Rituxan®/MabThera® | Rituximab | Genentech/Biogen

20 Oct 20 | All | Celltrion | 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.

 

20 Oct 20 | EG | Sandoz | 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%.

 

09 Oct 20 | CN | Innovent, Eli Lilly | 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.

 

03 Sep 20 | All | All | 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.

 

01 Sep 20 | All | Amgen, Allergan | 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®.

 

26 Aug 20 | All | All | 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.

 

19 Aug 20 | CA | Sandoz | 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.

 

07 Aug 2020 | All | Sandoz | 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.

 

30 Jul 2020 | IN | Cadila Pharmaceuticals | 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.

 

17 Jul 2020 | CA | Sandoz | In an interview with Generics Bulletin, Sandoz Canada announces it is aiming for 10 biosimilar launches in the next decade, with pegfilgrastim and rituximab to be launched shortly.

 

28 June 2020 | US | Dr Reddy's | 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.

 

25 Jun 2020 | US, EU, JP | Aptevo, Pfizer | 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.

 

14 Jun 2020 | All | Celltrion | 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.

 

09 Jun 2020 | CA | Sandoz | Sandoz announces Health Canada has granted marketing approval for Ziextenzo® (pegfilgrastim) and Riximyo® (rituximab).

 

28 May 2020 | All | Celltrion | 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.

 

25 May 2020 | US | Pfizer | The American Journal of Managed Care reports two cost savings studies presented at a virtual meeting of the International Society for Pharmacoeconomics and Outcomes Research. The studies, which were sponsored by Pfizer, analysed the potential cost savings over a three year period from a US perspective in switching to bevacizumab and rituximab biosimilars. The studies concluded that over three years $14.7 million could be saved on bevacizumab used to treat 503-676 patients, with $3.8 million saved on rituximab used to treat 754-764 patients.

 

04 May 2020 | US | Teva, Celltrion | 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®.

 

02 Apr 2020 | EU | Pfizer | 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.

 

01 Apr 2020 | All | A new study reports that Truxima®  is comparable to the originator in terms of efficacy and safety in the treatment of multiple sclerosis.

 

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.

 

26 Mar 2020 | All | iBio, AzarGen | 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.

 

31 Jan 2020 | EU | Pfizer | Pfizer announces positive CHMP opinion for Ruxience® .

 

23 Jan 2020 | US | Pfizer | Pfizer launches Ruxience® in the US at a 24% discount to Rituxan®.

 

13 Jan 2020 | US | Coherus, Innovent | Coherus exercises option under agreement with Innovent to acquire commercialisation rights to rituximab biosimilar in the US.

 

19 Dec 2019 | US | Amgen | Amgen submits BLA for biosimilar rituximab to FDA.  

 

09 Nov 2019 | All | Celltrion | 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.

 

07 Nov 2019 | All | Teva, Celltrion | Teva and Celltrion announce launch of Truxima® in the US, at a 10% price reduction compared to Rituxan®.

 

06 Nov 2019 | All | Henlius Biotech | Henlius Biotech wins 'Biosimilar Initiative of the Year' for its biosimilar rituximab at the Global Generics and Biosimilars Awards.

 

16 Oct 2019 | All | Samsung/Archigen Biotech | 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.

 

14 Oct 2019 | All | Roche | 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. 

 

08 Oct 2019 | All | Roche | 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. 

 

03 Oct 2019 | AU | 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.

 

19 Sep 2019 | All | Dr Reddy's | Dr Reddy's commences enrolment for Phase III trials of biosimilar rituximab

 

17 Sep 2019 | All | iBio | 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.

 

09 Sep 2019 | 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. 

 

24 Aug 2019 | All | Amgen/Allergan | Amgen presents results of clinical study comparing safety and efficacy of rituximab biosimilar candidate to originator, reporting clinical equivalence.

 

14 Aug 2019 | AU | Celltrion | 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®.

 

23 Jul 2019 | US | Pfizer | 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.

 

07 Jul 2019 | All | Genentech/Biogen | A new study reveals rituximab may be effective in managing mixed cryoglobulinemic vasculitis.

 

18 Jul 2019 | CN | Celltrion/Nan Fung/ Vcell | 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.

 

10 Jul 2019 | All | mAbxience | Study finds mAbxienxe's biosimilar rituximab candidate RTXM83 is not inferior to the reference drug in terms of efficacy. 

 

13 Jun 2019 | US | Roche | 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

 

29 May 2019 | JA | Genentech, Sandoz/Kyowa Kakko Kirin | Tokyo District Court judge dismisses Genentech's infringement suit against Sandoz and its local marketing partner Kyowa Hakko Kirin.

 

23 May 2019 | All | Innovent/Eli Lilly | Innovent and Eli Lilly announce rituximab biosimilar IBI301 met primary endpoints in Phase III clinical trials and PK study. 

