Ustekinumab

EQS-News: Formycon and Fresenius Kabi reach settlement agreement for ustekinumab biosimilar candidate FYB202 in Europe and Canada

Retrieved on: 
Wednesday, April 10, 2024
Ulcerative colitis, Psoriasis, Ustekinumab, Patient, EMA, Interleukin, European Medicines Agency, Fresenius (company), Cytokine, Johnson & Johnson, FDA, Food, Pharmaceutical industry

Press release // March 18, 2024

Key Points: 
  • Press release // March 18, 2024
    Munich, Germany – Formycon AG (FSE: FYB) and its commercialization partner Fresenius Kabi today announced the signing of a settlement agreement with Johnson & Johnson concerning the commercialization of FYB202, a biosimilar to Stelara®1 (ustekinumab), in Europe and Canada.
  • It was agreed to keep the terms of the agreement confidential.
  • Our aim is to make a significant difference in patients' lives by providing them with reliable, high-quality, and affordable treatment options.
  • In February 2023, Formycon and Fresenius Kabi had entered into a global license agreement for the ustekinumab biosimilar candidate FYB202, under which FYB202 will be marketed by Fresenius Kabi in key global markets following successful approval.

Samsung Bioepis Presents Two Abstracts for Its Immunology Portfolio at the 2024 American Academy of Dermatology (AAD) Annual Meeting

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Saturday, March 9, 2024
EMA, Week, Psoriasis, Committee, SB5, Political moderate, Ustekinumab, Organon, FDA, Food, Samsung, BLA, Trial of the century, AAD, Safety, CHMP, Pharmacokinetics, Abstract, Biologics license application, American Academy, Novartis, Interchangeability

“We are excited to present new clinical data for our immunology portfolio at AAD Annual Meeting.

Key Points: 
  • “We are excited to present new clinical data for our immunology portfolio at AAD Annual Meeting.
  • The high-concentration (40 mg/0.4 mL) formulation of prefilled syringe and prefilled autoinjector of HADLIMA was approved in August 2022.
  • The study showed that efficacy, safety, and immunogenicity between the three arms were comparable up to Week 52.
  • Details of the Samsung Bioepis’ abstracts are as follows:
    Clinical Similarity of SB17 (Proposed Ustekinumab Biosimilar) to Reference Ustekinumab in Patients with Moderate to Severe Plaque Psoriasis: Randomized, Double-blind, Phase III, 52-Week Results

Biocon Biologics Secures US Market Entry Date for Bmab 1200, a Proposed Biosimilar to Stelara®

Retrieved on: 
Thursday, February 29, 2024
Psoriatic arthritis, Ulcerative colitis, Crohn's disease, Psoriasis, Ustekinumab, Trademark, FDA, Patent, Johnson & Johnson, BLA, Inflammation, IPR, PTAB, Inter partes review, Patient, Science, BBL, Pharmaceutical industry

The agreement licenses the Company to launch in the United States, in February 2025, once approved by the U.S. FDA.

Key Points: 
  • The agreement licenses the Company to launch in the United States, in February 2025, once approved by the U.S. FDA.
  • The U.S. FDA has accepted the Company's Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway.
  • Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd, said: "This settlement agreement reflects our commitment and focus on science and innovation.
  • As a fully integrated biosimilars company, Biocon Biologics is committed to expanding access to life-changing treatments with our broad portfolio of products."

AbbVie Unveils New Data from Robust Gastroenterology Portfolio at the 19th Congress of European Crohn's and Colitis Organisation (ECCO)

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Monday, February 19, 2024
ABBV, Ulcerative colitis, Collection, Crohn's disease, Research, Inflammatory Bowel Diseases, University of Calgary, Risankizumab, AbbVie, INSPIRE, Safety, University, UC, Boehringer Ingelheim, Burrill Bernard Crohn, Abstract, Inflammatory bowel disease, Patient, Ustekinumab, Pharming, Medicine, IBD, Disease, Congress, ECCO, Pharmaceutical industry

NORTH CHICAGO, Ill., Feb. 19, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced that 17 AbbVie-sponsored abstracts, including new data from its inflammatory bowel disease (IBD) portfolio, have been accepted for presentation at the 19th Congress of European Crohn's and Colitis Organisation (ECCO) taking place in Stockholm, Sweden from February 21-24.

