Remicade® | Infliximab | Johnson & Johnson

November 12, 2020

12 Nov 20 | AU | Celltrion | The TGA approves Celltrion's subcutaneous "biobetter" infliximab product Remsima in auto-injection pen and PFS presentations. This is the first subcut infliximab product to be approved in Australia.

 

26 Oct 20 | All | Samsung Bioepis | Samsung Bioepis announces results from two post-marketing studies of Renflexis® (biosimilar infliximab) in Veteran Affairs patients with IBD. The first study evaluated the safety of switching from reference infliximab to Renflexis®, finding that patients who were on reference product or biosimilar infliximab can remain stable after switching to another biosimilar without major safety concerns. The second study looked at utilisation patterns of infliximab for IBD, finding that the uptake of Samsung Bioepis' Renflexis® (following its listing as the preferred product on the Veterans Affairs National Formulary Policy) was faster than the adoption of the previous biosimilar listed in the year prior.

 

10 Oct 20 | All | Celltrion | Celltrion presents positive interim results from Ph I trials of CT-P13 of subcutaneous Remsima® (biosimilar infliximab) in IBD at the UEG Week Virtual 2020. The results indicated that subcutaneous infliximab may be associated with better clinical outcomes compared to intravenous infliximab.

 

20 Aug 20 | All | Intract Pharma, Celltrion | Intract Pharma and Celltrion announce an agreement to jointly develop the world's first oral antibody therapeutic for the treatment of IBD. The infliximab product has been cleared by the UK's MHRA to proceed to Ph 1b/2a clinical trials in patients with IBD during the second half of 2021.

 

14 Aug 20 | US | Celltrion | The Centre for Biosimilars reports that Celltrion has refuted the claims of a July 2020 study which critiqued the methods used by Celltrion and the FDA to determine whether Remsima® (biosimilar infliximab) was equivalent to Remicade®. Among its critiques of the study, Celltrion has argued that the study does not reflect the FDA review procedure and the principles of the regulatory guidelines.

 

07 Aug 20 | US | Celltrion | Celltrion releases its Q2 FY20 earnings report. Celltrion reported that Remsima SC® remains in Ph III clinical trials in the US.

 

27 Jul 20 | EU | Celltrion | Celltrion announces the European Commission has granted marketing authorisation for Remsima® (biosimilar infliximab) subcutaneous formulation for the treatment of adult patients with ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis and psoriasis.

 

14 Jul 20 | All | Celltrion | In an interview with the Centre for Biosimilars, Celltrion's head of marketing, Byoungseo Choi reports Remsima® (biosimilar infliximab) is showing promise as a potential treatment for COVID-19. 

 

28 June 20 | EU | Celltrion | Celltrion announces EU's CHMP recommended expanding the marketing authorisation for its subcut Remsima® (biosimilar infliximab) to include the following additional indications: IBD, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis and psoriasis. This extends the indications beyond RA which was approved in November 2019.

 

10 June 2020 | All | Celltrion | The University of Oxford announces Celltrion's infliximab biosimilar CT-P13 (Inflectra, Remsima) would be one of the products trialled in the CATALYST Study. This study is examining possible treatments for patients with COVID-19. It is hoped that the CT-P13 will prevent the immune system response which leads to cytokine storm syndrome in COVID patients.

 

22 Jan 2020 | US | All | Health New England, a nonprofit health plan in Massachusetts, announces savings of $1.7 million in the past year by reaching 93% utilisation of biosimilar infliximab.

 

06 Jan 2020 | CN | Mabpharm, Sorrento | Sorrento Therapeutics announces partner Mabpharm has submitted a New Drug Application for its biosimilar infliximab to the Chinese NMPA.

 

06 Nov 2019 | US | Amgen | FDA approves Avsola® for all indications. 

 

06 Nov 2019 | CN | Biogen, Samsung Bioepis | Biogen and Samsung Bioepis announce partnership for the commercialisation of biosimilar ranibizumab and aflibercept for major markets world side including the US, Canada, Europe, Japan and Australia. Biogen has also acquired exclusive commercialisation rights for its anti-TNF portfolio, including BENEPALI® (etanercept), FLIXABI® (infliximab) and IMRALDI® (adalimumab), in China.  Under the agreement, Biogen will make one $100 million upfront payment, with up to $210 million payable at additional development, regulatory and sales-based milestones.

