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Biocon Ltd.

www.biocon.com

Latest From Biocon Ltd.

US Marks Biologics Transition Day

Sanofi’s Lantus stands alone as the only insulin product still listed in the ‘Orange Book’ post-transition because it is referenced in Mylan/Biocon’s pending 505(b)(2) application for insulin glargine; the FDA said it stands ready to review biosimilar and interchangeable applications that reference the newly ‘deemed’ biologic products.

Regulation Review Pathway

Transition Day In The US: 96 Drugs Make The Move To Biologics Regulation

Sanofi’s Lantus stands alone as the only insulin product still listed in the ‘Orange Book’ post-transition because it is referenced in Mylan/Biocon’s pending 505(b)(2) application for insulin glargine; the FDA said it stands ready to review biosimilar and interchangeable applications that reference the newly ‘deemed’ biologic products.

Biologics Biosimilars

New Patent Litigation Playbook For Products Switching To Biologics

Innovators are losing the protections of ANDA litigation as their products transition from drugs to biologics; both sides in patent disputes will now adopt different strategies.

Biologics Biosimilars

FDA And FTC Offer Advice On Biosimilar Barriers

Speakers suggest ways to eliminate barriers to biosimilar uptake, but Janssen pushes back, saying there is need to inform physicians and patients of a biosimilar's interchangeability status. Biosimilar advocates want prescriber incentives, labeling changes, and FDA education on interchangeability.

Biosimilars FDA
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Company Information

  • Industry
  • Biotechnology
    • Large Molecule
      • Antibodies
  • Medical Devices
  • Pharmaceuticals
  • Services
  • Therapeutic Areas
  • Non-Specific
  • Alias(es)
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • Asia
      • India
  • Parent & Subsidiaries
  • Biocon Ltd.
  • Senior Management
  • Arun Chandavarkar, PhD, CEO
    Siddharth Mittal, CFO
    Ravi Limaye, Pres., Mktg.
    Narendra Chirmule, PhD, SVP & Head, R&D
  • Contact Info
  • Biocon Ltd.
    Phone: (91) 80 2808 2808
    20th KM Hosur Rd.
    Electronic City
    Bangalore , 560 100
    India
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