Avastin® | Bevacizumab | Roche/Genentech

25 Nov 20 | EU | Bio-Thera Solutions announces it has submitted a marketing authorisation application for BAT1706 (proposed bevacizumab biosimilar) in EU.

 

22 Nov 20 | All | Innovent releases results of Ph III trials of Tyvyt® (sintilimab) with Byvasda® (biosimilar bevacizumab) as first-line treatment in patients with Advanced Hepatocellular Carcinoma (HCC).

 

15 Nov 20 | US | Genentech files a complaint against Centus Biotherapeutics, Fujifilm Kyowa Kirin Biologics, Fujifilm Corp and Kyowa Kirin relating to its proposed bevacizumab biosimilar. Genentech asserts that Centus failed to provide sufficient information for Genentech to complete an analysis of potential patent infringements.

 

12 Nov 20 | EU | Samsung Bioepis | The CHMP adopts a positive opinion for the marketing approval for Samsung Bioepis' Onbevzi® (biosimilar bevacizumab). Onbevzi® will be available as a 25mg/mL concentrate for solution for infusion, and is indicated for the treatment of carcinoma or the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

 

15 Oct 20 | All | Henlius, Essexz | Henlius and Essex announce they have entered into a co-development and exclusive license agreement for HLX04 (proposed bevacizumab biosimilar). Under the agreement, Essex will be granted an exclusive license to develop, manufacture and commercialise HLX04 globally. Essex will be responsible for 80% of the costs and expenses in relation to the development of HLX04. Henlius is entitled to milestone payments of up to US$43 million, as well as royalties of up to 10% of annual net sales of the product.

 

29 Sep 20 | EU | Centus Biotherapeutics | Centus Biotherapeutics announces it has received EC marketing authorisation for Equidacent® (biosimilar bevacizumab). Equidacent® has been exclusively licensed to Fujifilm Kyowa Kirin Biologics on a worldwide basis.

 

28 Sep 20 | All | Innovent | Innovent announces its ph III trial of Byvasda® (proposed bevacizumab biosimilar) in combination with Tyvyt® (sintilimab) met its primary endpoints of progression-free survival and overall survival. Innovent reported that the safety profile of both products was consistent with previously reported studies, and no new safety signals were identified.

 

17 Sep 20 | All | PrestigeBiopharma | The Centre for Biosimilars reports that data presented at the ESMO Virtual Congress by PrestigeBiopharma demonstrates positive findings for Ph I trials of HD201 (proposed bevacizumab biosimilar). HD201 is current under review by the EMA.

 

03 Sep 20 | All | Samsung Bioepis | Targeted Oncology reports the results of a Ph III trial of Samsung Bioepis' proposed bevacizumab biosimilar, SB8. The researchers reported that the objective response rate ratio of SB8 and bevacizumab appeared equivalent, with comparable safety, pharmacokinetics and immunogenicity as a treatment of patients with metastatic or recurrent nonsquamous non-small cell lung cancer.

 

24 Aug 20 | CN | Bio-Thera, BeiGene | Bio-Thera Solutions and BeiGene announce they have executed a license / distribution and supply agreement for BAT1706 (proposed bevacizumab biosimilar). Subject to approval by Bio-Thera's shareholders in September, the agreement grants BeiGene the right to develop, manufacture and commercialise BAT1706 in mainland China, Hong Kong, Macau and Taiwan in return for milestone payments totalling US$165M, and tiered double-digit royalties on future net product sales.

 

21 Aug 20 | AU | Pfizer | Pfizer's application to PBS list its biosimilar bevacizumab (Zirabev®) under the same conditions as Avastin® was recommended.

 

20 Aug 20 | EU | Samsung Bioepis | Samsung Bioepis announces that the EC has granted marketing authorisation for Aybintio®, biosimilar bevacizumab (Avastin®) with a full indication set. EMA accepted Samsung's application on 19 July 2019, and CHMP positive opinion was granted on 26 June 2020. This is Samsung's 5th approved EU biosimilar, and the 3rd approved biosimilar to bevacizumab (following the approval of Amgen/Allergan's Mvasti® in January 2018 and Pfizer's Zirabev® in December 2018). Centus Biotherapeutics' application for Equidacent® follows Samsung's closely, having received CHMP positive opinion in July 2020.

