Biogen’s Imraldi, an adalimumab biosimilar candidate referencing Humira, granted positive opinion by CHMP
![](/46/pdcnewsitem/04/69/65/biogen.jpg)
If approved, Imraldi will be the third anti-TNF biosimilar in Biogen’s portfolio in Europe.
The Committee for Medicinal Products for Human Use (CHMP) of the EMA has issued a positive opinion for Imraldi (also known as SB5), an adalimumab biosimilar candidate referencing Humira. The positive opinion will now be referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union (EU). Imraldi marks the third anti-TNF candidate to be submitted to the EMA by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen.
If approved by the EC, Imraldi will be approved for the treatment of rheumatoid arthritis, axial spondyloarthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis, polyarticular juvenile idiopathic arthritis, active enthesitis-related arthritis, hidradenitis suppurativa and non-infectious uveitis.
Today, the anti-TNF market alone accounts for an estimated $9 billion of healthcare expenditures in Europe, of which Humira accounts for $4 billion. Global sales estimates for Humira stand at $16 billion in 2017, making it the number-one prescribed biologic therapy in the world. Earlier this year, data were unveiled at the ISPOR 22nd Annual Meeting in Boston showing that biosimilar introduction of the top-three anti-TNF therapies in Europe could result in savings of $11.44 billion by 2020. Of these savings, $3.18 billion could be attributed to prescribing an adalimumab biosimilar referencing Humira, despite only being approved near the end of the study period.
“If Imraldi receives approval, Biogen will be the first company to have approved biosimilars of the three most prescribed anti-TNF biologic treatments in Europe,” said Alpna Seth, Senior Vice President and Global Head of the Biosimilars Business Unit at Biogen. “This portfolio expansion is in line with our mission to increase access to biologics that have transformed the treatment of chronic autoimmune conditions like rheumatoid arthritis. Being able to provide this range of anti-TNF treatment alternatives bolsters our leadership position and underscores our commitment to expanding physician choice, while supporting the sustainability of healthcare systems.”
The positive opinion is based on a robust preclinical and clinical data package comparing Imraldi with Humira. The clinical data include results from two head-to-head studies – a Phase I study in healthy volunteers that demonstrated pharmacokinetic bioequivalence to Humira and a Phase III, randomized, double-blind, multicenter study, in which Imraldi demonstrated equivalent efficacy and comparable safety and immunogenicity to Humira in patients with RA. The primary endpoint of the Phase III study, the American College of Rheumatology 20% (ACR20) response at Week 24, was met, demonstrating equivalent efficacy to Humira. Secondary endpoints demonstrated that Imraldi has a comparable safety and immunogenicity profile to Humira.
Related News
-
News Eli Lilly’s Alzheimer’s drug receives approval from US FDA
After facing several hurdles on its path to approval last year, Eli Lilly’s donanemab treatment for early Alzheimer’s, brand name Kisunla, received US FDA approval this past week. It is the second therapy for slowing the progression of Alzh... -
News This week in GLP-1 drug headlines: Manufacturing investment and new market launches
As drugmakers race to put their own GLP-1 drug products forward as the next biggest thing in weight-loss, current products are making numerous headlines this week with a number of new developments in their commercialisation and approval. Discover the l... -
News Women in Pharma: Regulating equity across regional borders
In our monthly series focusing on women in the pharmaceutical industry, we interview leading experts in the pharmaceutical supply and value chain to discuss the importance of gender diversity in healthcare, the workplace, and beyond. -
News Viral marketing for B2B pharma businesses: a CPHI Online case study
Discover how a Chinese chemical manufacturing company went viral on TikTok, and what their viral success means for the future of B2B digital marketing for the wider pharmaceutical industry and supply chain. -
News New Aurigene biologics facility opens in Hyderabad, India
Aurigene Pharmaceutical Services Ltd. have opened a biologics facility in Hyderabad, India in a biocluster known as Genome Valley. -
News Novo Nordisk launches 'Power of Wegovy' national campaign
Danish drugmaker Novo Nordisk have launched a new national campaign – The Power of Wegovy – that aims to educate those living with obesity on their blockbuster drug Wegovy throughout the United States. -
News Women in Pharma Anniversary: Celebrating Our Heroines of Pharma
Our Women in Pharma interview series is approaching its 1-year anniversary this month, and to celebrate, we are highlighting the Heroines of Pharma that our very own Women in Pharma admire. -
News Sanofi gains rare disease therapy in acquisition of Inhibrx for US$1.7 billion
Sanofi completed the acquisition of the clinical-stage biotech company Inhibrx in late May 2024 after settling on a US$1.7 billion buyout. The acquisition brings with it a rare disease therapy to bollster Sanofi's pipeline.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance