Denosumab

Amgen Reports Strong Global Demand in Q1 2025, Bolstering Long-Term Growth Outlook

20 days ago

• Amgen announced positive first quarter 2025 financial results, citing strong global demand across its product portfolio and successful new product launches. • Chairman and CEO Bob Bradway expressed confidence in Amgen's long-term growth prospects, supported by recent successful Phase 3 clinical trial results for several products. • The biotechnology company, which employs over 28,000 people globally, continues to focus on its mission of harnessing biology and technology to combat serious diseases.

Biocon Biologics Receives Positive CHMP Opinions for Denosumab Biosimilars in Europe

a month ago

• The Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Biocon Biologics' denosumab biosimilars, Vevzuo and Denosumab BBL, for bone health indications in Europe. • The positive opinions follow comprehensive data reviews demonstrating comparability with the reference product in pharmacokinetic, safety, efficacy, and immunogenicity profiles. • The European Commission will now review these recommendations before granting marketing authorizations, after which detailed information on approved indications will be published in official EU documentation.

2025 Pharmaceutical Pipeline: Major Patent Expirations Set to Transform Drug Market with Generics and Biosimilars

a month ago

• The US pharmaceutical market is poised for significant change in 2025 as several blockbuster drugs including Xarelto, Entresto, and Stelara face patent expirations, opening the door to generic and biosimilar competition. • Multiple biosimilars for ustekinumab (Stelara) are entering the market in 2025, with Wezlana already launched in January as the first interchangeable biosimilar, while other major drugs like ticagrelor and denosumab will also face competition. • The pharmaceutical pipeline continues to expand with innovative therapies for cancer and neurological disorders, alongside the Medicare Drug Price Negotiation program which will further impact pricing dynamics for high-cost medications.

EMA Proposes Streamlined Approval Process for Biosimilars to Enhance Patient Access

2 months ago

• The European Medicines Agency (EMA) has released a draft reflection paper outlining a simplified approval pathway for biosimilars that could reduce clinical data requirements while maintaining safety standards. • The proposed approach focuses on structural and functional comparability along with pharmacokinetic data, potentially eliminating the need for extensive clinical efficacy studies in biosimilar development. • If implemented in 2026 after the consultation period ends in September 2025, the streamlined process aims to increase market competition and improve patient access to critical biological treatments across the EU.

Celltrion's Phase 3 Study Validates Yuflyma's Interchangeability with Humira for Psoriasis Treatment

3 months ago

• A Phase 3 trial involving 367 Estonian patients demonstrated pharmacokinetic equivalence between Yuflyma and Humira in treating moderate to severe plaque psoriasis, with comparable efficacy and safety profiles. • Celltrion has submitted a supplemental application to the FDA in January 2024 seeking interchangeability status for Yuflyma, which could streamline the prescription switching process. • As the world's first high-concentration Humira biosimilar, Yuflyma offers advantages including reduced injection volume and citrate-free formulation, targeting a market where Humira generated $14.4 billion in global sales in 2024.

Cell Therapy and Targeted Therapies Dominate Oncology Advances in Early 2025

7 months ago

• The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD. • EsoBiotec dosed the first patient in a trial for ESO-T01, an in vivo BCMA-directed CAR-T therapy for multiple myeloma, aiming for lower costs and simplified administration. • Obecabtagene autoleucel (obe-cel) gained FDA approval for relapsed/refractory B-cell precursor ALL, offering a less toxic CD19-directed CAR T-cell therapy option. • Arlocabtagene autoleucel (arlo-cel) shows promise in heavily pretreated relapsed/refractory multiple myeloma, eliciting a 48% complete response rate in phase 1 studies.

US Biosimilar Market Set for $100 Billion Cost Reduction as Adoption Accelerates

4 years ago

• The US biosimilar market has shown significant growth with 20 approved products, projected to reduce drug costs by $100 billion over the next five years through increased competition and adoption. • Recent oncology biosimilars in bevacizumab, trastuzumab, and rituximab markets are achieving record market share, expected to reach 60% combined volume share within two years of launch. • Regulatory changes have expanded biosimilar categories to include 90 new molecules, with insulin biosimilars poised to enter the market and potentially transform diabetes care costs.