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Rituxan®/MabThera® | Rituximab | Genentech/Biogen

November 8, 2019

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 be 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 




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