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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: rituximab

2022

CN | NMPA approves Henlius’ biosimilar rituximab

March 3, 2022

Shanghai Henlius Biotech announced that China’s NMPA has approved its biosimilar rituximab (汉利康®)), as the first biosimilar approved in combination with methotrexate for the treatment of adult patients with rheumatoid arthritis  who have inadequate response to one or more TNF-alpha antagonist therapies.  Additional approved indications include NHL (mono therapy) and CLL in combination with fludarabine and cyclophosphamide.

NZ | NZ’s Pharmac proposes providing access to Riximyo® (biosimilar rituximab) for patients with pemphigus

February 14, 2022

New Zealand’s Pharmac requested feedback on a proposal to provide access to Riximyo® (biosimilar rituximab) for patients with pemphigus.  Riximyo® is not approved for pemphigus in New Zealand and would need to be prescribed by an authorised prescriber in accordance with section 25 of the Medicines Act.  The consultation period closes on 1 March 2022.

2021

New study of belimumab after rituximab in SLE demonstrates promising results

November 24, 2021

A new study of belimumab after rituximab reported a reduction of serum IgG anti-double-stranded DNA antibody levels and the risk for severe flare in systemic lupus erythematosus refractory in comparison to conventional therapy.

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.

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).

Celltrion presents data for Truxima® in patients with DLBCL

June 12, 2021

Celltrion presented data for Truxima® (biosimilar rituximab) in patients with diffuse large B-cell lymphoma at the EHA 2021 Virtual Congress. Celltrion reported that the response rates, survival rates and overall safety profile of Truxima® appeared consistent with those reported for the reference product.

Teva reports its Q1 2021 financial results

April 28, 2021

Teva reported its Q1 2021 financial results.  Teva’s overall year-on-year revenues decreased 10% in local currency terms, but its generic and biosimilar revenues increased 11% year-on-year.  In particular, Truxima® (biosimilar rituximab) was recognised as a key growth driver.

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.

US | Vizient releases Pharmacy Market Outlook

January 27, 2021

Health care performance improvement company Vizient releases its Winter 2021 Pharmacy Market Outlook. Vizient projected that the greatest price increases to members would occur in Humira® (adalimumab), with a 7.5% price increase predicted over the next 18 months. Adalimumab also topped the list of greatest total spend by product among Vizient members, followed by pembrolizumab, rituximab, infliximab, ustekinumab, nivolumab and denosumab. New figures also showed trastuzumab biosimilars have captured a significant market share, contributing to 39% of cost to members in September 2020.

Results of Ph I copanlisib and rituximab trials

January 20, 2021

Targeted Oncology interviews Mark J. Roschewski MD about the preliminary results of Ph II trials of copanlisib and rituximab as treatment of patients with untreated follicular lymphoma. Roschewski reported that all the patients responded and at least had a tumour reduction.

New study investigates use of rituximab in MS

January 8, 2021
A new study reviews the use of rituximab as an alternative treatment option for the management of multiple sclerosis (MS). While not approved for MS, there is evidence of significant off-label usage of rituximab for the treatment of MS in some Northern European countries.

2020

Amgen’s Bourdon provides update on Riabni® (biosimilar rituximab) launch

December 24, 2020
The Centre for Biosimilars interviews Christophe Bourdon, senior VP and general manager of US Oncology at Amgen following FDA approval of Riabni® (biosimilar rituximab). Bourdon stated that Riabni® will be made available through speciality and wholesale distribution, and that Amgen is confident it will be able to support a quick uptake of this biosimilar.

US | FDA approves Riabni®

December 17, 2020

Amgen announces it has received FDA approval for Riabni® (biosimilar rituximab) for the treatment of Non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia, Granulomatosis with Polyangiitis and Microscopic Polyangiitis. Riabni® will be launched in the US in January 2021.

Samsung Biologics and AstraZeneca abandon rituximab JV

November 19, 2020

Korean Biomedical Review reports Samsung Biologics and AstraZeneca will liquidate their joint venture Archigen Biotech and discontinue the development of SAIT101, a rituximab biosimilar. The project was discontinued due to a perceived lack of commercial viability.

