopathic urticariaand in India for the treatment of asthma patients. CuraTeQ expects to seek regulatory approval of BP11 in India in 2024 and in regulated markets in 2025.
Each of Celltrion, Glenmark, Teva, Synermore, Sorrento and Kashiv Biosciences also has omalizumab biosimilars in development. Celltrion submitted an A-BLA in the US earlier this week, and applications for approval in Europe in April 2023, Canada in December 2023 and Korea in June 2023.
Celltrion announced that it has submitted an abbreviated Biologics License Application (A-BLA) in the US for approval of CT-P39, as interchangeable biosimilar to Genentech’s Xolair® (omalizumab). Celltrion’s application seeks approval for all Xolair® indications, as well as interchangeability status.
Celltrion submitted applications for CT-P39 in Europe in April 2023, Canada in December 2023 and Korea in June 2023. Celltrion’s is the first reported regulatory submission for omalizumab biosimilars in these jurisdictions. CuraTeQ Biologics (a subsidiary of Aurobindo), Alvotech/Kashiv Biosciences, Teva, Synermore, Glenmark and Sorrento have also been reported to be developing omalizumab biosimilars.
Genentech announced that FDA has approved Xolair® for the reduction of allergic reactions, including anaphylaxis, in adult and paediatric patients aged 1 year and older with IgE-mediated food allergy. The announcement states that Xolair® is the first FDA-approved medicine to reduce allergic reactions in people with food allergies. The approval was based on the Phase III OUtMATCH study in patients allergic to peanuts and at least two other food allergens. Xolair was previously FDA approved for the treatment of asthma, chronic rhinosinusitis and chronic spontaneous urticaria.
Parent company Roche announced submission of the BLA for the food allergy indication in December 2023. Celltrion, Glenmark and Kashiv Biosciences are reported to have omalizumab biosimilars in development.
2023
The Korea Biomedical Review reported that Celltrion has submitted its marketing authorisation application for CT-P39, its biosimilar to Xolair® (omalizumab) to Health Canada. The application includes all Xolair® indications, including allergic asthma, chronic rhinosinusitis and chronic urticaria.
Celltrion applied for European marketing authorisation for CT-P39 in April 2023.
Roche announced that the FDA has accepted for priority review its Biologics License Application (BLA) for Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with an accidental exposure to one or more foods. The BLA relates to treatment of adult and paediatric patients aged one year and older with food allergy. The FDA expects to make a decision on approval in Q1 2024. In the US Genentech (Roche) and Novartis co-promote Xolair®.
The Korea Herald reported that Celltrion has confirmed in its phase III clinical trial that its omalizumab biosimilar CT-P39 is bioequivalent to Genentech/Novartis’ Xolair®. The company presented the final results of its 40 week clinical trial during the American College of Allergy, Asthma and Immunology (ACAAI) 2023 conference in California.
Celltrion is also reported to have submitted its application for approval of CT-P39 in Korea in June 2023 (as well as in Europe in April 2023).
Celltrion reported its 24 week results from the study in April 2023, the same month it reported that it submitted its application to the EMA.
AU | CA | EU | NZ | UK |
Alvotech and Kashiv Biosciences Ink Exclusive License for AVT23 (ADL018) Omalizumab Biosimilar
Alvotech announced it has partnered with Kashiv Biosciences for an exclusive licensing agreement concerning AVT23 (ADL018), a proposed biosimilar to Novartis/Genentech’s Xolair®, extending across 27 EU countries, the UK, Australia, Canada, and New Zealand. Alvotech will receive exclusive commercialization rights, and Kashiv will oversee development and manufacturing.
On 2 October 2023, Kashiv announced it had enrolled its first patient in a phase III study for ADL018.
Kashiv Biosciences announced that it has enrolled its first patient in a phase III clinical study of ADL018, its biosimilar to Novartis/Genentech’s Xolair® (omalizumab). The objective of the study is to compare ADL018 and Xolair® in terms of efficacy, safety, tolerability, and immunogenicity in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamine treatment (NCT05774639).
On 30 June 2023, Kashiv completed a Phase I clinical trial for ADL-018.
Kashiv Biosciences has completed a Phase I study comparing ADL-018, its omalizumab biosimilar, to Xolair® as marketed in the US by Genentech and in Europe by Novartis. The study was a randomized, double blind, three-arm, single dose, parallel group, PK, PD and safety and immunogenicity study following single subcutaneous dosing in 306 healthy, adult subjects.
No results have been posted.
Amneal Pharmaceuticals and Kashiv Bioscience developed Fylnetra™ (biosimilar pegfilgrastim), which was approved by the FDA on 27 May 2022 to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs.
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.
Korea BioMed reported that Celltrion has submitted its application in EMA for CT-P39 (omalizumab), a biosimilar to Genentech/Novartis’ Xolair®. The reference product Xolair® is approved in Europe for the treatment of asthma, chronic spontaneous urticaria and severe chronic rhinosinusitis with nasal polyps, and in other markets. On 10 April 2023, Celltrion announced its phase III safety and efficacy results for CT-P39.