Key Points: 
  • The research spans risankizumab (SKYRIZI®) and upadacitinib (RINVOQ®) in both Crohn's disease (CD) and ulcerative colitis (UC).
  • "Despite continued advancements, many patients are still suffering from the debilitating effects of living with IBD," said Sofie Berg, Pharm.D, Ph.D., therapeutic area head, international immunology, International Medical Affairs, AbbVie.
  • "It is critically important that as the treatment paradigm shifts, the gastroenterology community shifts with it.
  • SKYRIZI® (risankizumab) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

Rani Therapeutics Announces Positive Topline Results from Phase 1 Study of an Oral Anti-Interleukin 12/23 Antibody (RT-111)

Retrieved on: 
Monday, February 5, 2024
Pharmacokinetics, Peptide, Cytokine, Human, Trial of the century, Patient, Safety, Psoriasis, Interleukin, Ustekinumab, Biosimilar, Volunteering, Ulcerative colitis, Vaccine

ET / 5:30 a.m. PT –

Key Points: 
  • ET / 5:30 a.m. PT –
    SAN JOSE, Calif., Feb. 05, 2024 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced positive topline results from its Phase 1 clinical study of RT-111, a RaniPill® capsule containing an ustekinumab biosimilar, CT-P43.
  • In the study, RT-111 was well-tolerated and delivered ustekinumab with high bioavailability.
  • “We are highly encouraged by the positive results from our Phase 1 study for RT-111 – our third successfully completed Phase 1 trial using RaniPill® technology.
  • To our knowledge, RT-111 is the first ever oral monoclonal antibody to achieve high bioavailability in humans,” said Talat Imran, Chief Executive Officer of Rani.

Johnson & Johnson Reports Q4 and Full-Year 2023 Results

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Tuesday, January 23, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Growth, Contact, Ustekinumab, Esketamine, General surgery, Infliximab, Abiraterone acetate, Press release, Acquisition, COVID-19, Medtech, Johnson & Johnson, Abiomed, Daratumumab, Security (finance), News, Pharmaceutical industry

Adjusted operational sales* reflected below excludes the net impact of acquisitions and divestitures and translational currency.

Key Points: 
  • Adjusted operational sales* reflected below excludes the net impact of acquisitions and divestitures and translational currency.
  • Innovative Medicine worldwide operational sales, excluding the COVID-19 Vaccine, grew 7.2%*.
  • Notable New Announcements in the Quarter:
    The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K.
  • Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson.

STADA and Alvotech secure approval for Uzpruvo, Europe’s first ustekinumab biosimilar to Stelara

Retrieved on: 
Wednesday, January 10, 2024
Psoriatic arthritis, Dermatology, Patient, CHMP, BAD, Cytokine, Partnership, Ustekinumab, Rheumatology, Civil service commission, Biosimilar, European Commission, Adalimumab, Partner, EMA, Psoriasis, Safety, SPC, Committee, Marketing, Gastroenterology, Pharmaceutical industry

Biosimilar competition in the €2.5 billion (US$2.7 billion) EU ustekinumab market could significantly expand patient access to this life-changing biologic therapy within gastroenterology, dermatology, and rheumatology.

Key Points: 
  • Biosimilar competition in the €2.5 billion (US$2.7 billion) EU ustekinumab market could significantly expand patient access to this life-changing biologic therapy within gastroenterology, dermatology, and rheumatology.
  • STADA’s Global Specialty Head, Bryan Kim, commented: “This first marketing authorization for biosimilar ustekinumab in Europe offers the potential to expand substantially patient access through competition.
  • Under a strategic partnership begun in 2019, Alvotech is primarily responsible for developing and manufacturing the AVT04 ustekinumab biosimilar.
  • These include a high-concentration, citrate-free adalimumab biosimilar developed and marketed through the partnership between Alvotech and STADA.