 

23 Jul 20 | EU | Centus Biotherapeutics | The CHMP adopts a positive opinion recommending the granting of marketing authorisation for Centus Biotherapeutics' Equidacent® (biosimilar bevacizumab) for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer and carcinoma of the cervix.

 

22 Jul 20 | IN | Cadila | Cadila Pharma announces it has launched Bevaro® (biosimilar bevacizumab) in India.  Bevaro® is indicated for ovarian cancer, glioblastoma, colorectal cancer, breast cancer, lung cancer, cervical cancer and kidney cancer.

 

14 Jul 20 | All | Celltrion | In an interview with the Centre for Biosimilars, Celltrion's head of marketing, Byoungseo Choi reports that Phase III trials for CT-P16 (proposed biosimilar bevacizumab) are set to commence, with EU submission planned for next year. 

 

08 Jul 20 | US | Genentech, Amgen | Genentech and Amgen file stipulations in the US District Court of Delaware dismissing their BPCIA litigation relating to trastuzumab and bevacizumab biosimilars. This comes after the Court of Appeals refused to block Amgen's Mvasi® from entering US markets on July 06.

 

07 Jul 20 | All | Outlook Therapeutics | Outlook Therapeutics announces it has completed patient enrollment for its NORSE 2 clinical trials of Lytenava® (proposed bevacizumab biosimilar).

 

30 Jun 20 | AU | Amgen | Amgen receives Australian approval for Mvasi® (biosimilar bevacizumab) for all indications as Avastin®.

 

28 Jun 20 | US | Genentech, Samsung Bioepis | Genentech files a complaint against Samsung Bioepis in the District Court of Delaware under the BPCIA, alleging infringement of 14 patents related to SB8 (Samsung's proposed bevacizumab biosimilar), and violation of the "patent dance" provisions.

 

26 Jun 20 | EU | Samsung Bioepis | Samsung Bioepis announces the CHMP has adopted a positive opinion for Aybintio® (biosimilar bevacizumab).

 

19 Jun 20 | CN | Bio-Thera | Bio-Thera Solutions announces China's NMPA has accepted its BLA for BAT1706 (proposed bevacizumab biosimilar).

 

19 Jun 20 | CN | Innovent | Innovent Biologics announces China's NMPA has approved Byvasda® (bevacizumab) for the treatment of patients with advanced non-small cell lung cancer and metastatic colorectal cancer in China.

 

16 Jun 20 | All | Henlius | Henlius Biotech announces the results of Ph III trials of HLX04 (proposed bevacizumab biosimilar) in combination with oxaliplatin and fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer. Henlius reports that the study successfully met the primary endpoint.

 

04 Jun 20 | US | Genentech, Amgen | Bloomberg Law reports on the ongoing US Court of Appeals for the Federal Circuit dispute between Genentech and Amgen regarding bevacizumab. In a hearing on 3 June 2020, Genentech asked the Court to prevent Amgen selling its biosimilar bevacizumab Mvasi® to new patients, despite the trial Court refusing to prevent Amgen's launch, and the US Court of Appeals refusing to injunct Amgen early in the appeal. Decision reserved.

 

25 May 20 | US | Pfizer | the American Journal of Managed Care reports two cost savings studies presented at a virtual meeting of the International Society for Pharmacoeconomics and Outcomes Research. The studies, which were sponsored by Pfizer, analysed the potential cost savings over a three year period from a US perspective in switching to bevacizumab and rituximab biosimilars. The studies concluded that over three years $14.7 million could be saved on bevacizumab used to treat 503-676 patients, with $3.8 million saved on rituximab used to treat 754-764 patients.

 

22 May 20 | All | Mylan | 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.

 

08 May 20 | All | AryoGen | The American Journal of Medical Care publishes results of clinical trials of AryoGen's BE1040V, biosimilar bevacizumab. Researchers reported the product was non-inferior to the reference product in terms of efficacy for the treatment of metastatic colorectal cancer.

 

06 Mar 20 | US | Mylan | In its 2019 Q4 earnings call, Mylan announces the FDA has accepted its aBLA for a proposed bevacizumab biosimilar. The FDA's decision is expected on or before December 27, 2020.

 

03 Feb 20 | All | Bio-Thera | Bio-Thera announces BAT1706 (bevacizumab candidate) met the primary endpoint in Ph III clinical trials.