The Korea Herald has reported that Celltrion has confirmed in a phase III study the safety and efficacy of CT-P39, a biosimilar to Genentech/Novartis’ Xolair® to treat asthma and urticaria. The results indicate that CT-P39 prompted the same biological response in terms of efficacy, safety, immunogenicity and pharmacokinetics in patients with chronic spontaneous urticaria treated with Xolair®.
AU | CA | CH | EU | NZ | UK |
Alvotech exclusive agreement with Advanz Pharma regarding omalizumab for EU, UK, CA, CH and ANZ
Alvotech announced that it has entered into an exclusive agreement with Advanz Pharma for the commercialisation of AVT23 (omalizumab, biosimilar to Novartis’ Xolair™). The agreement covers the European Economic Area, UK, Switzerland, Canada, Australia and New Zealand. Alvotech will be responsible for development and manufacture, while Advanz Pharma will handle registration and commercialisation of AVT23.
2022
Alvotech published its first half 2022 financial results, reporting a revenue growth to over $40 million compared to $2.0 million in the first half of 2021 due to recent launches of adalimumab (AV02) in Canada and Europe. The company has $128.4Min cash/equivalents and has current borrowings of $120.8M. Its R&D costs in the same period were 86.9M.
Alvotech “pipeline highlights” includes (amongst other things) an exclusive global licence agreement with BiosanaPharma regarding biosimilar omalizumab/to Xolair®, expanded partnership with Fuji Pharma, the completion and US submission of interchangeability studies for its high concentration adalimumab biosimilar, a US settlement with AbbVie relating to adalimumab and positive results from clinical studies on AVT04 (biosimilar ustekinumab/Stelara®). Alvotech also secured funding of approximately $185M through the OACB merger and PIPE financing.
The Centre for Biosimilars reported on a study on Celltrion’s CT-39 (biosimilar omalizumab) presented at the American Academy of Allergy Asthma and Immunology annual meeting. Celltrion reported that the study demonstrated equivalence with Xolair® (omalizumab).
Selexis SA and Generium JSC announced the launch of Genolar® (biosimilar omalizumab) in Russia.
Alvotech announced that it has entered into an exclusive global licensing agreement with BiosanaPharma for the co-development of AVT23(BP001), a biosimilar omalizumab candidate.
2021
Celltrion announced its Q3 2021 financial results. Celltrion reported that Remsima® (infliximab biosimilar) has obtained a 53% market share in Europe and 21% market share in Japan. Celltrion reported that Truxima® (rituximab biosimilar) has obtained a 40% market share in Europe and Herzuma® (trastuzumab biosimilar) has obtained a 14% market share in Europe. Celltrion also reported that it expects to launch biosimilar bevacizumab in 2022, biosimilar ustekinumab in 2023, biosimilar omalizumab and aflibercept in 2024 and biosimilar denosumab in 2025.
Syneos Health and CuraTeQ Biologics (a subsidiary of Aurobindo) are recruiting participants for a comparative trial to be conducted in New Zealand to assess the pharmacokinetics, pharmacodynamics, safety and immunogenicity of 3 different products (BP11, US-Xolair and EU-Xolair) containing 150mg of omalizumab as subcutaneous injection in healthy male volunteers. The estimated study completion date is October 2022.
Teva is recruiting participants for a US study to compare the safety and efficacy of TEV-45779 compared to XOLAIR in patients with Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) who remain symptomatic on H1 antihistamine treatment. The estimated study completion date is May 2024.
Taiwan-based Synermore Biologics is recruiting participants for a study to be conducted in Europe and Russia to compare SYN008 and Xolair for the treatment of chronic urticaria not well controlled by antihistamines.
Celltrion released its Q1 2020 financial results, reporting that YoY sales of Celltrion biosimilars increased by 23%. Celltrion announced that it is planning to complete Ph III trials of biosimilar bevacizumab in the first half of 2021, and that ustekinumab, aflibercept, omalizumab and denosumab candidates remain in Ph III trials.
2020
Korea Biomedical Review reports Celltrion has received approval for Ph III trials of CT-P39 (proposed omalizumab biosimilar).
In an interview with the Centre for Biosimilars, Celltrion’s head of marketing, Byoungseo Choi reports Phase I and III trials of Celltrion’s omalizumab candidate are ongoing, and are expected to conclude by 2022.
BiosanaPharma releases the results of Ph I trials of BP001 (omalizumab), reporting comparability to Xolair®.
2019
Celltrion announces start of Phase I Clinical trials of omalizumab biosimilar, with Phase III trials expected to begin in the first half of 2020.
Biosana announces approval for Phase 1 trials of biosimilar omalizumab, with results expected in the fourth quarter of 2019.
2018
Glenmark releases Phase I results of biosimilar omalizumab, suggesting similarity in pharmacokinetic, pharmacodynamic, safety and immunogenicity profiles to Xolair®.
2016
Sorrento releases results of Phase II and III clinical trials of biosimilar omalizumab, announcing the candidate STI-004 demonstrated clinical efficacy and safety.
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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