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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: trastuzumab

2022

Amgen publishes its Q1 2022 financial results

April 27, 2022

Amgen released its Q1 2022 financial results, reporting a 6% increase in YoY revenues. Amgen reported a 12% increase in Prolia® (denosumab) sales, a 7% decrease in Enbrel® (etanercept) sales, a 2% increase in Amgevita™ (biosimilar adalimumab) sales and a 40% decrease in Kanjinti® (biosimilar trastuzumab) sales.

Samsung Bioepis secured 10 biosimilar products on its 10th year anniversary

February 28, 2022

The Korea Herald reported that Samsung Bioepis has secured a total of 10 biosimilar products on its 10th year anniversary.  Six biosimilars have been approved globally: infliximab, etanercept, adalimumab, trastuzumab, bevacizumab and ranibizumab.  Eculizumab has recently completed its Ph III clinical trial, and three other biosimilar candidates are under Ph III trials.

EU | Prestige BioPharma receives EUGMP certification for Tuznue® (biosimilar trastuzumab) manufacturing facility

February 21, 2022

Prestige BioPharma announced that the manufacturing facility for Tuznue® (biosimilar trastuzumab) has received EUGMP certification.  Tuznue® is under Marketing Authorisation Application review in the EU, Canada and South Korea.

ZA | South Africa’s Competition Commission to prosecute Roche over trastuzumab product

February 8, 2022

South Africa’s Competition Commission filed a referral with the Competition Tribunal for prosecution of Roche for alleged excessive pricing of trastuzumab.

CA | Health Canada approves Ontruzant® (biosimilar trastuzumab)

February 2, 2022

Samsung Bioepis announced that Health Canada has approved Ontruzant® (biosimilar trastuzumab) for the treatment of adults with early breast cancer, metastatic breast cancer and metastatic gastric cancer.

2021

EU | Sandoz submits BLA to EMA for proposed biosimilar trastuzumab

December 22, 2021

Sandoz announced that it has submitted a BLA to the EMA for a proposed biosimilar trastuzumab.

US | Sandoz submits BLA for proposed biosimilar trastuzumab

December 20, 2021

Sandoz announced that it has submitted a BLA to the FDA for a proposed biosimilar trastuzumab.

Dr Reddy’s and Prestige BioPharma enter into trastuzumab agreement

December 9, 2021

Dr Reddy’s and Prestige BioPharma announced that they have entered into an exclusive partnership for the supply and commercialisation of Prestige BioPharma’s proposed trastuzumab biosimilar in select countries in Latin America and Southeast Asia.

Samsung Bioepis publishes five-year follow-up results of Ontruzant® (biosimilar trastuzumab)

December 8, 2021

Samsung Bioepis announced that its Ontruzant® (biosimilar trastuzumab) demonstrated comparable long-term survival results with reference trastuzumab in five-year follow-up results.

Celltrion provides update on biosimilars pipeline

November 10, 2021

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.

Samsung Bioepis releases new data on five-year follow-up study of Ontruzant® (trastuzumab biosimilar)

September 13, 2021

Samsung Bioepis reported on a five-year follow-up study comparing ONTRUZANT® (trastuzumab biosimilar) with reference trastuzumab in early or locally advanced HER2 positive breast cancer. Samsung Bioepis reported that five year survival rates were 93.1% in the biosimilar trastuzumab group compared with 86.7% in the reference medicine group.

JP | Celltrion’s Herzuma® captures 51% of Japanese market

August 11, 2021

Celltrion announced that Herzuma® (biosimilar trastuzumab) gained 51% of the market share in Japan in June.

New study reports on ABP980 and pertuzumab administered as an admixture

August 5, 2021

A new study reported that the safety profiles and pharmacokinetic parameters of Amgen’s ABP980 (biosimilar trastuzumab) and pertuzumab administered as an admixture in a single infusion bag is consistent with what is known for reference trastuzumab and pertuzumab.

Amgen released its Q2 2021 financial results

August 3, 2021

Amgen released its Q2 2021 financial results, reporting double digit volume growth for Prolia® (denosumab), Repatha® (evolocumab), Mvasi® (biosimilar bevacizumab) and Kanjinti® (biosimilar trastuzumab).

