Herceptin® | Trastuzumab | Roche/Genentech

November 9, 2020

10 Nov 20 | IL | Prestige BioPharma, Teva Israel | Prestige BioPharma and Teva Israel announce they have entered into an exclusive partnership and supply agreement for Prestige's Tuznue® (trastuzumab biosimilar) in Israel. Under the agreement, Prestige is responsible for registration and commercial supply, and Teva Israel will be responsible for local registration, sales and marketing in Israel.

 

13 Oct 20 | BR | Celltrion | Korea Biomedical Review reports Celltrion has signed a contract to provide Herzuma® (biosimilar trastuzumab) and Truxima® (biosimilar rituximab) to the Brazilian Federal Government. Celltrion has also signed a contract to provide Truxima® to the Sao Paulo Provincial Government.

 

24 Sep 20 | UK | Accord Healthcare | Accord Healthcare launches Zercepac® (biosimilar trastuzumab) in the UK. Zercepac® is indicated for HER2-positive early breast cancer, HER2-positive metastatic breast cancer and previously untreated HER2-positive metastatic gastric cancer and is available in a 150mg single-dose vial.

 

14 Aug 20 | CN | Shanghai Henlius Biotech | Shanghai Henlius Biotech announces China's NMPA has approved its trastuzumab biosimilar Zercepac®. Zercepac® is indicated for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer.

 

10 Aug 20 | BR | Samsung Bioepis | Samsung Bioepis launches Ontruzant® (biosimilar trastuzumab) in Brazil. Ontruzant® is indicated for the treatment of metastatic HER2-overexpressing breast cancer, early HER2-overexpressing breast cancer, and advanced gastric cancer.

 

03 Aug 20 | All | Celltrion|  Celltrion gains WHO prequalification for its trastuzumab biosimilar Herzuma®. The prequalification status enables Celltrion to make a bid in global procurement by UN agencies, and is based on an evaluation of safety and efficacy.

 

29 Jul 20 | EU | Shanghai Henlius Biotech, Accord Healthcare | Shanghai Henlius Biotech and Accord Healthcare jointly announce the European Commission has approved Zercepac® (biosimilar trastuzumab) for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer.

 

08 Jul 20 | All | Celltrion | The Journal of Clinical Pathways report a new study shows a triplet regimen of pembrolizumab, Herzuma® (biosimilar trastuzumab) and chemotherapy is effective in patients with HER-2 positive advanced gastric cancer.

 

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. 

 

31 May 20 | EU | Henlius Biotech | Henlius Biotech announces it has received a positive CHMP opinion, recommending marketing authorisation for HLX02 (proposed trastuzumab biosimilar).

 

29 May 20 | All | Prestige Biopharma | The Centre for Biosimilars reports two new studies for HD201 (Prestige Biopharma's proposed trastuzumab biosimilar) were presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology. The first study, TROIKA-I demonstrated that HD201 was safe and well tolerated with PK comparability to the originator. The second, TROIKA was designed to compare safety, PK and efficacy based on the total pathological complete response rate. The investigators reported that the studies demonstrated equivalence between the biosimilar and reference products.

 

27 May 2020 | CN | Henlius Biotech | Henlius Biotech announces that its adalimumab and trastuzumab products are under New Drug Application review, with the potential to be launched in 2020.

 

15 May 2020 | All | Samsung Bioepis | Samsung Bioepis announces the results of a four year follow up study of Ontruzant® (trastuzumab) will be presented at the ASCO20 Virtual Scientific Program organized by the American Society of Clinical Oncology (ASCO) at the end of this month. The study assessed the cardiac safety and surival outcome in a subgroup of patients from the Ph III study.

 

23 April 2020 | EU | Shanghai Henlius Biotech | Henlius Biotech announces it has received two EU GMP certificates related to its trastuzumab biosimilar HLX02.

 

15 April 20 | US | Merck, Samsung Bioepis | Merck and Samsung Bioepis launch Ontruzant® (trastuzumab) in the US. Ontruzant® is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative breast cancer as part of a treatment regimen and as a single agent following multi-modality anthracycline based therapy.

 

30 March 20 | BA | Biocad | Biocad announces it has received registration certificates from Bosnia and Herzegovina for Acellbia® (rituximab) and Herticad® (trastuzumab), with a launch expected in 2020.

 

24 Mar 20 | US | Samsung Bioepis | Samsung Bioepis announces the FDA has approved its 420mg multi-dose vial of Ontruzant® (trastuzumab).