 

13 Jan 20 | US | Coherus, Innovent | Coherus announces licensing agreement with Innovent for the commercialisation of Innovent's bevacizumab candidate, with plans to file an aBLA in late 2020 or early 2021.

 

06 Jan 20 | US | Pfizer | Pfizer launches bevacizumab biosimilar Zirabev® in the US, at a 23% discount to Avastin® .

 

14 Dec 19 | CN | Qilu | Qilu receives Chinese approval for its bevacizumab biosimilar, Ankada®. 

 

21 Nov 19 | AU | Pfizer | Pfizer receives Australian approval for bevacizumab biosimilar, Zirabev®.

 

19 Nov 19 | US | Samsung Bioepis | FDA accepts BLA for proposed bevacizumab biosimilar.

 

12 Oct 19 | All | Prestige Biopharma | Prestige releases details of upcoming Phase III clinical trials of biosimilar bevacizumab candidate. zi

 

19 Sep 19 | All | Innovent | Innovent releases results of Phase III clinical trials of bevacizumab biosimilar, reporting no statistical difference in media progression-free survival rates.

 

09 Sep 19 | All | JHL Biotech, Genentech | JHL announces it will immediately cease development and clinical trials of a number of biosimilars including rituximab, trastuzumab and bevacizumab as part of a settlement deal with Genentech. This agreement settles the 2018 dispute between the two parties, in which it was alleged that JHL had illegally obtained trade secrets from Genentech relating to these products. 

 

05 Sep 2019 | All | TOT Biopharm | TOT Biopharm releases results of Phase I study of proposed BmAb biosimilar, reporting PK similarity and safety in comparison to the originator.

 

29 Aug 2019 | All | Henlius Biotech | Henlius commences recruitment for Phase I clinical trial of bevacizumab candidate. The trial will enrol 30 patients with solid tumours and is expected to commence in September 2019.

 

19 Aug 2019 | IN | Dr Reddy's | Dr Reddy's launches bevacizumab biosimiliar Versavo® in India. The product is available in 100mg and 400mg single use vials and is indicated for the treatment of metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, cervical cancer, metastatic breast cancer and epithelial ovarian, fallopian tube and primary peritoneal cancer.

 

19 Jul 2019 | EU | Samsung Bioepis | Samsung announces that its application for BmAb candidate SB8 has been accepted for review by the EMA.

 

19 Jul 2019 | US | Amgen, Allergan | Amgen launches Mvasi® in the US. Mvasi is approved for five types of cancer and was the first oncology therapeutic biosimilar approved by the FDA. 

 

28 Jun 2019 | US | Pfizer | FDA approves Pfizer's bevacizumab biosimilar, Zirabev® for the treatment of metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer; recurrent gliobastoma; metastatic renal cell carcinoma; and persistent, recurrent or metastatic cervical cancer.

 

03 Jun 2019 | All | Innovent Biologics | Innovent presents results of efficacy and safety study of BmAb biosimilar at the Annual Meeting of the American Society of Clinical Oncology (ASCO).

 

20 May 2019 | US | Genentech, Pfizer | Genentech moves to dismiss Pfizer's counter-claims, claiming that BPCIA legislation prevents any declaratory judgement as Pfizer did not comply with requirements during the 'patent dance'.

 

29 Apr 2019 | US | Genentech, Pfizer | Pfizer responds to Genentech's complaint, seeking declaratory judgement of invalidity and noninfringement of all of the patents in Genentech's complaint.

 

05 Apr 2019 | US | Genentech, Pfizer | Genentech files complaint against Pfizer in the District Court of Delaware alleging infringement of 22 patents and requesting a declaratory judgment of infringement of several of these patents.

 

19 Feb 2019 | EU | Pfizer | Pfizer announces EU approval for Zirabev®, biosimilar BmAb.

 

14 Jan 2019 | US | Bio-Thera, Cipla | Bio-Thera announces partnership with Cipla to commercialise BmAb candidate in emerging markets. 

 

14 Dec 2018 | EU | Pfizer| The EMA's Committee for Medicinal Products for Human Use recommends approval of Pfizer's BmAb biosimilar Zirabev®.  This is Pfizer's second oncology biosimilar to receive positive EMA opinion this year.

