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Alvotech and Oaktree Acquisition Corp. II announce merger agreement
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).
Celltrion provides update on biosimilars pipeline
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.
Novartis announces results of Ph III trials of Beovu® (brolucizumab) versus aflibercept
Novartis announced the results of its Ph III trials of Beovu® (brolucizumab) versus aflibercept in patients with diabetic macular edema, reporting that Beovu® demonstrated superiority versus aflibercept in key endpoints.
Celltrion reports Q1 2021 financial results
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.
Sandoz to commence Ph III trials of aflibercept biosimilar
Sandoz announced it will commence enrolling patients in MYLIGHT, its Ph III efficacy and safety study of its proposed aflibercept biosimilar. MYLIGHT will assess the efficacy and safety of the biosimilar candidate in comparison to Eylea® in patients with neovascular age-related macular degeneration.
Alteogen completes Ph I trials of proposed aflibercept biosimilar
Alteogen announced it has completed Ph I trials of its proposed aflibercept biosimilar ALT-L9. Alteogen reported that the trial confirmed the safety and efficacy of ALT-L9 were similar to that of Eylea®.
Alteogen completes Ph I trials for ALT-L9 (biosimilar aflibercept)
Korea Biomedical Review reported that Alteogen has completed Ph I trials of ALT-L9 (proposed aflibercept biosimilar).
AU | NZ | Cipla expands biosimilar partnership with Alvotech for ANZ
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).
Roche releases Ph III results of follow-on faricimab
Roche announced new Ph III data shows faricimab (given at intervals of up to four months) is non-inferior compared to aflibercept (given every two months). This may reduce the treatment burden for patients suffering from diabetic macular edema and neovascular age-related macular degeneration.
Celltrion commences Ph III aflibercept trials
Celltrion announces it has commenced Ph III trials of its proposed aflibercept biosimilar.
CN | Ocumension Therapeutics announces agreement with Shandong Boan Biological Technology to develop aflibercept
Ocumension Therapeutics announces it has reached an agreement with Shandong Boan Biological Technology to jointly develop OT-702, a proposed aflibercept biosimilar. Under the agreement, Ocumension has been granted an exclusive license to promote and commercialise the product in mainland China. OT-702 is currently in Ph III trials.
Samsung Bioepis announces commencement of Ph III trials of aflibercept
Samsung Bioepis announces it has commenced Ph III trials of SB15, proposed aflibercept biosimilar.
Samsung Bioepis announces approval to commence global trial of aflibercept
Samsung Bioepis announces it has received approval to commence a global Ph III trial of SB15 (proposed aflibercept biosimilar) in patients with age-related macular degeneration.
Mylan announced that BLA and marketing authorisation under review by FDA and European authorities, biosimilar insulin and aflibercept projects remain on target
JD Supra reports on Mylan’s Q1 earnings call. In the call, Mylan announced that the BLA and marketing authorisation for its bevacizumab candidate is currently under review by the FDA and European authorities. Mylan also confirmed that its biosimilar insulin and aflibercept projects remain on target.
Formycon announces aflibercept is proceeding as expected
Formycon releases an update on its biosimilar portfolio, announcing its biosimilar aflibercept candidate is proceeding as expected, with Ph III clinical trials expected to begin mid-2020.
Biogen and Samsung Bioepis announce partnership for the commercialisation of ranibizumab and aflibercept
Biogen and Samsung Bioepis announce partnership for the commercialisation of biosimilars ranibizumab and aflibercept. The agreement covers the US, Canada, Europe, Japan and Australia. Under the agreement, Biogen will make one $100M upfront payment, with up to $210M payable at additional development, regulatory and sales-based milestones.
Gene Techno Science and Kishi Kasei announce agreement for joint development of an aflibercept biosimilar
Gene Techno Science and Kishi Kasei announce agreement for the joint development of an aflibercept biosimilar.
Alteogen announces Ph I clinical trials of aflibercept
Alteogen announces Phase I clinical trials of biosimilar aflibercept candidate will begin this month.
US | Regeneron announces FDA approval for Eylea® in 2mg prefilled syringe
Regeneron announces FDA approval for Eylea® in 2mg, single dose prefilled syringe. The product is expected to launch this year and will require fewer preparation steps in comparison to the previously approved vials.
KR | Alteogen announces new drug application for aflibercept
Alteogen announces new drug application to the Ministry of Food and Drug Safety for aflibercept biosimilar, ALT-L9.
US | Regeneron announces $4.07 billion in 2018 US net sales for Eylea®
Regeneron announces $4.07 billion in 2018 US net sales for Eylea®, as it awaits the commencement of new clinical trials for a high dose formulation. Additionally, the FDA has assigned 13 May 19 as the action date for a potential new indication in diabetic retinopathy.
Alteogen announces it has been granted a process patent for producing aflibercept
Alteogen announces it has been granted a process patent for producing aflibercept biosimilar, ALT-L9. Alteogen reports the process improves the productivity and quality of large-scale production of fusion proteins.
US | Regeneron announces completion of Phase III clinical trials of Eylea®
Regeneron announces completion of Phase III clinical trials of Eylea® (aflibercept) in patients with moderately severe and severe non-proliferative diabetic retinopathy. The company reported the trial met its one year primary endpoint and key secondary endpoints.
Momenta announces shift in focus from biosimilars to novel therapeutics
Momenta announces a shift in focus from biosimilars to novel therapeutics. The 5 year re-structuring plan will involve cuts to staff of 50%, however the company will continue to develop biosimilar aflibercept candidate M710.
Coherus announces preclinical studies ongoing for aflibercept
Coherus BioSciences discloses that preclinical studies will be ongoing in 2018 for CHS-2020 biosimilar aflibercept.
CN | JP | US | Alteogen announces completion of pre-clinical studies of aflibercept
Korean Biosimilar company Alteogen announces completion of pre-clinical studies relating to ALT-L9, biosimilar aflibercept, and that it intends to file an investigational NDA with the US in 2018. It also intends to roll out aflibercept in Japan (through partner Kissei Pharmaceutical) and China in 2022 “when the patents of the brand-name drug lapse”.
Mylan and Momenta announce aflibercept deal
Mylan and Momenta announce deal relating to the development of M710, biosimilar aflibercept. Pivotal clinical trials are planned for early 2018.
Product specific reports based on extracts from our BioBlast® database
BioBlast® Editor and Contributing Author
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