 

16 Mar 20 | US | Teva, Celltrion | Teva and Celltrion launch Herzuma® (trastuzumab) in the US. Herzuma® is indicated for the treatment of breast cancer, metastatic breast cancer and metastatic gastric cancer.

 

09 Mar 20 | US | Amgen, Genentech | The US Federal Court of Appeals for the Circuit Court affirms the lower court's refusal to preliminary injunct Amgen for its sale of biosimilar trastuzumab. Trial is expected to begin on 20 April, 2020.

 

23 Jan 20 | US | Pfizer | Pfizer announces biosimilar TmAb Trazimera® will launch in the US on 15 February at a 22% discount to Herceptin.

 

12 Dec 19 | CN | AffaMed, Samsung Bioepis | AffaMed receives Chinese approval to commence Ph III trials of Samsung's trastuzumab biosimilar SB3.

 

06 Dec 19 | All | NeuClone | NeuClone announces results of Ph I trials of trastuzumab biosimilar, reporting the product successfully met primary and secondary endpoints.

 

02 Dec 19 | US | Mylan, Biocon | Mylan and Biocon announce the launch of Ogivri® in the US.

 

26 Nov 19 | All | Shanghai Henlius Biotech | Shanghai Henlius announces proposed trastuzumab biosimilar met primary endpoint in Phase III clinical trials

 

03 Oct 19 | Celltrion & Juno Pharmaceuticals | Celltrion and Juno announce Australian co-marketing partnership agreement for Herzuma® (trastuzumab) and Truxima® (rituximab). Under the agreement, Celltrion will hold the marketing authorisation and will be responsible for distribution, and Juno will provide sales promotion and hospital contracting services.

 

10 Sep 19 | CA | Celltrion | Celltrion announces Canadian approval for its biosimilar trastuzumab, Herzuma®, for the treatment of HER-2 positive early breast cancer, metastatic breast cancer, and metastatic gastric cancer.

 

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. 

 

22 Aug 19 | JA | Celltrion | Celltrion announces Japanese approval for three-week cycle of Herzuma® for the treatment of breast cancer.
 

01 Aug 19 | AU | Biocon, Mylan | Mylan and Biocon announce the launch of Ogivri® in Australia. This is the first TmAb biosimilar to be listed on the PBS, following approval in December 2018.

 

Jul 19 | AU | Amgen/Celltrion | Both Amgen and Celltrion's biosimilar trastuzumab products, Kanjiti® and Herzuma® respectively, were considered by Australia's PBAC committee for PBS listing and A flagging (substitution).  This follows the May 2019 PBAC recommendations for PBS listing of Mylan and MSD's biosimilar products.

 

22 Jul 2019 | US | Genentech, Amgen | US District Court refuses Genentech's request for a temporary restraining order and preliminary injunction against Amgen following Amgen's launch of biosimilar trastuzumab Kanjinti®. In a memorandum opinion the Court has called Genentech's request 'contrary to the spirit' of the BPCIA, stating that Genentech had been given warning of the upcoming launch in May 2018.

 

18 Jul 2019 | CN | Celltrion/Nan Fung/Vcell | Celltrion announces creation of a JV Co with Nan Fung Group for the commercialisation of Remsima®, Truxima® and Herzuma® in China. The new company Vcell Healthcare will obtain exclusive rights to develop, manufacture and commercialise these three products in mainland China.

 

04 Jul 2019 | US | Samsung Bioepis | Samsung and Genentech settle patent dispute, allowing for the sale of Samsung's Ontruzant®.

 

02 Jul 2019 | All | Prestige BioPharma | Prestige announces agreements with Pharmapark and Mundipharma for the supply and commercialisation of Tuznue® . An agreement reached with Pharmapark allows for supply and commercialisation in Russia, while the agreement with Mundipharma grants an exclusive license and supply of the drug.

 

21 Jun 2019 | EU | Henlius | Henlius announces that EMA has accepted Henlius' MAA for trastuzumab biosimilar HLX02. This is the first Chinese developed TmAb biosimilar to be accepted for review by the EMA.

 

Mar 2019 | AU | Mylan/MSD | The PBAC committee recommends Mylan's Ogivri® and  MSD's Ontruzant® for PBS listing in Australia for all Herceptin® indications, which will trigger a 25% statutory price reduction with the move of the product to the F2 formulary. PBS also approved "a flagging" (substitution).

 

15 Jun 2019 | All | Biocon | Biocon receives good manufacturing practice compliance certificate from the EMA for Bengaluru facilities.

