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Adello Biologics LLC

adellobio.com

Latest From Adello Biologics LLC

Pfizer Is King Of The US Biosimilar Hill

Four biosimilar candidates are under US FDA review, including what could be Pfizer’s eighth biologic approved under FDA’s 351(k) biologics license application pathway.

Biosimilars Approvals

US Biosimilars: FDA Seeks To Build On Record Number Of Approvals, But Shutdown May Blunt Progress

Past year was the high-water mark for product approvals and launches, but complete response letters remain a frequent occurrence. FDA’s ability to deliver on its promise of further clarity on transition products, interchangeability and indication carve-outs/carve-ins may take a hit from the ongoing partial government shutdown. On the legal side, look for more patent settlements with staggered entry dates and new antitrust scrutiny.

Biosimilars Biologics

2018 Complete Response Letters: Efficacy Issues Drove Most Product Rejections

US FDA issued at least seven rejections to novel products; opioid analgesic sponsors had very little success, while biosimilar developers had a so-so year.

Complete Response Letters Drug Review
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Company Information

  • Industry
  • Biotechnology
    • Large Molecule
  • Pharmaceuticals
  • Therapeutic Areas
  • Blood & Coagulation Disorders & Products
  • Cancer
  • Gastrointestinal
  • Inflammation
  • Musculoskeletal & Connective Tissue Disorders
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Adello Biologics LLC
  • Senior Management
  • Chintu Patel, CEO
    Chandramauli Rawal, MD, SVP, Operations
  • Contact Info
  • Adello Biologics LLC
    Phone: (732) 475-0500
    20 New England Ave.
    Piscataway, NJ 08854
    USA
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