Results from new study on Celltrion’s rituximab biosimilar CT-P10 released

October 20, 2020

The American Journal of Managed Care reported a new study indicates Celltrion’s rituximab biosimilar CT-P10 could lower costs and expand patient access to biologic therapy for primary Sjogren syndrome.

EG | Sandoz Egypt partners with the Egyptian Cancer Society

October 20, 2020

Daily News Egypt announces Sandoz Egypt has partnered with the Egyptian Cancer Society to launch a rituximab biosimilar in Egypt. Sameh Elbagoury, Sandoz Country Head for Sandoz Egypt and Libya, announced that the biosimilar could reduce the cost of treating Non-Hodgkin Lymphoma by 40%.

CN | China’s NMPA grants marketing approval for Halpryza®

October 9, 2020

Innovent and Eli Lilly jointly announce China’s NMPA has granted marketing approval for Halpryza® (biosimilar rituximab). Halpryza® is indicated for the treatment of patients with diffuse large b cell lymphoma, follicular lymphoma and chronic lymphocytic leukemia.

Lupus Foundation of Australia reports results from study on rituximab

September 3, 2020

Lupus Foundation of Australia reports a new study demonstrates that rituximab may prove effective as a treatment option for refractory lupus. The study was conducted in 147 people with lupus, and found that six months after the first treatment, 45% of patients demonstrated a complete response to therapy, with another 28% demonstrated some improvement in disease activity.

Results from study of Amgen/Allergan’s proposed rituximab biosimilar released

September 1, 2020

A new study examining the analytical and functional similarity of Amgen/Allergan’s proposed rituximab biosimilar ABP798 concludes that it is highly analytically similar to Rituxan®.

Multiple Sclerosis News Today reports results from study on Ocrevus®

August 26, 2020

Multiple Sclerosis News Today reports a new real-life study demonstrates that Ocrevus® (ocrelizumab) carries a higher risk of infections but carries a lower risk of cancer and immune reactions than rituximab in patients with multiple sclerosis.

CA | Sandoz Canada enters agreement with pCPA regarding Ziextenzo® and Riximyo®

August 19, 2020

Sandoz Canada announces it has entered an agreement with the Pan-Canadian Pharmaceutical Alliance (pCPA) regarding biosimilar medicines Ziextenzo® (biosimilar pegfilgrastim) and Riximyo® (biosimilar rituximab). Both products were approved by Health Canada in late April 2020. Under the pCPA agreement, Riximyo® is reimbursed in Ontario (from July 2020) for certain indications, through Cancer Care Ontario. Additionally, British Columbia announced the reimbursement of Riximyo® (from August 2020) through BC Cancer.

CA | Sandoz Canada enters agreement with pCPA for Ziextenzo® and Riximyo®

August 19, 2020

Sandoz Canada announces it has entered an agreement with the Pan-Canadian Pharmaceutical Alliance (pCPA) regarding biosimilar medicines Ziextenzo® (biosimilar pegfilgrastim) and Riximyo® (biosimilar rituximab). Both products were approved by Health Canada in late April 2020. 

Findings from Sandoz’s REFLECT study of SDX-RTX released

August 7, 2020

OncLive publishes an interview with Manfred Welslau, MD on the findings from the interim results of Sandoz’s REFLECT study of SDX-RTX (rituximab biosimilar). These results reconfirmed the safety and efficacy profile of the product, which has already been approved in the EU, Switzerland, Japan, New Zealand and Australia. Welslau announced that the full results of this study will be released at the end of 2020 or the beginning of 2021.

IN | Cadila Pharmaceuticals launches Ritucad®

July 29, 2020

Cadila Pharmaceuticals announces it has launched Ritucad® (biosimilar rituximab). Ritucad® has been approved for Non-Hodgkin’s Lymphoma and rheumatoid arthritis. This follows Cadila’s launch of Bevaro® (biosimilar bevacizumab) in India last week.

CA | Sandoz anticipates launch of pegfilgrastim and rituximab

July 17, 2020

In an interview with Generics update, Sandoz Canada announces it is aiming for 10 biosimilar launches in the next decade, with pegfilgrastim and rituximab to be launched shortly.