 

11 Apr 2019 | AU | Sandoz/Roche | 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.

 

10 Apr 2019 | CA | Teva | Health Canada approves Teva's Truxima® for the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis in adult patients.

 

Mar 19 | AU | Celltrion | 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)

 

15 Mar 2019 | EU | Roche | 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.

 

01 Mar 2019 | AU | Celltrion  | Celltrion gains Australian approval for biosimilar rituximab under two product names, Rituzena® and Tuxella®.

 

22 Feb 2019 | CN | Shanghai Henlius Biotech | China's National Medical Products Administration approves first rituximab biosimilar, Hanlikon®.

 

24 Jan 2019 |US | Amgen, Allergan | Amgen announces results of Phase 1/Phase 3 Study of rituximab biosimilar candidate, confirming the study demonstrated favourable efficacy and safety profiles.

 

18 Jan 2019 | All | Celltrion, Samsung Biogen | Celltrion announces success in litigation against Samsung Biogen, invalidating Samsung Biogen's patent for biosimilar rituximab. 

 

27 Dec 2018 | All | JHL Biotech | 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.

 

14 Dec 2018 | US | Celltrion/Teva | 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.

 

28 Nov 2018 | US | Celltrion/Teva | 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.

 

01 Dec 2018 | EU | Sandoz | 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"

 

16 Nov 2018 | AU | Sandoz | 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.

 

02 Nov 2018 | US | Sandoz | Sandoz announces it will not pursue biosimilar rituximab in the US following requests from the FDA for additional information to complement the BLA.

 

19 Oct 2018 | US | Genentech | In advance of US biosimilar competitition, 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.0

 

10 Oct 2018 | US | Celltrion/Teva | US' Oncologic Drug Advisory Committee unanimously recommends Celltrion's CT-P10 for approval as a biosimilar to Rituxan.

 

07 Oct 2018 | US | Merck & Co/Samsung Bioepis| Merck secures 5 year, $117.5M deal with US Department of Veterans Affairs to supply rituximab biosimilar developed by Samsung.

 

03 Sep 2018 | EU | AryoGen Pharmed | 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. 

 

09 Jul 2018 | CN | iBio, CC-Pharming | iBio and CC-Pharming enter agreement to develop biosimilar rituxumab for the Chinese market.

 

30 May 2018 | US | Celltrion/Teva | 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.

 

02 May 2018 | US | Sandoz | Sandoz announces that the FDA has provided a CRL rejecting its BLA for biosimilar rituximab.

 

14 Apr 2018 | AU | Celltrion | 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.

 

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.

 

9 Mar 2018 | Turkey | TRPharm/Dr Reddy's | TRpharm announces it is ready to launch biosimilar rituximab (developed by Dr Reddy's) in Turkey, following approval on 30 Jan 2018. 

 

24 Jan 2018 | All | Pfizer | Pfizer announces positive top line results for PF-05280586, biosimilar to Rituxan/MabThera.

 

16 Jan 2018 | JP | Sandoz | 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. Read more 

 

11 Jan 2018 | US | Teva/Celltrion | 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.  Read more

 

21 Dec 2017 | AU | Roche/Sandoz | 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.

 

30 Nov 2017 | AU | Sandoz | Sandoz's biosimilar rituximab, Riximyo® approved in Australia, following its approval in Europe 5 months earlier.

 

26 Oct 2017 | RU | Biocad | Russian biosimilars company Biocad succeeds in Russian patent challenge relating to the use of Rituxumab for RA, and announces intention to launch in EU.  Read more

 

12 Sep 2017 | US | Sandoz | FDA accepts Sandoz’s s351(k) application for rituximab.  Read more

 

1 Aug 2017 | EU | Celltrion/Mundipharma | Celltrion/Mundipharma claim their biosimilar rituximab (Truxima®) has 30% of total EU market due to rapid growth. Read more 

 

Jun 2017 | US | Celltrion/Teva | FDA accepted Teva/Celltrion's aBLA for CT-P10, biosimilar rituximab. Read more 

 

19 June 2017 | EU | Sandoz | EU approval received for Sandoz's Rixathon® (biosimilar rituximab) to treat blood cancers and immunological diseases.  Read more

 

22 Feb 2017 | EU | Mundipharma/Celltrion| 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. Read more

 

09 Oct 2016 | US & CA | Teva/Celltrion | Teva and Celltrion announce exclusive marketing deal under which Teva will commercialise Celltrion's biosimilar rituximab and trastuzumab products in the US and CA.  Read more

 

30 Aug 2011 | EU | Stada/Richter | Stada and Gedeon Richter announce collaboration deals to develop and sell biosimilars rituximab and trastuzumab. Read more 

 

 

 

Share on Facebook
Share on Twitter
Please reload

Biosimilars Bulletin 

November 9, 2020

Please reload

Search by tags