BioBlast®

Korea Biomedical Review reported that Boditech Med has obtained approval in Korea for its AFIAS infliximab system. AFIAS infliximab is a therapeutic drug monitoring device used to measure infliximab levels in the blood and check for adverse reactions.

The Korea Herald reported that Samsung Bioepis has secured a total of 10 biosimilar products on its 10^th year anniversary.  Six biosimilars have been approved globally: infliximab, etanercept, adalimumab, trastuzumab, bevacizumab and ranibizumab.  Eculizumab has recently completed its Ph III clinical trial, and three other biosimilar candidates are under Ph III trials.

Celltrion released two data sets on the subcutaneous (SC) form of Remsima® (biosimilar infliximab).  Celltrion reported that switching from IV to SC infliximab leads to higher infliximab trough levels and a lower risk of relapse in patients with IBD.

The Korea Herald reported that Celltrion’s Remsima® (biosimilar infliximab) has captured 33.7% of the US market for infliximab since its approval in April 2016.

Vizient announced that remdesivir has replaced Humira® (adalimumab) as the most expensive drug by total member spend in its Winter 2022 Market Outlook.  Pembrolizumab, ustekinumab, ocrelizumab, denosumab, infliximab, nivolumab and tocilizumab also featured in the top 10 most expensive drugs by member spend.

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.

Celltrion presented two new data sets on the use of Remsima® SC (biosimilar infliximab) in inflammatory bowel disease in a poster presentation at United European Gastroenterology Week 2021.

Pfizer and Johnson & Johnson (J&J) settled the antitrust litigation relating to Pfizer’s Inflectra® (infliximab biosimilar). Pfizer had alleged that J&J’s payer contracts restricted the use of Inflectra® by denying reimbursement unless Remicade was first proven ineffective for patients, causing a reluctance among pharmacies to stock Inflectra®. Details of the settlement have not been published.

Sorrento announced that China’s NMPA has granted marketing approval for Mabpharm’s infliximab ‘biobetter’. Sorrento holds exclusive commercial rights to the product outside of China and disclosed that it plans to file a BLA in the EU and US in 2021.

The UK’s NICE finalised its guidance on the treatment of moderate rheumatoid arthritis, recommending the use of adalimumab, etanercept, infliximab and abatacept for patients with moderate rheumatoid arthritis which is inadequately controlled on conventional therapies.

Nichi-Iko announced it has entered a licence and supply agreement with Laboratorio Elea Phoenix for a biosimilar infliximab product. Under the agreement Nichi-Iko will supply the product to Elea for the Argentine market.

The UK’s NICE published final draft guidance recommending adalimumab, etanercept and infliximab for the treatment of moderate rheumatoid arthritis on the NHS. Previously, biologics had been recommended only for severe rheumatoid arthritis.

Celltrion launched Remsima SC® (subcutaneous infliximab biosimilar) in Canada.  Remsima SC® is indicated for the treatment of rheumatoid arthritis.

Sarcoidosis News reported a new study demonstrates that patients with sarcoidosis can safely switch from Remicade® (infliximab) or Inflectra® (biosimilar infliximab) to Flixabi® (biosimilar infliximab) and maintain similar clinical benefits.  Infliximab is not indicated for sarcoidosis, but is commonly used off-label and has been shown to improve lung function in refractory patients.

Merck reported the vision, focus and business model for its new standalone company, Organon.  Merck disclosed that Organon with have a direct sales presence in 58 markets, with key growth drivers in Organon’s biosimilars portfolio expected to be Renflexis® (biosimilar infliximab), Aybintio® (biosimilar bevacizumab) and Hadlima® (biosimilar adalimumab).

Samsung Bioepis released its Q1 2021 financial results.  Global sales for Benepali® (biosimilar etanercept), Flixabi® (biosimilar infliximab) and Imraldi® (biosimilar adalimumab) increased 3.9% quarter-on-quarter, with Benepali® accounting for the largest share of those sales.

Celltrion received a positive CHMP opinion for Remsima® subcut (subcutaneous infliximab). Remsima® SC was recommended for the direct use without IV loading in patients with rheumatoid arthritis.

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.

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.

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.

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.

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 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 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.

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

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.

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 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.

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, a nonprofit health plan in Massachusetts, announces savings of $1.7 million in the past year by reaching 93% utilisation of biosimilar infliximab.

Sorrento Therapeutics announces partner Mabpharm has submitted a New Drug Application for its biosimilar infliximab to the Chinese NMPA.

FDA approves Avsola® for all indications.

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.

Pfizer releases positive interim analysis of data from clinical trials of Pfizer’s Inflectra®.

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

CMHP adopts positive opinion for additional indication for Remsima®, to include the treatment of rheumatoid arthritis.

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.

Celltrion announces commencement of patient enrolment for Phase III clinical trials of subcutaneous biosimilar infliximab,CT-P13.

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 withdraws its Marketing Authorisation application for biosimilar infliximab ABP710, citing a change in product strategy.

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.

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.

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

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

Amgen files BLA for biosimilar infliximab.

French study supports the use of Remsima® in the treatment of Crohn’s disease, showing equivalency to reference product in safety and effectiveness.

The EMA accepts Celltrion’s application for a subcut formulation of biosimilar infliximab, Remsima SC®.

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.

Amgen releases results of Phase III study of infliximab biosimilar, revealing no clinically meaningful differences to Remicade®.

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.

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

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

Celltrion reports preliminary results for new sub-cut formulation of infliximab.

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®.

Sandoz announces it has received EU approval for Zessly® (inflliximab) for all originator indications.

FDA approves epoetin alfa biosimilar for the treatment of anaemia caused by chronic kidney disease, chemotherapy or use of zidovudine.

Sandoz announces that it has received a positive CHMP opinion for biosimilar infliximab Zessly®.

US Court of Appeals (Fed Cir) affirms patent invalidity.

Biocad obtains approval for its biosimilar infliximab in Russia.

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.

Janssen withdraws suit against Samsung Bioepis filed in the District Court of New Jersey for patent infringement under the BPCIA in May 2017.

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.

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.

Merck’s biosimilar infliximab (Renflexis®), co-developed with Samsung Bioepis, is the second biosimilar to be PBS listed in Australia.

Samsung Biopeis launches Renflexis® , biosimilar to J&J’s Remicade® in the US following its April approval in the US.

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®.

FDA approves Samsung Biopeis’ Renflexis® infliximab-abda, biosimilar to J&J’s Remicade® for all eligible indications.

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

Biogen/Samsung Biopeis receive EMA approval for Flixabi®, biosimilar Infliximab.

Pfizer/Celltrion received FDA approval for Inflectra®, biosimilar infliximab.

EU’s CHMP gives green light for Flixabi®, Samsung Bioepis’ biosimilar infliximab.

MabTech announces successful Chinese Ph III clinical trials for Sorrento’s “biosimilar/biobetter” cetuximab STI-001, and infliximab STI-002.

Hospira’s biosimilar infliximab becomes the first biosimilar infliximab to be PBS listed in Australia.

CA approval for Celltrion/Hospira’s infliximab biosimilar products to be marketed as Remsima® and Inflectra®.

Hospira/Celltrion’s infliximab biosimilar products approved in EU (Remsima® and Inflectra®).