 

01 Nov 2019 | All | Pfizer | Pfizer releases positive interim analysis of data from clinical trials of Pfizer's Inflectra®. 

 

19 Oct 2019 | All | Amgen | Amgen releases results of Phase I clinical trials of infliximab biosimilar, reporting PK similarity as well as similar safety and immunogenicity profiles.

 

22 Sep 2019 | EU | Celltrion | CMHP adopts positive opinion for additional indication for Remsima®, to include the treatment of rheumatoid arthritis.

 

03 Sep 2019 | All | Celltrion | Celltrion announces patnership with Lonza for the production of Remsima®. Lonza will now work within Celltrion's network to complement Celltrion's own production capacity.

 

31 Jul 2019 | All | Celltrion | Celltrion announces commencement of patient enrolment for Phase III clinical trials of subcutaneous biosimilar infliximab,CT-P13.

 

18 Jul 2019 | CN | Celltrion/Nan Fung/ Vcell | Celltrion announces creation of JV Co 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.

 

01 Jul 2019 | EU | Amgen | Amgen withdraws its Marketing Authorisation application for biosimilar infliximab ABP710, citing a change in product strategy.

 

19 Apr 2019 | All | Sandoz | Sandoz reports results of long term studies  (up to 54 weeks) on the efficacy, safety and immunogenicity of infliximab biosimilar.  This product was initially developed by Pfizer and acquired by Sandoz.

 

14 Mar 2019 | UK | Merck Sharp & Dohme  | UK Competition and Markets Authority closes investigation into Merck discount scheme after finding no grounds for further action. This decision is contrary to the provisional findings in May 2017 which indicated a breach of competition law.

 

08 Mar 2019 | All | Celltrion | Celltrion claims results of 1 year comparison study of subcutaneous formulation of infliximab biosimilar demonstrate comparable efficacy and safety with intravenous formulation.

 

4 Jan 2019 | All | Celltrion | Celltrion announces it will establish a direct sales network minimising sales partners, including for its biosimilar infliximab, Remsima®.

 

17 Dec 2018 | US | Amgen | Amgen files BLA for biosimilar infliximab. 

 

16 Dec 2018 | EU | Celltrion | French study supports the use of Remsima® in the treatment of Crohn's disease, showing equivalency to reference product in safety and effectiveness.

 

04 Dec 2018 | EU | Celltrion | The EMA accepts Celltrion's application for a subcut formulaton of bosimilar infliximab, Remsima SC.  

 

27 Aug 2018 | US | Pfizer | Pfizer accuses originators of using scare campaigns to undermine confidence in biosimilars in a citizen's petition seeking guidance on the representations which can be made about biosimilar products.  Pfizer criticises the slower uptake of biosimilars in the US in comparison to Europe, alleging that false and misleading statements made by originators have contributed to this. 

 

27 Jun 2018 | All | Amgen | Amgen releases results of Phase III study of infliximab biosimilar, revealing no clinically meaningful differences to Remicade®.

 

25 Jun 2018 | LY/TN | Celltrion | Celltrion launches infliximab biosimilar in Libya and Tunisia. The product will be distributed through Celltrion's local partner Hikma Pharmaceuticals and is part of Celltrion's overall plan to expand sales networks across Africa and into the Middle East.

 

15 Jun 2018 | All | Sandoz | Sandoz reports results of long term switching studies for biosimilars Zessly®(infliximab) and Erelzi® (etanercept) in RA.

 

14 Jun 2018 | All | Biocad | Biocad announces phase III clinical trials of ASART-2, biosimilar infliximab, reveal non-inferiority to Remicade at week 54.

 

12 Jun 2018 | All | Celltrion | Celltrion reports preliminary results for new sub-cut formulation of infliximab. 

 

6 Jun 2018 |US | Walgreen/Kroger | Walgreen and Kroger also file suit against J&J in the Pennsylvania District Court, echoing Pfizer's earlier (Nov 17) complaint alleging J&J has engaged in anti-competitive behaviour regarding the US sale of Remicade®.