 

13 Jun 2019 | US | Amgen | FDA approves Amgen's biosimilar TmAb Kanjinti® for all indications. 

 

28 May 2019 | EU | Prestige BioPharma | The EMA accepts Prestige Biopharma's Application for trastuzumab biosimilar Tuznue®.

 

22 May 2019 | CA | Mylan/Biocon | Health Canada approves Ogivri® for the treatment of HER2-positive breast cancer and HER2-positive metastatic stomach cancer. The product is the first TmAb biosimilar to be approved in Canada and is expected to be launched in the current quarter.

 

16 May 2019 | AU | Amgen | Amgen receives Australian approval for biosimilar trastuzumab Kanjinti®, in 60mg, 150mg and 420mg dosages. 

 

11 Mar 2019 | US | Pfizer | Pfizer announces FDA approval of biosimilar trastuzumab Trazimera® for the treatment of HER2 positive breast cancer and HER2 metastic gastric or gastroesophageal junction adenocarcinoma.

 

28 Feb 2019 | US | Genentech | FDA approves subcutaneous formulation of Herceptin for the treatment of HER2-overexpressing breast cancer.

 

11 Feb 2019 |  Samsung Bioepis & C-Bridge | Samsung Bioepis announces partnership with C-Bridge to commercialise biosimilars in China. Under the deal, C-Bridge will develop a new company, AffaMed Therapeutics to launch candidates such as ranibizumab, eculizumab and trastuzumab biosimilars.

 

21 Jan 2019 | US | Samsung Bioepis | FDA approves biosimilar trastuzumab for all eligible indications. This is Samsung Bioepis' first oncology biosimilar to receive FDA approval. 

 

09 Jan 2019 | AU | Samsung Bioepis | Samsung Bioepis obtains AU approval for Ontruzant®, biosimilar trastuzumab, in Australia.  This is the third biosimilar TmAb to be approved in AU, following Celltrion's approval of Simabtra® in July 2018, and Mylan's approval of Ogivri® in December 2018.

 

23 Dec 2018 | All | Shanghai Henlius Biotech |  Shanghai Henlius' research team presented an update on its TmAb clinical program with Phase III trials underway in Poland, Ukraine, Phillippines and China. 

 

23 Dec 2018 | All | Prestige Biopharma/Cipla | Prestige announces licensing agreement with Cipla, granting Cipla exclusive rights to distribute and market Prestige's TmAb biosimilar in emerging markets.

 

19 Dec 2018 | EU | Biocon | Biocon announces EU marketing authorisation for biosimilar trastuzumub, Ogivri®. Ogivri® is indicated for the treatment of HER2 positive early breast cancer, metastatic breast cancer and metastic gastric cancer.

 

15 Dec 2018 | US | Celltrion/Teva | FDA approves TmAb biosimilar for the treatment of HER2-positive breast cancer.  Herzuma® is the second TmAb biosimilar to be approved in the US. Celltrion is currently defending the biosimilar against Genentech, and while Genentech and Pfizer have reached a settlement, Celltrion, Amgen and Samsung Bioepis remain in litigation.

 

12 Dec 2018 | All | Pfizer, Genentech | Genentech and Pfizer voluntarily dismiss all claims in litigation commenced in November 2017, each covering their own legal costs. While no details have been published, the dismissal suggests a settlement has been reached.

 

11 Dec 2018 | AU | Alphapharm/Mylan | Alphapharm receives TGA approval for its biosimilar TmAb in Australia (Ogivri®) in 2 dosage forms (150mg, and 440mg powder for injection), four months after Celltrion received approval for its TmAb biosimilar products on 17 July 2018.

 

08 Dec 2018 | US | Samsung Bioepis | Samsung Bioepis announces comparable efficacy and safety to reference Trastuzumab in one-year follow-up study published at the San Antonio Breast Cancer Symposium.

 

28 Nov 2018 | JP | Daiichi Sankyo | Daiichi Sankyo launches first trastuzumab biosimilar in Japan.

 

23 Oct 2018 | All | NeuClone | NeuClone commences Phase I clinical trials for biosimilar trastuzumab.

 

19 Oct 2018 | EU | Mylan/Biocon | Mylan and Biocon announce the CHMP's positive opinion recommending Ogivri® (biosimilar TmAb) for approval in EMA.  Approval is expected before the end of the year.

 

21 Aug 2018 | JP | Celltrion | Nippon Kayaku launches Celltrion's trastuzumab biosimilar in Japan, but only for the treatment of gastric cancers. 