US | Dr Reddy’s Ph III trials progress and anticipates launch

June 28, 2020

Outlook India reports Dr Reddy’s is expecting to launch 25 products in the US market in the current financial year and that Dr Reddy’s Ph III trials of a proposed rituximab biosimilar are progressing as planned.

EU | JP | US | Aptevo Therapeutics announces fixed royalty payments from Pfizer for Ruxience® launch

June 25, 2020

Aptevo Therapeutics announces it will receive quarterly “low single digit” fixed royalty payments from Pfizer (Wyeth) for 7 years from the first launch of Ruxience® (biosimilar rituximab). The original royalty agreement was signed by Trubion Pharmaceuticals which was then acquired by Aptevo’s spin-off Emergent BioSolutions, and Wyeth, in 2016. The royalty is applied to net sales in the US, EU and Japan.

Results from Celltrion Phase II trials of Truxima® released

June 14, 2020

Celltrion presents new data from Phase II trials of a Truxima® (biosimilar rituximab), lenalidomide and acalabrutinib regime for the treatment of relapsed/refractory aggressive B-cell lymphoma. Celltrion reports that the regime was well tolerated by patients.

CA | Health Canada grants marketing approval for Ziextenzo® and Riximyo®

June 9, 2020

Sandoz announces Health Canada has granted marketing approval for Ziextenzo® (pegfilgrastim) and Riximyo® (rituximab).

CA | Sandoz granted marketing approval for Ziextenzo® and Riximyo®

June 9, 2020

Sandoz announces Health Canada has granted marketing approval for Ziextenzo® (pegfilgrastim) and Riximyo® (rituximab).

Celltrion’s Truxima® certified in WHO prequalification program

May 28, 2020

The WHO certifies Celltrion’s Truxima® (rituximab) in its prequalification program. This program assesses clinical and other data related to biosimilars, and aims to guide low-income countries in their selection of medicines, vaccines and technologies for national procurement.

US | The American Journal of Managed Care report released

May 26, 2020

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.

US | Teva and Celltrion announce launch of Truxima®

May 4, 2020

Teva and Celltrion announce the launch of Truxima® in the US. Truxima® is indicated for the treatment of rheumatoid arthritis, granulomatosis with polyangiitis and miscroscopic polyangiitis, making it the only approved biosimilar with the same indications as Rituxan®.

EU | EC approves of Ruxience® for treatment

April 2, 2020

Pfizer announces EC approval of Ruxience® for the treatment of non-hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris.

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.

iBio and AzarGen Biotechnologies enter second Statement of Work

March 26, 2020

iBio and AzarGen Biotechnologies announce they have entered into a second Statement of Work under their Master Joint Development Agreement. Under this agreement, iBio will assist AzarGen in the manufacture and characterisation of supplies to enable pre-clinical studies of a rituximab biosimilar.

Results of study on Truxima® released

March 17, 2020

A new study reports that Truxima®  is comparable to the originator in terms of efficacy and safety in the treatment of multiple sclerosis.

EU | CHMP releases opinion for Ruxience®

January 31, 2020

Pfizer announces positive CHMP opinion for Ruxience® .

US | Pfizer launches Ruxience®

January 23, 2020

Pfizer launches Ruxience® in the US at a 24% discount to Rituxan®.

US | Coherus acquires commercialisation rights to rituximab biosimilar

January 13, 2020

Coherus exercises option under agreement with Innovent to acquire commercialisation rights to rituximab biosimilar in the US.

2019

US | Amgen submits BLA to FDA

December 19, 2019

Amgen submits BLA for biosimilar rituximab to FDA. 

Celltrion Ph III trials of Truxima® released

December 9, 2019

Celltrion releases results of Ph III trials of Truxima® at the American Society of Hematology, announcing it was non inferior to Rituxan® in terms of efficacy and safety.

Teva and Celltrion’s discounted Truxima® is launched

November 7, 2019

Teva and Celltrion announce launch of Truxima® in the US, at a 10% price reduction compared to Rituxan®.

Henlius Biotech’s biosimilar rituximab recognised

November 6, 2019

Henlius Biotech wins ‘Biosimilar Initiative of the Year’ for its biosimilar rituximab at the Global Generics and Biosimilars Awards.

