Pegfilgrastim biosimilar - Biocon/Mylan

Drug Profile

Pegfilgrastim biosimilar - Biocon/Mylan

Alternative Names: Fulphila; MYL 1401H; PEG G CSF

Latest Information Update: 05 Dec 2017

Price : *
* Final gross price and currency may vary according to local VAT and billing address.

At a glance

  • Originator Biocon
  • Developer Biocon; Mylan
  • Class Chemoprotectants; Granulocyte colony-stimulating factors; Polyethylene glycols; Recombinant proteins
  • Mechanism of Action Granulocyte stimulants; Haematopoiesis stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Febrile neutropenia
  • Phase III Autoimmune disorders; Cancer

Most Recent Events

  • 30 Nov 2017 European Medicines Agency re-accepts MAA for pegfilgrastim biosimilar (Chemotherapy-induced) for Febrile neutropenia for review
  • 07 Nov 2017 Regulatory submission resumed for Febrile neutropenia (Chemotherapy-induced) in European Union (SC)
  • 10 Oct 2017 Mylan receives complete response letter from the FDA for pegfilgrastim biosimilar in Febrile neutropenia
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top