 

15 May 2018 | US |Pfizer | FDA approves epoetin alfa biosimilar for the treatment of anaemia caused by chronic kidney disease, chemotherapy or use of zidovudine.

 

24 Mar 2018 | EU | Sandoz | Sandoz announces it has received EU approval for Zessly (inflliximab) for all originator indications.

 

23 Mar 2018 | EU | Sandoz | Sandoz announces that it has received a positive CHMP opinion for biosimilar infliximab Zessly®.

 

Jan 2018 | RU | Biocad | Biocad obtains approval for its biosimilar infliximab in Russia. 

 

23 Jan 2018 | Celltrion/Pfizer | US Court of Appeals (Fed Cir) affirms patent invalidity.

 

13 Dec 2017 | US | Pfizer | FDA approves biosimilar infliximab, Ixifi® for the treatment of patients with rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriosis. 

 

10 Nov 2017 | US | Samsung Bioepis | Janssen withdraws suit against Samsung Bioepis filed in the District Court of New Jersey for patent infringement under the BPCIA in May 2017 (see below).

 

29 Oct 2017 | All | Celltrion | Celltrion releases phase III results for switching studies comparing Biosimilar infliximab CT-P13 (marketed by Celltrion as Remsima® and by Pfizer as Inflectra®) and Remicade®, and phase I (open label) studies for sub-cutaneous infliximab.  Read more

 

6 Sep 2017 | US | Celltrion/Pfizer | FDA releases Form 483 raising 12 issues arising from the May/June inspections of the Celltrion Incheon biologics manufacturing facility, where Celltrion and Pfizer/Hospira's biosimilar Inflectra® (infliximab-dyyb) is made.  Read more

 

1 Aug 2017 | AU | Merck/Samsung Bioepis | Merck’s biosimilar infliximab (Renflexis®), co-developed with Samsung Bioepis, is the second biosimilar to be PBS listed in Australia. Read more here and here.

 

24 Jul 2017 | US | Samsung Bioepis | Samsung Biopeis launches Renflexis® , biosimilar to J&J’s Remicade® in the US following its April approval in the US.  Read more

 

17 May 2017 | US | Samsung Bioepis | Janssen commences BPCIA proceedings against Samsung Bioepis in the District Court of New Jersey based on Samsung's aBLA application for Renflexis® infliximab-abda, biosimilar to J&J’s Remicade®.  Read more

 

24 Apr 2017 | US | Samsung Bioepis | FDA approves Samsung Biopeis’ Renflexis® infliximab-abda, biosimilar to J&J’s Remicade® for all eligible indications.  Read more

 

Nov 2016 | US | Celltrion/Pfizer | Commercial (at risk) launch by Pfizer/Celltrion of Inflectra® (infliximab-dyyb).

 

30 May 2016 | EU | Biogen/Samsung Biopeis | Biogen/Samsung Biopeis receive EMEA approval for Flixabi, biosimilar Infliximab.  Read more

 

5 Apr 2016 | US | Celltrion/Pfizer | Pfizer/Celltrion received FDA approval for Inflectra®, biosimilar infliximab Read more 

 

1 Apr 2016 | EU | Samsung Bioepis | EU’s CHMP gives green light for Flixabi®, Samsung Bioepis’ biosimilar infliximab.  Read more

 

11 Jan 2016 | All | Sorrento/MabTech | MabTech announces successful Chinese Ph III clinical trials for Sorrento's "biosimilar/biobetter" cetuximab STI-001, and infliximab STI-002. 

 

1 Dec 2015 | AU | Pfizer (Hospira) | Hospira's biosimilar infliximab becomes the first biosimilar infliximab to be PBS listed in Australia.  Read more

 

15 Jan 2014 | CA | Celltrion/Hospira | CA approval for Celltrion/Hospira's infliximab Biosimilar products to be marketed as Remsima® and Inflectra®. Read more here and here

 

10 Sep 2013 | EU | Celltrion/Hospira | Hospira/Celltrion's infliximab biosimilar products approved in EU (Remsima® and Inflectra®)Read more 

 

 

 

 

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Biosimilars Bulletin 

November 9, 2020

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