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Celltrion receives approval for biosimilar infliximab from Health Canada
Celltrion announces it has received a notice of compliance from Health Canada for Remsima® SC (subcutaneous infliximab). Remsima® has been approved for the treatment of rheumatoid arthritis.
Vizient releases Pharmacy Market Outlook
New study shows long-term biosimilarity of Truxima® to Rituxan®
A new long-term efficacy and safety study demonstrated the biosimilarity of Celltrion’s CT-P10/Truxima® (infliximab) to Rituxan® at 27 months in patients with low-tumor burden follicular lymphoma.
Celltrion’s Remsima® in auto-injection pen approved by TGA
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.
Results from post-marketing studies of Renflexis® released by 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.
Celltrion presents interim results at the UEG Week Virtual 2020
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.
Intract Pharma and Celltrion sign development agreement
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.
Celltrion refutes claims of study on Remsima® and Remicade®
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.
Celltrion’s Q2 FY20 earnings report is released
Celltrion releases its Q2 FY20 earnings report. Celltrion reported that Remsima SC® remains in Ph III clinical trials in the US.
European Commission grants marketing authorisation for Remsima®
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.
Centre of Biosimilars reports the potential of Remsima® as COVID-19 treatment
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.
Celltrion announces EU’s CHMP recommendations for additional indications of subcut Remsima®
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.
Celltrion’s infliximab biosimilar CT-P13 announced as trial of CATALYST Study
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.
Health New England announces savings through utilisation of biosimilar infliximab
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.
Mabpharm submits a New Drug Application
Sorrento Therapeutics announces partner Mabpharm has submitted a New Drug Application for its biosimilar infliximab to the Chinese NMPA.
Avsola® approved by FDA
FDA approves Avsola® for all indications.
Biogen and Samsung Bioepis partnership for commercialisation announced
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.
Data from Inflectra® analysis released
Pfizer releases positive interim analysis of data from clinical trials of Pfizer’s Inflectra®.
Results of Phase I clinical trials of infliximab biosimilar released
Amgen releases results of Phase I clinical trials of infliximab biosimilar, reporting PK similarity as well as similar safety and immunogenicity profiles.
CMHP approves of additional indication for Remsima®
CMHP adopts positive opinion for additional indication for Remsima®, to include the treatment of rheumatoid arthritis.
Celltrion’s partnership with Lonza announced
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.
Patient enrolment for Phase III clinical trials announced by Celltrion
Celltrion announces commencement of patient enrolment for Phase III clinical trials of subcutaneous biosimilar infliximab,CT-P13.
Creation of JV Co with Nan Fund Group for commercialisation announced by Celltrion
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.
Amgen’s Marketing Authorisation application withdrawn
Amgen withdraws its Marketing Authorisation application for biosimilar infliximab ABP710, citing a change in product strategy.
Product specific reports based on extracts from our BioBlast® database
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