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Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast™ updates below.
Scientific Name: aflibercept

Alteogen completes Ph I trials for ALT-L9 (biosimilar aflibercept)

March 5, 2021

Korea Biomedical Review reported that Alteogen has completed Ph I trials of ALT-L9 (proposed aflibercept biosimilar).

Cipla expands biosimilar partnership with Alvotech for ANZ

March 2, 2021

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

February 12, 2021

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

February 8, 2021

Celltrion announces it has commenced Ph III trials of its proposed aflibercept biosimilar.

Ocumension Therapeutics announces agreement with Shandong Boan Biological Technology to develop aflibercept

October 30, 2020

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

June 30, 2020

Samsung Bioepis announces it has commenced Ph III trials of SB15, proposed aflibercept biosimilar.

Samsung Bioepis announces approval to commence global trial of aflibercept

June 15, 2020

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

May 22, 2020

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

May 15, 2020

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

November 6, 2019

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

November 3, 2019

Gene Techno Science and Kishi Kasei announce agreement for the joint development of an aflibercept biosimilar.

Alteogen announces Ph I clinical trials of aflibercept

October 12, 2019

Alteogen announces Phase I clinical trials of biosimilar aflibercept candidate will begin this month.

Regeneron announces FDA approval for Eylea® in 2mg prefilled syringe

August 13, 2019

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.

Alteogen announces new drug application for aflibercept

February 22, 2019

Alteogen announces new drug application to the Ministry of Food and Drug Safety for aflibercept biosimilar, ALT-L9.

Regeneron announces $4.07 billion in 2018 US net sales for Eylea®

January 7, 2019

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

January 4, 2019

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.

Regeneron announces completion of Phase III clinical trials of Eylea®

October 25, 2018

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

October 1, 2018

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

May 10, 2018

Coherus BioSciences discloses that preclinical studies will be ongoing in 2018 for CHS-2020 biosimilar aflibercept.

Alteogen announces completion of pre-clinical studies of aflibercept

January 17, 2018

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

January 3, 2018

Mylan and Momenta announce deal relating to the development of M710, biosimilar aflibercept.  Pivotal clinical trials are planned for early 2018.