BR | Celltrion wins tender to supply Brazilian market with trastuzumab and rituximab

August 3, 2021

Celltrion announced it has won a tender to supply the Brazilian market with Herzuma® (biosimilar trastuzumab) and Truxima® (biosimilar rituximab).

Prestige BioPharma trastuzumab biosimilar demonstrates equivalent pharmacokinetic and safety profile to reference trastuzumab

July 28, 2021

Prestige BioPharma announced that HD201 (proposed trastuzumab biosimilar) demonstrated an equivalent pharmacokinetic and safety profile to reference trastuzumab in a bridging study completed last year.

IN | Zydus Cadila launches trastuzumab emtansine in India

May 24, 2021

Zydus Cadila announced it has launched Ujvira (trastuzumab emtansine) in India. Ujvira is an antibody drug conjugate biosimilar and is available in 100mg and 160mg vials at a considerable discount to the reference product.

Prestige BioPharma announces new deal with Busan City Government

May 18, 2021

Prestige BioPharma announced it has entered into a memorandum of understanding with the Busan City Government for the establishment of a R&D centre in Busan, South Korea.  Prestige announced that the 45,000 m2 centre will house 209 new R&D personnel for the next five years.  Prestige also announced that it has completed Ph III trials of its proposed trastuzumab biosimilar, and an application is currently under EMA review.

Biocon reports its Q1 2021 financial results

April 29, 2021

Biocon reported its Q1 2021 financial results.  Biocon reported its biosimilars revenues increased 53% year-on-year.  Biocon identified its pegfilgrastim and trastuzumab biosimilars as key growth drivers.

Roche published Q1 2021 earnings report

April 21, 2021

Roche published its Q1 2021 earnings report, noting significant impacts from biosimilars. In particular, Roche attributed a combined sales reduction of CHF 1.6 billion to the impact of rituximab, bevacizumab and trastuzumab biosimilars.

EirGenix announced positive Ph III results for trastuzumab biosimilar

March 24, 2021

EirGenix announced that its Ph III clinical trial of EG12014 (proposed trastuzumab biosimilar) has met its primary endpoint. EirGenix announced that EG12014 has shown equivalent efficacy to Herceptin®, and demonstrated a comparable safety profile.

JP | Herzuma® gains 44% market share in Japan

March 17, 2021

The Korea Herald reported that Celltrion’s Herzuma® (biosimilar trastuzumab) reached a 44% market share in Japan last year.

MENA | Tabuk partners with Prestige on Tuznue®(biosimilar trastuzumab)

February 13, 2021

Saudi Arabia’s Tabuk Pharmaceuticals announced it has reached an exclusive licensing and distribution agreement with Korea’s Prestige Biopharma for the commercialisation of Tuznue® (biosimilar trastuzumab). Under the agreement, Tabuk will receive exclusive rights to commercialise and distribute Tuznue® in the Middle-East and North Africa region.

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%.

EU | Strong uptake of Amgen’s Kanjinti® (biosimilar trastuzumab) in Europe

January 5, 2021
The Centre for Biosimilars reported a study presented at the 2020 San Antonio Breast Cancer Symposium found strong uptake of Amgen’s Kanjinti® (biosimilar trastuzumab) in Europe.

2020

US | New study demonstrates increased usage of trastuzumab biosimilars

December 16, 2020

The Centre for Biosimilars reports a new study indicates dramatically increased usage of trastuzumab biosimilars in the US. The study presented at the San Antonio Breast Cancer Symposium indicated that biosimilar use increased based on payer policies that favored biosimilars.

Prestige BioPharma and Teva Israel exclusive partnership and supply agreement for Prestige’s Tuznue®

November 10, 2020

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.

BR | Celltrio signs contract to provide Herzuma® and Truxima® to Brazilian Federal Government

October 13, 2020

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.

Results from Centre for Biosimilars studies for HD201 released

October 13, 2020

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.

UK | Accord Healthcare launches Zercepac® in UK

September 24, 2020

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.

CN | Shanghai Henlius Biotech trastuzumab biosimilar Zercepac® approved

August 14, 2020

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.

BR | Samsung Bioepis launches Ontruzant®

August 10, 2020

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.

