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Ten Adalimumab Biosimilars Now Available in US Market Following Latest FDA Approval

3 months ago

• The FDA has approved ten adalimumab biosimilars, with Simlandi (adalimumab-ryvk) becoming the latest addition in February 2024, expanding treatment options for various autoimmune conditions. • Adalimumab biosimilars come in multiple concentrations and formulations, with some products achieving interchangeable status, offering potential cost savings while maintaining efficacy. • Pharmacists play a crucial role in managing these biosimilars, ensuring proper selection and administration while educating healthcare providers and patients about their safety and benefits.

Four New Humira Biosimilars Launch in US Market with Steep Discounts up to 85%

3 months ago

• Multiple pharmaceutical companies including Organon, Samsung Bioepis, Sandoz, and Boehringer Ingelheim launched Humira biosimilars in July 2023, offering significant price reductions compared to the original drug. • Boehringer Ingelheim's Cyltezo becomes the first FDA-approved interchangeable biosimilar to Humira, allowing direct substitution without requiring prescription changes. • The biosimilar launches come as AbbVie's Humira faces declining sales, with international revenues dropping 25% in Q1 2023 following the drug's $200 billion lifetime sales.

Global Biosimilars Market Set to Triple to $114 Billion by 2031, Driven by Patent Expirations and Cost Advantages

5 months ago

• The global biosimilars market is projected to grow from $36.01 billion in 2024 to $114.02 billion by 2031, representing a robust CAGR of 17.9%, fueled by increasing demand for cost-effective biologics. • Oncology biosimilars are emerging as a particularly strong segment, expected to reach $35.79 billion by 2034 with an 18.6% CAGR, as patent expirations of blockbuster cancer drugs create new market opportunities. • Regulatory support from agencies like FDA and EMA is accelerating biosimilar adoption, with recombinant human growth hormone and granulocyte colony-stimulating factor segments leading market growth across therapeutic areas.

FDA Approves Steqeyma and Yesintek: Expanding Biosimilar Options for Stelara

6 months ago

• The FDA has approved Steqeyma (ustekinumab-stba) and Yesintek (ustekinumab-kfce) as biosimilars to Stelara, offering new options for patients with autoimmune and inflammatory conditions. • Steqeyma and Yesintek are approved for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, mirroring Stelara's indications. • These approvals are expected to increase market competition and reduce treatment costs, with launches anticipated in early 2025 following licensing agreements.

Skyrizi Outpaces Humira in US Sales Amid Biosimilar Competition

6 months ago

• Skyrizi (risankizumab-rzaa) has surpassed Humira (adalimumab) in U.S. sales, marking a shift in the immunology market after biosimilar introduction. • Humira's global revenues declined by 37.2%, with U.S. sales dropping 41.6%, while Skyrizi saw a 50.8% global increase in the third quarter of 2024. • "Product hopping," where companies shift demand to newer, patented drugs, complicates the biosimilar market and hinders price competition. • Policy reforms and greater transparency in PBM practices are advocated to improve biosimilar access and foster a competitive market.

Boehringer Ingelheim Plans 25 New Treatments by 2030, Bolstered by Oncology and Metabolic Disease Programs

a year ago

• Boehringer Ingelheim aims to launch 25 new treatments by 2030, focusing on oncology, mental health, cardiovascular, renal, and metabolic diseases. • Key candidates include Brigimadlin, an MDM2-p53 agonist for dedifferentiated liposarcoma, and zongertinib, a HER2 tyrosine kinase inhibitor, showing promising early data. • Survodutide, a glucagon/GLP-1 candidate, demonstrated significant improvement in liver disease due to metabolic dysfunction-associated steatohepatitis in Phase II trials. • Despite slow sales of its Humira biosimilar, Cyltezo, Boehringer reported a 9.7% net sales increase in 2023, driven by Jardiance and Ofev.

Celltrion Pursues Adalimumab Interchangeability as Formycon Reports Positive Ustekinumab Biosimilar Data

3 years ago

• Celltrion Healthcare has filed an investigational new drug application with the FDA for a Phase 3 clinical trial to establish interchangeability of its adalimumab biosimilar, Yuflyma, with Humira. • The Phase 3 trial will involve switching patients between Humira and Yuflyma to verify pharmacokinetics, efficacy, and safety in 366 patients with plaque psoriasis. • Formycon announced positive Phase 3 data for its ustekinumab biosimilar (FYB202), demonstrating comparable efficacy and safety to Stelara in patients with moderate to severe plaque psoriasis. • The Formycon study met its primary endpoint, showing comparable improvement in Psoriasis Area and Severity Index scores after 12 weeks, with no clinically meaningful differences in adverse events.

FDA Approves Two New Ustekinumab Biosimilars, Bringing Total US Biosimilar Count to 65

10 years ago

• The FDA has approved Biocon's Yesintek (ustekinumab-kfce) and Celltrion's Steqeyma (ustekinumab-stba) in November and December 2024, expanding treatment options for autoimmune conditions including Crohn's disease and psoriasis. • Of the 65 FDA-approved biosimilars, 14 have received interchangeable designation, allowing pharmacists to substitute them for reference products without prescriber intervention, enhancing patient access to more affordable treatments. • The biosimilar landscape continues to evolve with products spanning five major classes: insulin, granulocyte colony-stimulating factors, monoclonal antibodies, TNF-alpha inhibitors, and VEGF inhibitors.

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Drug Development Updates