Archigen Biotech fails to develop Rituxan biosimilar

October 16, 2019

Samsung executives admit subsidiary Archigen Biotech failed to develop a Rituxan biosimilar. The admission was made in Korean court court proceedings, with 8 executives and employees of Samsung facing accounting fraud charges.

Results from Phase III clinical trials of MabThera/Rituxan® released

October 14, 2019

Roche announces results of Phase III clinical trials of MabThera/Rituxan® compared to mycophenolate mofetil (MMF) in adults with moderate to severe pemphigus vulgaris (PV). Roche has announced that the results demonstrate Rituxan’s superiority over MMF for PV patients.

Report on Unsupported Price Increases regarding Roche’s Rituxan® released

October 8, 2019

The Institute for Clinical and Economic Review releases its report on Unsupported Price Increases, highlighting Roche’s Rituxan® as one of the products with price increases which are unsupported by new clinical evidence. 

Dr Reddy’s Ph III trials of biosimilar rituximab commence

September 19, 2019

Dr Reddy’s commences enrolment for Phase III trials of biosimilar rituximab

iBio enters initial “Statement of Work”

September 18, 2019

iBio announces it has entered into an initial “Statement of Work” under its MOU with AzarGen Biotechnologies. iBio will manufacture research quantities of a plant-made rituximab using iBio’s proprietary FastPharming™ System.

Results of comparative clinical study into Amgen rituximab biosimilar candicate released

August 22, 2019

Amgen presents results of clinical study comparing safety and efficacy of rituximab biosimilar candidate to originator, reporting clinical equivalence.

AU | Celltrion anticipates launch of biosimilar products

August 14, 2019

Celltrion remains optimistic ahead of Truxima® launch, despite difficulty with biosimilar uptake in Australian market. Expanding its Australian office from 4 to 15 people, the company is hoping to launch 3 biosimilar products in Australia in the next 3 years, including Truxima® and Herzuma®.

US | FDA approves Ruxience® for treatment

July 23, 2019

Pfizer announces FDA approval for rituximab biosimilar rituximab (Ruxience®) for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis. This is the second biosimilar RmAb approved in the US, following the approval of Celltrion’s Truxima in November 2018.

CN | Celltrion announces creation of JVCo for commercialisation

July 18, 2019

Celltrion announces creation of JVCo with Nan Fung Group for the commercialisation of Remsima®, Truxima® and Herzuma® in China. The joint venture company, Vcell Healthcare will obtain exclusive rights to develop, manufacture and commercialise these three products in mainland China.

Study results for mAbxienxe’s biosimilar rituximab

July 11, 2019

Study finds mAbxienxe’s biosimilar rituximab candidate RTXM83 is not inferior to the reference drug in terms of efficacy.

Study results into efficacy of rituximab released

July 7, 2019

A new study reveals rituximab may be effective in managing mixed cryoglobulinemic vasculitis.

US | Roche’s BLA accepted and Rituxan® under review

June 12, 2019

FDA accepts Roche’s BLA and grants priority review to Rituxan® for the treatment of granulomatosis with polyangiitis and microscopic polyangiitis in children. The FDA is yet to approve any treatments for these blood vessel disorders.

JA | Genentech’s infringement suit against Sandoz dismissed

May 29, 2019

Tokyo District Court judge dismisses Genentech’s infringement suit against Sandoz and its local marketing partner Kyowa Hakko Kirin.

Results of Phase III clinical trials of rituximab biosimilar released

May 9, 2019

Innovent and Eli Lilly announce rituximab biosimilar IBI301 met primary endpoints in Phase III clinical trials and PK study.

AU | Sandoz and Roche settle dispute over rituximab biosimilar

April 11, 2019

Sandoz and Roche settle long-running AU Federal Court dispute over rituximab biosimilar, allowing for the launch of Sandoz product Riximyo® “in the near future”.  The 2017 Federal Court proceedings before Burnley J were dismissed.

CA | Teva’s Truxima® approved by Health Canada

April 10, 2019

Health Canada approves Teva’s Truxima® for the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis in adult patients.