Celltrion trastuzumab biosimilar Herzuma® gains WHO prequalification

August 3, 2020

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.

EU | Shanghai Henlius Biotech and Accord Healthcare announce EC approval of Zercepac®

July 29, 2020

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.

Results from study on Herzuma® released by Journal of Clinical Pathways

July 8, 2020

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.

US | Genentech and Amgen file stipulations for dismissal of BPCIA litigation

July 7, 2020

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.

EU | CHMP recommends marketing authorisation for Henlius Biotech HLX02

May 31, 2020

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

CN | Henlius Biotech adalimumab and trastuzumab under New Drug Application review

May 27, 2020

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

Results from Samsung Bioepis study on Ontruzant® released

May 15, 2020

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.

Biocon manufacturing practice compliance recognised

May 12, 2020

Biocon receives good manufacturing practice compliance certificate from the EMA for Bengaluru facilities.

EU | Henlius Biotech receives EU GMP certificates for trastuzumab biosimilar

April 23, 2020

Henlius Biotech announces it has received two EU GMP certificates related to its trastuzumab biosimilar HLX02.

US | Merck and Samsung Bioepis Ontruzant® launches in the US

April 15, 2020

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.

BA | Biocad receives registration certificates for Acellbia® and Herticad®

March 30, 2020

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

US | FDA approves Samsung Bioepis mutli-dose vial Ontruzant®

March 24, 2020

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

US | Teva and Celltrion launch Herzuma®

March 16, 2020

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.

US | Refusal of Amgen preliminary injunct for biosimilar trastuzumab affirmed

March 9, 2020

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.

US | Pfizer anticipates biosimilar TmAb Trazimera® launch

January 23, 2020

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

HK | TW | Mundipharma enters exclusive commercialisation agreement with Samsung

January 13, 2020

Mundipharma announces commercialisation agreement with Samsung. The agreement grants Mundipharma exclusive commercialisation rights to Samsung’s adalimumab, etanercept, trastuzumab and bevacizumab candidates in Taiwan and Hong Kong.

2019

CN | AffaMed Ph III trials of Samsung’s trastuzumab biosimilar approved

December 10, 2019

AffaMed receives Chinese approval to commence Ph III trials of Samsung’s trastuzumab biosimilar SB3.

Results of NeuClone Ph I trials of trastuzumab biosimilar released

December 5, 2019

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

US | Mylan and Biocon launch Ogivri® in US

December 2, 2019

Mylan and Biocon announce the launch of Ogivri® in the US.

Shanghai Henlius Phase III clinical trial results released

November 26, 2019

Shanghai Henlius announces proposed trastuzumab biosimilar met primary endpoint in Phase III clinical trials.

Celltrion and Juno enter co-marketing partnership agreement for Herzuma® and Truxima®

October 3, 2019

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.

CA | Celltrion biosimilar trastuzumab approved for treatment

September 11, 2019

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.

JHL ceases development and clinical trials for settlement deal with Genentech

September 9, 2019

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.

JA | Celltrion Herzuma® approved in Japan

August 22, 2019

Celltrion announces Japanese approval for three-week cycle of Herzuma® for the treatment of breast cancer.

AU | Mylan and Biocon Ogivri® launches in Australia

August 1, 2019

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.

AU | Amgen and Celltrion biosimilar trastuzumab products considered for PBS listing

July 19, 2019

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.

US | Genentech request for injunction against Amgen rejected

July 18, 2019

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.

CN | Celltrion JV Co created for commercialisation of Remsima®, Truxima® and Herzuma®

July 18, 2019

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.

US | Samsung and Genentech Ontruzant® patent dispute settles

July 4, 2019

Samsung and Genentech settle patent dispute, allowing for the sale of Samsung’s Ontruzant®.

Prestige enters agreements with Pharmapark and Munipharma for Tuznue®

July 2, 2019

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.

EU | EMA accepts Henlius’ MAA for trastuzumab biosimilar HLX02

June 21, 2019

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.

US | Amgen biosimilar TmAb Kanjinti® approved

June 13, 2019

FDA approves Amgen’s biosimilar TmAb Kanjinti® for all indications.

