Recombinant Human Granulocyte Colony-stimulating Factor（rhG-CSF）

EU Approves Aurobindo Pharma's Dyrupeg: New Pegfilgrastim Biosimilar for Chemotherapy Patients

2 months ago

• The European Commission has granted marketing authorization for Dyrupeg™, a pegylated filgrastim biosimilar developed by CuraTeQ Biologics, a subsidiary of Aurobindo Pharma. • Dyrupeg™ is indicated for reducing neutropenia duration and febrile neutropenia incidence in adult cancer patients undergoing cytotoxic chemotherapy, offering a cost-effective alternative to existing treatments. • The approval follows a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in January 2025, marking a significant expansion of Aurobindo's biosimilar portfolio in Europe.

Biosimilars Market Shows Mixed Progress: $36B in Savings Despite Adoption Challenges

3 months ago

• A decade after the first biosimilar approval, these drugs have generated $36 billion in healthcare savings, though adoption rates vary significantly across different molecules and therapeutic areas. • Market dynamics show complex patterns, with some biosimilars achieving up to 89% market share, while others struggle below 40%, influenced by PBM policies and brand-name manufacturer strategies. • The biosimilar landscape faces new challenges in 2025, with upcoming launches for Stelara and rare disease treatments, while PBM influence continues to shape market access and adoption patterns.

ImmunityBio's Anktiva Pursues European and UK Approval for BCG-Unresponsive Bladder Cancer

4 months ago

• ImmunityBio's Anktiva, combined with BCG, seeks approval in the EU and UK for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). • The MAAs submitted to the EMA and MHRA are supported by Phase 2/3 QUILT-3.032 trial data, demonstrating a 71% complete response rate in patients with NMIBC with CIS. • Regulatory assessments by both agencies are anticipated to conclude by Q4 2025, potentially leading to approval in Europe and the UK by 2026, expanding global access. • ImmunityBio also plans to submit a supplemental BLA to the FDA in 2025, seeking approval for Anktiva in patients with BCG-unresponsive NMIBC in the papillary indication.

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.

Experts Debate Optimal Sequencing of ADCs in HER2-Low Metastatic Breast Cancer Treatment

7 months ago

• Clinical experts favor trastuzumab deruxtecan (T-DXd) as first-line ADC therapy for HER2-low metastatic breast cancer, citing superior tolerability and impressive survival data. • Sacituzumab govitecan shows significant efficacy but presents management challenges with cytopenias, particularly in heavily pretreated patients, often requiring G-CSF support. • Back-to-back ADC administration appears effective, with experts noting no benefit to sandwiching conventional chemotherapy between ADC treatments.

FDA Approves Roche's Ocrevus (Zunovo) for Multiple Sclerosis

8 months ago

• The U.S. Food and Drug Administration (FDA) has approved Roche's Ocrevus (Zunovo) for the treatment of multiple sclerosis, offering a new therapeutic option. • Ocrevus, developed by Roche, represents a significant advancement in the treatment landscape for patients with relapsing and progressive forms of MS. • Roche's Ocrevus is part of a broad portfolio of pharmaceutical products targeting various disease areas, including immunology and neuroscience. • The approval underscores Roche's commitment to developing innovative medicines and diagnostic tools across a range of therapeutic areas.

FDA Approves Nypozi (filgrastim-txid) as Biosimilar to Neupogen

a year ago

• The FDA has approved Nypozi (filgrastim-txid), a biosimilar to Amgen's Neupogen, marking a significant milestone for Tanvex BioPharma, transitioning it into a commercial entity. • Nypozi is indicated to reduce infection incidence, particularly febrile neutropenia, in non-myeloid malignancy patients undergoing myelosuppressive anticancer treatments. • Filgrastim products, including Neupogen and biosimilars, generated over $400 million in sales in the U.S. in the 12 months leading up to March 2024. • Tanvex BioPharma launched Nypozi in Canada in January 2024, expanding its market presence prior to the U.S. FDA approval.

Fresenius Kabi Launches First Actemra® Biosimilar in U.S. Market as Biosimilar Landscape Expands

a year ago

• Fresenius Kabi has launched Tyenne® (tocilizumab-aazg), the first biosimilar of Actemra® to enter the U.S. market, following FDA approval in March 2024 for both intravenous and subcutaneous formulations. • Accord BioPharma received FDA approval for Hercessi™ (trastuzumab-strf), becoming the sixth Herceptin® biosimilar approved in the U.S., while Xbrane's Xlucane™ (ranibizumab) received a Complete Response Letter from the FDA. • The expanding biosimilar market continues to challenge reference products with significant annual sales, with Actemra® generating approximately $3 billion, Herceptin® $1.77 billion, and Lucentis® $1.475 billion in 2023.

Sandoz Marks Biosimilars Milestone with $1B Sales, Plans Five Major Launches by 2020

8 years ago

• Sandoz achieved a significant milestone in 2016, surpassing $1 billion in biopharmaceutical sales and celebrating the 10th anniversary of Europe's first biosimilar commercialization with Omnitrope. • The company's biosimilar Zarxio has exceeded $100 million in sales and overtaken its reference product Neupogen in volume market share in the US market. • Sandoz is committed to launching five major biosimilars across EU and US markets by 2020, with ongoing development of complex proteins and monoclonal antibodies.

FDA Approves Sandoz's Erelzi as First Enbrel Biosimilar in US

9 years ago

• Sandoz's Erelzi (etanercept-szzs) has received FDA approval as the first biosimilar to Amgen's Enbrel, covering all indications of the reference product for inflammatory diseases. • The approval marks a significant milestone in the US biosimilars landscape, potentially impacting the $5 billion annual US market for Enbrel. • The biosimilar approval aligns with healthcare cost reduction goals, with IMS Health projecting potential savings of up to $110 billion by 2020 across the US and five largest EU countries.

FDA Approves Record 45 New Drugs in 2015, Led by Breakthrough Cancer Immunotherapy Opdivo

9 years ago

• The FDA approved 45 new drugs in 2015, marking a significant rise in R&D productivity, with Bristol-Myers Squibb's immunotherapy Opdivo leading the pack with five new indications for various cancers. • Novel treatments like Vertex's Orkambi for cystic fibrosis and Novartis's Entresto for heart failure demonstrated remarkable clinical innovation, though pricing concerns remained central to industry discussions. • The year saw major developments in drug pricing debates, with the emergence of ICER as an independent US cost-effectiveness watchdog and increased scrutiny of pharmaceutical pricing practices.

Recombinant Human Granulocyte Colony-stimulating Factor（rhG-CSF）

Drug Development Updates