AU | Celltrion biosimilar products recommended for PBS listing

March 16, 2019

PBAC Committee recommends all 4 brands of Celltrion biosimilar products (Tuxella®, Rituzena®, Ritemvia®, Truxima) for PBS listing in AU for all TGA registered indications for which the reference brand Mabthera is currently listed on the PBS, despite approved skinny label). 

EU | EC approves label expansion of MabThera®

March 15, 2019

Roche announces EC approval for a label expansion of MabThera®. The approval now includes the treatment of pemphigus vulgaris, the first major advancement for the treatment of this disease in more than 60 years.

AU | Celltrion Rituzena® and Tuxella® approved

March 1, 2019

Celltrion gains Australian approval for biosimilar rituximab under two product names, Rituzena® and Tuxella®.

CN | Hanlikon® is approved

February 25, 2019

China’s National Medical Products Administration approves first rituximab biosimilar, Hanlikon®.

US | Results of Phase I/Phase III study of rituximab biosimilar released

January 24, 2019

Amgen announces results of Phase 1/Phase 3 study of rituximab biosimilar candidate, confirming the study demonstrated favourable efficacy and safety profiles.

Samsung Biogen’s patent for biosimilar rituximab invalidated

January 18, 2019

Celltrion announces success in litigation against Samsung Biogen, invalidating Samsung Biogen’s patent for biosimilar rituximab. 

2018

JHL commences randomised Phase III study in China

December 27, 2018

JHL announces first patient in randomised Phase III study conducted in China. The trial is being conducted in patients with previously untreated diffuse large B-cell lymphoma.

US | Results from study into Celltrion’s Truxima® released

December 14, 2018

Results of two year study demonstrate similar safety and efficacy between Celltrion’s Truxima® and the reference product in the treatment of advanced follicular lymphoma.

EU | Results of Sandoz’s proposed RmAB biosimilar released

December 1, 2018

At the ASH Annual meeting, a paper was presented indicating positive results for Sandoz’s proposed RmAb biosimilar to EU reference drug, and concluding “efficacy, safety and immunogenicity, PK and PD of PF‑05280586 and rituximab-EU were similar up to Week 26 in subjects with previously untreated CD20-positive, LTB-FL”

US | FDA approves Celltrion’s Truxima® as treatment

November 28, 2018

FDA approves Celltrion’s rituximab biosimilar CTP-10 (Truxima®), for the treatment of non-Hodgkin’s lymphoma. This is the first US biosimilar RmAb to be approved.

AU | Sandoz rituximab biosimilar approved

November 16, 2018

Sandoz receives approval for rituximab biosimilar under two presentations and two brands. The approval includes 500mg/50mL Rixonfya®, 100mg/10 mL Rixonfya®, 500mg/50mL Rixvyda® and 100mg/10mL Rixvyda®. Sandoz is currently prevented from supplying for use, selling, supplying or offering to sell biosimilar rituximab (under injunction) until 11 August 2019, with a Federal Court hearing set down for 3 weeks beginning on 3 June 2019.

US | Sandoz announces withdrawal of biosimilar rituximab

November 2, 2018

Sandoz announces it will not pursue biosimilar rituximab in the US following requests from the FDA for additional information to complement the BLA.

US | Genentech announces expanded indication set

October 19, 2018

In advance of US biosimilar competition, Genentech announces expanded indication set, including follow up treatment in adult patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) who have achieved disease control with induction treatment.

US | Celltrion CT-P10 recommended for approval

October 10, 2018

US’ Oncologic Drug Advisory Committee unanimously recommends Celltrion’s CT-P10 for approval as a biosimilar to Rituxan.

US | Merck secures development deal to supply rituximab biosimilar

October 7, 2018

Merck secures 5 year, $117.5M deal with US Department of Veterans Affairs to supply rituximab biosimilar developed by Samsung.

EU | AryoGen granted GMP certification

September 3, 2018

Iranian AryoGen receives GMP certification from the European Medicines Agency, becoming the first mAb manufacturer in the Middle East and North Africa region to do so. 