 

13 Dec 2018 | All | Innovent | Innovent announces BmAb candidate met pre-defined endpoints in Phase III trials.

 

15 Oct 2018 | CN | Innovent | BmAb biosimilar approved by China's National Medical Products Administration for clinical development for Non-Small Cell Lung Cancer and hepatocellular carcinoma.

 

15 Oct 2018 | CN | JHL Biotech | BmAb biosimilar approved for Phase I and Phase III Clinical Trials by NMPA. 

 

14 Sep 2018 | US | Amgen | FDA announces approval of Amgen's Mvasi®, the first BmAb biosimilar to gain approval in the US.

 

10 Aug 2018 | ALL | Celltrion | Celltrion set to commence Phase III Clinical Trials for BmAb biosimilar in 150 sites across Europe, Asia and South America.

 

07 May 2018 |US | Amneal/mAbxience | Amneal announces it has entered into a licensing agreement with mAbxience for its US biosimilar bevacizumab.  See subsequent mAbxience announcement here.

 

18 Jan 2018 | EU | Amgen/Allergan | Amgen and Allergan announce the first EU approval of biosimilar bevacizumab, to be marketed as Mvasti®.  Their application was filed with EMEA on 2 Dec 2016.

 

23 Nov 2017 |IN | Biocon/Mylan | Biocon launches Krabeva®, biosimilar bevacizumab, in India.  Read more

 

10 Nov 2017 | EU | Amgen/Allergan | Amgen/Allergan announce the EMA's CHMP has adopted a positive opinion for ABP 215, biosimilar to Avastin® (bevacizumab) for the same indications as the originator. Read more

 

23 Oct 2017 | US | Amgen | Genentech files a further suit under seal (District of Delaware) against Amgen, the third litigation existing between the parties relating to Amgen's Mvasti® (biosimilar bevacizumab). The 25 patents at issue in this suit are the 24 patents included in the first Genentech suit and US patent 7,297,334.  Read more

 

06 Oct 2017 | US | Amgen | Amgen files suit (Central District of California) seeking DJ that 27 patents are invalid/unenforceable/not infringed by Amgen's biosimilar bevacizumab Mvasti®. Read more.    On the same day, Genentech commenced suit in District of Delaware against Amgen relating to Mvasti®, alleging infringement of 24 patents and non compliance with the BPCIA disclosure requirements. Read more

 

17 Oct 2017 | EU | Amgen |  Amgen withdraws EU application for Kyomarc® (biosimilar bevacizumab), for "marketing reasons", but will continue with existing application for Mvasti®.  Read more

 

14 Sep 2017 | US | Amgen/Allergan | Amgen/Allergan's bevacizumab biosimilar (Mvasti®) (bevacizumab-awwb) approved in the US for colorectal, lung, brain, kidney and cervical cancer.  Read more 

 

17 Jul 2017 | All | Celltrion |  Celltrion to commence ph 1 clinical trials for biosimilar bevacizumab in South Korea. Read more

 

13 Jul 2017 | US | Amgen/Allergan | Amgen/Allergan’s biosimilar becvacizumab recommended for approval by FDA ODAC. Read more  

 

13 Jul 2017 | US | Amgen/Allergan | Amgen’s biosimilar BmAb goes before the FDA Oncology Drugs Advisory Committee in the morning session on 13 July 2017. Read more ​

 

15/16 Mar 2017 | US | Hospira (Pfizer) | PTAB institutes IPR filed by Hospira against Genentech on bevacizumab patents IPR2016-01771 (Patent 7,622,115) and IPR2016-01837 (Patent 7,807,799) from requests filed 9 September 2016. 

 

2 Mar 2017 | US | Amgen | Judge Sleet dismissed Genentech's suit filed 15 Feb 17 (see below) under Fed Cir's finding in Amgen v Sandoz.

 

15 Feb 2017 | US | Amgen | Genentech sues Amgen in District Court of Delaware alleging non compliance with BPCIA disclosure obligations in patent dance relating to bevacizumab.  

 

15 Nov 2016 | US | Amgen/Allergan | Amgen and Allergan submit BLA for ABP 215, bevacizumab biosimilar. Read more 

 

 

 

 

 

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Biosimilars Bulletin 

November 9, 2020

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