 

31 Jul 18 | EU | Pfizer | Pfizer announces EMA approval of biosimilar trastuzumab, Trazimera® for the treatment of human epidermal growth factor (HER2+) breast cancer and HER2+ metastatic gastric or gastroesophageal junction adenocarcinoma.  This is Pfizer's 4th biosimilar to receive EU approval.

 

27 Jul 2018 | IN | Dr Reddy's Laboraties | Dr Reddy's announces biosimilar trastuzumab available in India for the treatment of HER2-positive cancers. 

 

17 Jul 2018 | AU | Celltrion | Celltrion obtains approval for its biosimilar TmAb products in Australia (150mg products branded as Simabtra®, Herzuma®, and Hertuzu®).  These are the first biosimilar TmAb products to be approved in AU.

 

04 Jul 2018 | EU | Biocon | Biocon receives EU CGMP certification for its facility in Bangalore, clearing the way for the approval of pegfilgrastim and trastuzumab biosimilars.

 

28 Jun 2018 | EU | Prestige Biopharma, Alvogen | Prestige and Alvogen announce partnership to commercialise Prestige's trastuzumab biosimilar, Hervelous®, in Central and Eastern Europe. 

 

17 Jun 2018 | US | Celltrion| Celltrion resubmits application for marketing approval of trastuzumab biosimilar to the FDA. This follows CRLs from the FDA related to the February warning letter regarding Celltrion's manufacturing facility in South Korea.

 

1 Jun 2018 | US | Amgen/Allergan | FDA provides CRL rejecting Amgen's application for biosimilar trastuzumab ABP 980, filed August 2017.  Amgen states "we do not expect this to impact our US launch plans."

 

31 May 2018 | EU | Pfizer | CHMP recommends granting a marketing authorisation to Pfizer for its biosimilar trastuzumab (Trazimera®) for the treatment of breast and gastric cancer.

 

30 May 2018 | US | Celltrion | Celltrion announces that it intends to refile its aBLA for CT-P6 (trastuzumab) in June 2018 with a view to obtaining approval in 2018.

 

02 May 2018 | EU | Mundipharma/Celltrion | Mundipharma announces their biosimilar trastuzumab (in-licensed from Celltrion) is available in Europe. This is Mundi's third biosimilar to be launched in EU, but the second biosimilar TmAb, following MSD's launch in March 2018.

 

23 Apr 2018 | US | Pfizer | Pfizer announces that it has received a CRL from the FDA for its BLA for biosimilar trastuzumab.  The FDA has highlighted the need for further technical information.  

 

06 Apr 2018  | US | Celltrion/Teva | Celltrion announces that the FDA has rejected its BLA for biosimilars to trastuzumab (CT-P6) and rituximab (CT-P10).  The FDA complete response letter (CRL) followed a FDA warning letter received by Celltrion in January this year.  Celltrion promises that the BLAs will be resubmitted "relatively soon" and that approvals are expected "in 6 months after resubmission".   The rejections were received 9 months after the BLAs were filed, and less than 2 months following the EU approval of Celltrion's trastuzumab.

 

23 Mar 2018 | EU | Amgen/Allergan | EMA's CHMP adopted a positive opinion for ABP 980, Amgen/Allergan's trastuzumab biosimilar Kanjinti®, 12 months after they announced filing the EC application.

 

19 Mar 2018 | EU | Mundipharma/Celltrion | Mundi and Celltrion enter exclusive distribution and marketing agreement for biosimilar trastuzumab, Herzuma®, for 7 EU countries including UK, DE and IT.

 

08 Mar 2018 | EU | Merck/Samsung Bioepis | Merck launches the first TmAb biosimilar in Europe by selling the product developed by Samsung Bioepis (SB3) as Ontruzant® in the UK.

 

14 Feb 2018 | EU | Celltrion/Teva | EC approves Celltrion's Herzuma® (biosimilar trastuzumab), 2 months after the positive opinion from the CHMP on 14 December, 2017.  This is Celltrion's third EU approval and the second EU biosimilar trastuzumab approved in 3 months. 

 

11 Jan 2018 | US | Celltrion/Teva | Celltrion and Teva commence proceedings in District Court (Northern District of California) seeking DJ that 38 patents relating to trastuzumab are invalid, unenforceable and/or not-infringed.  This follows Celltrion/Teva's US ABLA filing for biosimilar trastuzumab in late July 2017, and subsequent patent dance, and will test the boundaries of the availability of "DJ-within ABLA". Read more

 

1 Dec 2017 | US | Mylan/Biocon | FDA approves Mylan/Biocon trastuzumab biosimilar Ogivri® for all "on-label" indications.  This is the first US approved trastuzumab biosimilar, and Mylan's first US biosimilar approved.