FDA Accepts for Review BLA for DMB-3115 of Dong-A ST, a Proposed Biosimilar to Stelara® (Ustekinumab)

Retrieved on: 
Friday, January 5, 2024
Health, FDA, Other Health, Research, Science, Pharmaceutical, Biotechnology, Food, Ustekinumab, EMA, MAA, Intas Pharmaceuticals, Inflammation, USD, IQVIA, Ulcerative colitis, CSO, Patient, Safety, Psoriasis, Psoriatic arthritis, BLA, Pharmaceutical industry

The BLA leverages the analytical similarity assessment data between EU and US sourced Stelara® and DMB-3115.

Key Points: 
  • The BLA leverages the analytical similarity assessment data between EU and US sourced Stelara® and DMB-3115.
  • It recorded USD 17.77 billion in sales (IQVIA Accumulative Sales) in 2022 and is one of the world’s best-selling biologics.
  • The rights of Dong-A Socio Holdings for R&D and commercialization were transferred to Dong-A ST in July 2020 for efficient project management.
  • Intas Pharmaceuticals plans to commercialize DMB-3115 through Accord BioPharma (US), Accord Healthcare (EU, UK, and Canada), and other subsidiaries around the world.

Accord BioPharma, Inc. Announces U.S. FDA Acceptance of Biologics License Application for Proposed STELARA® Biosimilar DMB-3115

Retrieved on: 
Thursday, January 4, 2024
Biology, Partnership, Food, Pegfilgrastim, Johnson & Johnson, Trastuzumab, Crohn's disease, FDA, Filgrastim, Ulcerative colitis, PASI, Intas Pharmaceuticals, Ustekinumab, Patient, Safety, Psoriasis, Medicine, BLA, Pharmaceutical industry

DURHAM, N.C., Jan. 4, 2024 /PRNewswire/ -- Accord BioPharma, Inc. the U.S. specialty division of Intas Pharmaceuticals Ltd. focused on development of oncology, immunology, and critical care therapies, announced today the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for DMB-3115. DMB-3115 is a proposed biosimilar to STELARA®, a blockbuster drug developed by Janssen Biotech, Inc. and approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. In the U.S., STELARA recorded $13.9 billion in sales (IQVIA Sales in 2022) and is one of the best-selling biologics.

Key Points: 
  • In the U.S., STELARA recorded $13.9 billion in sales (IQVIA Sales in 2022) and is one of the best-selling biologics.
  • The announcement of DMB-3115's BLA acceptance comes as Accord BioPharma awaits a string of additional regulatory milestones.
  • The company has submitted three separate Biologics License Applications to the FDA for biosimilar versions of trastuzumab, pegfilgrastim, and filgrastim.
  • Accord BioPharma is planning to introduce several additional biosimilars to the U.S. market during the next five years.

EQS-News: Formycon and Fresenius Kabi announce File Acceptance for FYB202, a biosimilar candidate to Stelara® (ustekinumab), by the U.S. Food and Drug Administration

Retrieved on: 
Saturday, December 30, 2023
Fresenius (company), Food, EMA, FDA, Biologics license application, Ulcerative colitis, Press release, Ustekinumab, Patient, Psoriasis, Biosimilar, BLA, Generic drug

Formycon and Fresenius Kabi announce File Acceptance for FYB202, a biosimilar candidate to Stelara® (ustekinumab), by the U.S. Food and Drug Administration

Key Points: 
  • Formycon and Fresenius Kabi announce File Acceptance for FYB202, a biosimilar candidate to Stelara® (ustekinumab), by the U.S. Food and Drug Administration
    The issuer is solely responsible for the content of this announcement.
  • Press Release // November 30, 2023
    Formycon and Fresenius Kabi announce File Acceptance for FYB202, a biosimilar candidate to Stelara® (ustekinumab), by the U.S. Food and Drug Administration
    Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its commercialization partner Fresenius Kabi today announced that the U.S. Food and Drug Administration (“FDA”) has accepted the Biologics License Application (“BLA”) for FYB202, a proposed biosimilar candidate to Stelara®1.
  • FYB202 is a human monoclonal antibody that targets interleukin 12 and interleukin 23 for the treatment of immune-mediated disorders.
  • “The FDA file acceptance for our Stelara® biosimilar candidate FYB202 underlines the great expertise and capabilities of #TeamFormycon.