Home / News / BioBlast®

EXPLORE OUR

BioBlast®

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: bevacizumab

CHMP recommends listing Biocon’s Abevmy®(biosimilar bevacizumab)

March 1, 2021

Biocon and Viatris announced that the CHMP has adopted a positive opinion recommending the marking authorisation of Abevmy® (biosimilar bevacizumab). If approved, Abevmy® will be available for the treatment of metastatic colorectal carcinoma, metastatic breast cancer, non-small-cell lung carcinoma, glioblastoma, ovarian, cervical and renal cancer in 100mg and 400mg injections. The decision of the EC is expected in May 2021.

Roche reports huge erosion of YoY CER growth in key areas

February 4, 2021

Roche reports a huge erosion of its year on year CER growth in key areas, attributing this decline to COVID-19 impacts and biosimilars. Roche reported the YoY CER growth of Avastin (bevacizumab) was -25%, with the hematology franchise (including rituximab) at -22% and HER2 franchise (including trastuzumab and pertuzumab) at -8%.

CHMP recommends 13 medicines for approval

January 29, 2021

The CHMP recommends13 medicines for approval. Among the recommendations were two bevacizumab biosimilars, Mabxience’s Alymsys® and STADA’s Oyavas®.

FDA accepts BLA for Bio-Thera’s biosimilar bevacizumab

January 28, 2021
Bio-Thera Solutions announces the FDA has accepted its BLA for BAT1706 (proposed bevacizumab biosimilar).

Innovent signs bevacizumab deal

January 18, 2021

Innovent announces it has signed a licensing agreement with PT Etana Biotechnologies for Byvasda® (biosimilar bevacizumab). Under the agreement, Etana will receive commercialisation rights in Indonesia in exchange for milestone payments and double-digit royalties on net sales.

Innovent receives additional indication in China

December 27, 2020
Innovent announced China’s NMPA has approved Byvasda® (biosimilar bevacizumab) for the additional indication of adult recurrent glioblastoma.

FDA defers action on Biocon’s bevacizumab biosim

December 25, 2020
Biocon announces that it has been informed by the FDA of a deferred action on the BLA for its proposed bevacizumab biosimilar. This deferral was attributed to COVID-19, as the FDA was unable to conduct the required inspection of the manufacturing facility. Biocon is now awaiting dates for the inspection to occur.

Bio-Thera Solutions licenses bevacizumab biosim in Brazil

December 21, 2020
Bio-Thera Solutions announces it has reached a licensing agreement with Biomm SA for BAT1706 (proposed bevacizumab biosimilar). Under the agreement, Biomm will have exclusive rights to distribute and market the drug in Brazil. Bio-Thera has filed license applications for BAT1706 in the US, EU and China.

Bio-Thera submits EU MA for bevacizumab

November 26, 2020

Bio-Thera Solutions announced it has submitted a marketing authorisation application for BAT1706 (proposed bevacizumab biosimilar) in EU.

Innovent releases Ph III sintilimab and bevacizumab results

November 22, 2020

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).

Shanghai Henlius Biotech reports on Ph III bevacizumab trials

November 20, 2020
Shanghai Henlius Biotech reports positive results from Ph III trials of its biosimilar bevacizumab candidate.

Genentech sues Centus over bevacizumab biosimilar

November 15, 2020
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.

 

CHMP adopts positive opinion for Samsung Bioepis’ bevacizumab

November 12, 2020

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.

Henlius and Essex enter co-development and exclusive license agreement for HLX04

October 15, 2020

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.

Centus Biotherapeutics announces EC marketing authorisation for Equidacent®

September 29, 2020

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.

Innovent announces Ph III trial update

September 28, 2020

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.

The Centre for Biosimilars reports data demonstrates positive findings for Ph I trials of HD201

September 17, 2020

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.

Targeted Oncology reports results of Ph III trial of Samsung Bioepis’ SB8

September 3, 2020

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.

Bio-Thera Solutions and BeiGene announce executed agreement

August 24, 2020

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.

Pfizer application to PBS recommended

August 21, 2020

Pfizer’s application to PBS list its biosimilar bevacizumab (Zirabev®) under the same conditions as Avastin® was recommended.

Samsung Bioepis announces EC has granted marketing authorisation for Aybintio®

August 20, 2020

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.

The CHMP recommends marketing authorisation for Equidacent®

July 23, 2020

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.

Cadila Pharma announces launch of Bevaro® in India

July 22, 2020

Cadila Pharma announces it has launched Bevaro® (biosimilar bevacizumab) in India. Bevaro® s indicated for ovarian cancer, glioblastoma, colorectal cancer, breast cancer, lung cancer, cervical cancer and kidney cancer.

Celltrion reports that Ph III trials for CT-P16 are set to commence

July 15, 2020

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.