 

20 Nov 2017 | EU | Samsung Bioepis/MSD | Samsung Bioepis receives regulatory approval for EU's first biosimilar trastuzumab, Ontruzant® (to be marketed by MSD) for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.

 

17 Nov 2017 |US | Pfizer | Roche sues Pfizer in District Court of Delaware, alleging infringement of 40 patents, the first US lawsuit involving trastuzumab. 

 

09 Nov 2017 | KR | Samsung Bioepis | Samsung Bioepis announces that Samfenet®, biosimilar trastuzumab is approved by MFDS (South Korea) for the treatment of metastatic breast cancer, early-stage breast cancer and metastatic gastric cancer.  Read more

 

07 Nov 2017 | EU | Mylan/Biocon | Mylan refiles EU applications for biosimilar pegfilgrastim and trastuzumab.  Read more

 

15 Sep 2017 | EU | Samsung Bioepis / MSD | Samsung Bioepis announces it has received positive CHMP opinion on Ontruzant®, biosimilar trastuzumab for early breast cancer, metastatic breast cancer and metastatic gastric cancer.  This is the first biosimilar trastuzumab recommended for EU approval.  Read more

 

10 Sep 2017 | All | Pfizer | Pfizer announces positive findings in pivotal phase 3 study for TmAb candidate PF-05280014 at ESMO 17.  Read more 

 

9 Sep 2017 | All | Amgen/Allergan | Amgen/Allergan present phase 3 data on biosimilar trastuzumab ABP 980 at ESMO 2017.  Read more

 

30 Aug 2017 | US | Mylan/Biocon | FDA extends its decision deadline by 3 months on a s351(k) application for MYL-1401O, Mylan and Biocon’s trastuzumab (Herceptin) biosimilar.  Final decision is now expected by 3 Dec 2017. Read more

 

30 Aug 2017 | US | Samsung Bioepis/Hospira | Samsung Bioepis has filed three petitions seeking joinder with Hospira’s IPR against key Genentech trastuzumab patents (IPR2017-01958 against 6,627,196 patent; IPR2017-01959 against 7,371,379, and  IPR2017-01960 against  7,892,549).  Hospira’s petitions against the same patents (IPR2017-00804, IPR2017-00805, and IPR2017-00737) were instituted by the Board.

 

16 Aug 2017 | EU | Mylan/Biocon | Biocon/Mylan withdraw EU applications for biosimilar trastuzumab & pegfilgrastim.  Read more

 

31 Jul 2017 | US | Amgen/Allergan | Amgen and Allergan announce BLA filing for ABP980, biosimilar trastuzumab.  Read more 

 

31 Jul 2017 | US | Celltrion/ Teva | Celltrion & Teva announce the FDA has accepted for review their BLA for CT-P6, biosimilar Herceptin® (INN: trastuzumab). Read more 

 

27 Jul 2017 | US | Hospira | PTAB instituted IPR on 3 of Hospira’s 5 IPR requests relating to trastuzumab.  The Board instituted IPR of the following patents: 7,371,379 (IPR2017-00805), 6,627,196 (IPR2017-00804), and 7,892,549 (IPR2017-00737). IPR was denied against 7,892,549 (IPR2017-00739) and 7,846,441 (IPR2017-00731).

 

13 Jul 2017 | US | Mylan | Mylan’s biosimilar trastuzumab receives unanimous recommendation for approval by FDA OCAC.  Read more

 

13 Jul 2017 | US | Mylan | Mylan’s biosimilar trastuzumab goes before the FDA Oncology Drugs Advisory Committee in the afternoon session on 13 July 2017 Read more, and receives unanimous recommendation for approval by FDA OCAC.  Read more

 

May 2017 | US | Celltrion/Teva | Celltrion files BLA for Herzuma®, biosimilar trastuzumab, to be marketed by Teva.  Read more

 

13 Mar 2017 | All | Mylan | Mylan announces global settlement with Genentech & Roche on TmAb with global licenses (excluding Japan, Brazil and Mexico).  Read more

 

8 Mar 2017 | EU | Amgen/Allergan |  Amgen announces during a conference presentation that it has filed an application in EMA for biosimilar trastuzumab ABP 980.  Read more  

 

3 Oct 2016 | EU | Samsung Bioepis | Samsung application for SB3, Biosimilar trastuzumab accepted for review by EMA.  Read more

 

 

 

 

 

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Biosimilars Bulletin 

November 9, 2020

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