EU | Prestige Biopharma’s application for Tuznue® accepted

May 28, 2019

The EMA accepts Prestige Biopharma’s application for trastuzumab biosimilar Tuznue®.

CA | Ogivri® approved by Health Canada for treatment of breast cancer and metastatic stomach cancer

May 22, 2019

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.

AU | Amgen biosimilar trastuzumab Kanjinti® approved

May 16, 2019

Amgen receives Australian approval for biosimilar trastuzumab Kanjinti®, in 60mg, 150mg and 420mg dosages.

US | FDA approves Pfizer biosimilar trastuzumab Trazimera® for treatment

March 11, 2019

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

US | Subcutaneous formulation of Herceptin approved for treatment of HER2-overexpressing breast cancer

February 28, 2019

FDA approves subcutaneous formulation of Herceptin for the treatment of HER2-overexpressing breast cancer.

Samsung Bioepis enters commercialisation partnership with C-Bridge

February 26, 2019

Samsung Bioepis partners 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.

Samsung Bioepis enters partnership with C-Bridge for trastuzumab biosimilars

February 11, 2019

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.

US | FD approves Samsung Bioepis biosimilar trastuzumab

January 21, 2019

FDA approves biosimilar trastuzumab for all eligible indications. This is Samsung Bioepis’ first oncology biosimilar to receive FDA approval.

AU | Samsung Bioepis biosimilar trastuzumab Ontruzant® approved

January 9, 2019

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.

2018

Shanghai Henlius’ results from TmAb Phase III trials released

December 23, 2018

Shanghai Henlius’ research team presented an update on its TmAb clinical program with Phase III trials underway in Poland, Ukraine, Phillippines and China.

Prestige enters licensing agreement with Cipla

December 23, 2018

Prestige announces licensing agreement with Cipla, granting Cipla exclusive rights to distribute and market Prestige’s TmAb biosimilar in emerging markets.

EU | Biocon biosimilar trastuzumub (Ogivri®) market authorised

December 20, 2018

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.

US | TmAb biosimilar FDA approved for treatment of HER2-positive breast cancer

December 20, 2018

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.

Genentech and Pfizer dismisses claims in litigation

December 13, 2018

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.

AU | Alphapharm Ogivri® receives TGA approval in Australia

December 11, 2018

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.

US | Results from follow-up study on Samsung Bioepis trastuzumab released

December 8, 2018

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

JP | First trastuzumab biosimilar launches in Japan

November 28, 2018

Daiichi Sankyo launches first trastuzumab biosimilar in Japan.

NeuClone clinical trials for biosimilar trastuzumab commence

October 23, 2018

NeuClone commences Phase I clinical trials for biosimilar trastuzumab.

EU | CHMP recommends Mylan and Biocon’s Ogivri® for approval

October 19, 2018

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.

JP | Celltrion’s trastuzumab biosimilar launches in Japan

August 20, 2018

Nippon Kayaku launches Celltrion’s trastuzumab biosimilar in Japan, but only for the treatment of gastric cancers.

EU | EMA approves of Pfizer biosimilar trastuzumab, Trazimera®

July 31, 2018

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.

IN | Dr Reddy’s biosimilar trastuzumab launches in India

July 26, 2018

Dr Reddy’s announces biosimilar trastuzumab available in India for the treatment of HER2-positive cancers.

AU | Celltrion biosimilar TmAb products approved in Australia

July 17, 2018

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.

EU | Biocon receives EU CGMP certification for Bangalore facility

July 4, 2018

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

EU | Prestige and Alvogen enter partnership to commercialise Hervelous®

June 28, 2018

Prestige and Alvogen announce partnership to commercialise Prestige’s trastuzumab biosimilar, Hervelous®, in Central and Eastern Europe.

US | Celltrion resubmits application for marketing approval of trastuzumab biosimilar

June 17, 2018

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.

US | FDA rejects Amgen’s application for biosimilar trastuzumab ABP 980

June 1, 2018

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.”

EU | Pfizer’s Trazimera® recommended for marketing authorisation by CHMP

June 1, 2018

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

US | Celltrion announces intentions to refile aBLA for CT-P6 (trastuzumab)

May 30, 2018

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

EU | Mundipharma biosimilar trastuzumab launches in Europe

May 2, 2018

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.