CN | iBio and CC-Pharming enter marketing agreement

August 7, 2018

iBio and CC-Pharming enter agreement to develop biosimilar rituxumab for the Chinese market.

US | Celltrion resubmits aBLA for biosimilar Rituxan®

May 30, 2018

Celltrion resubmits its aBLA for CT-P10 (rituximab) biosimilar Rituxan®.  According to Celltrion, the FDA has resumed the approval procedure and Celltrion expects approval in 2018.

US | FDA rejects Celltrion BLA for biosimilars to trastuzumab and rituximab

May 4, 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.

US | Sandoz announces FDA rejection of BLA for biosimilar rituximab

May 2, 2018

Sandoz announces that the FDA has provided a CRL rejecting its BLA for biosimilar rituximab.

AU | Celltrion’s Truxima® approved by TGA

April 14, 2018

Celltrion’s rituximab biosimilar Truxima® is approved by the TGA. This is the second biosimilar approved in 4 months, following the approval of Sandoz’s Riximyo™ in December 2017.

TR | TRpharm reveals anticipation of biosimilar rituximab launch

March 14, 2018

TRpharm announces it is ready to launch biosimilar rituximab (developed by Dr Reddy’s) in Turkey, following approval on 30 Jan 2018.

Pfizer releases results for PF-05280586

January 24, 2018

Pfizer announces positive top line results for PF-05280586, biosimilar to Rituxan/MabThera.

JP | Genentech sues Sandoz and Kyowa Hakko Kirin

January 14, 2018

Genentech has sued Sandoz and Kyowa Hakko Kirin (Sandoz’s exclusive distributor) in Japan, alleging the sale of biosimilar RmAb (Rixathon®/Riximyo®) infringes 3 Genentech patents. Rixathon®/Riximyo® was approved in JP in Sep 2017.

US | Teva and Celltrion file DJ action against rituximab patents

January 11, 2018

Teva and Celltrion file DJ action in the District Court (Northern District of California) against 37 rituximab patents alleging they are invalid, unenforceable and/or not-infringed. FDA accepted Celltrion’s ABLA on 27 June 2017, and the parties entered a patent dance.  On the same day, parallel proceedings were also filed in the same Court relating to (some overlapping) 38 patents to trastuzumab.

2017

AU | Roche sues Sandoz for Riximyo®

December 21, 2017

Roche has sued Sandoz in the Federal Court in Sydney over its recent approval of Riximyo®, alleging infringement of 5 patents: AU2008207357, 761844, 2005211669, 2009201403, and 2007242919.

AU | Sandoz’s Riximyo® approved in Australia

November 30, 2017

Sandoz’s biosimilar rituximab, Riximyo® approved in Australia, following its approval in Europe 5 months earlier.

RU | Biocad succeeds in rituximab patent challenge

October 27, 2017

Russian biosimilars company Biocad succeeds in Russian patent challenge relating to the use of rituximab for RA, and announces intention to launch in EU.

US | Sandoz’s application for rituximab accepted

September 12, 2017

FDA accepts Sandoz’s s351(k) application for rituximab.

EU | Celltrion and Mundipharma disclose financial impact of Truxima®

August 1, 2017

Celltrion/Mundipharma claim their biosimilar rituximab (Truxima®) has 30% of total EU market due to rapid growth.

US | Teva/Celltrion’s aBLA accepted

June 29, 2017

FDA accepted Teva/Celltrion’s aBLA for CT-P10, biosimilar rituximab.

EU | EU approves Sandoz’s Rixathon®

June 19, 2017

EU approval received for Sandoz’s Rixathon® (biosimilar rituximab) to treat blood cancers and immunological diseases.

EU | Mundi’s Truxima® approved by EMA

February 22, 2017

Mundi’s biosimilar rituximab (Truxima®, developed by Celltrion) approved by EMA, and intended for launch in the UK, Germany, Italy, Netherlands, Belgium, Ireland and Luxembourg.

2016

CA | US | Teva and Celltrion enter marketing deal for commercialisation

October 6, 2016

Teva and Celltrion announce exclusive marketing deal under which Teva will commercialise Celltrion’s biosimilar rituximab and trastuzumab products in the US and CA.

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 March 3, 2022