US | CRL from FDA for Pfizer biosimilar trastuzumab released

April 23, 2018

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.

US | FDA rejects Celltrion BLA for biosimilars to trastuzumab (CT-P6) and rituximab (CT-P10)

April 6, 2018

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.

EU | EMA’s CHMP adopts positive opinion for Amgen/Allergan’s trastuzumab biosimilar Kanjinti®

March 22, 2018

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.

EU | Mundi and Celltrion enter distribution and marketing agreement for Herzuma®

March 19, 2018

Mundi and Celltrion enter exclusive distribution and marketing agreement for biosimilar trastuzumab, Herzuma®, for 7 EU countries including UK, DE and IT.

EU | Ontruzant® launched as first TmAb biosimilar in Europe

March 9, 2018

Merck launches the first TmAb biosimilar in Europe by selling the product developed by Samsung Bioepis (SB3) as Ontruzant® in the UK.

EU | Celltrion’s Herzuma® approved by EC

February 13, 2018

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.

US | Celltrion and Teva commence proceedings for trastuzumab patents

January 19, 2018

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”.

2017

US | Mylan/Biocon trastuzumab biosimilar Ogivri® approved

December 3, 2017

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.

EU | Samsung Bioepis receives regulatory approval for Ontruzant®

November 19, 2017

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.

US | Roche sues Pfizer for trastuzumab

November 17, 2017

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

KR | Samsung Bioepis Samfenet® approved by MFDS for treatment

November 9, 2017

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.

EU | Mylan refiles EU applications

November 7, 2017

Mylan refiles EU applications for biosimilar pegfilgrastim and trastuzumab.

EU | Samsung Bioepis receives positive CHMP opinion on Ontruzant®

September 15, 2017

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.

Pfizer Phase III study for TmAb candidate announced

September 9, 2017

Pfizer announces positive findings in pivotal Phase III study for TmAb candidate PF-05280014 at ESMO 17.

Phase III data on Amgen/Allergan biosimilar trastuzumab released

September 9, 2017

Amgen/Allergan present Phase III data on biosimilar trastuzumab ABP 980 at ESMO 2017.

US | FDA extends deadline on application for Mylan/Biocon trastuzumab biosimilar

September 2, 2017

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.

US | Samsung Bioepis files petitions against Genentech trastuzumab patents

August 30, 2017

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.

EU | Biocon/Mylan withdraw EU applications

August 16, 2017

Biocon/Mylan withdraw EU applications for biosimilar trastuzumab & pegfilgrastim.

US | Amgen and Allergan files BLA for biosimilar trastuzumab

July 31, 2017

Amgen and Allergan announce BLA filing for ABP980, biosimilar trastuzumab.

US | FDA reviews Celltrion & Teva BLA for biosimilar Herceptin®

July 31, 2017

Celltrion & Teva announce the FDA has accepted for review their BLA for CT-P6, biosimilar Herceptin® (INN: trastuzumab).

US | PTAB institutes IPR on Hospira requests for trastuzumab

July 27, 2017

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).

US | Mylan’s biosimilar trastuzumab recommended for FDA OCAC approval

July 13, 2017

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

US | Celltrion files BLA for Herzuma®

May 24, 2017

Celltrion files BLA for Herzuma®, biosimilar trastuzumab, to be marketed by Teva.

EU | Amgen files application for biosimilar trastuzumab

March 24, 2017

Amgen announces during a conference presentation that it has filed an application in EMA for biosimilar trastuzumab ABP 980.

Mylan enters global settlement with Genentech & Roche

March 14, 2017

Mylan announces global settlement with Genentech & Roche on TmAb with global licenses (excluding Japan, Brazil and Mexico).

2016

EU | Samsung biosimilar trastuzumab under review

October 3, 2016

Samsung application for SB3, biosimilar trastuzumab accepted for review by EMA.

2011

EU | Stada and Richter reveal collaboration deals for marketing

September 2, 2011

Stada and Gedeon Richter announce collaboration deals to develop and sell biosimilars rituximab and trastuzumab.

BioBlast® extract From September 2, 2011 to April 27, 2022