Conexiant
Login
  • The Analytical Scientist
  • The Cannabis Scientist
  • The Medicine Maker
  • The Ophthalmologist
  • The Pathologist
  • The Traditional Scientist
The Medicine Maker
  • Explore

    Explore

    • Latest
    • Features
    • Interviews
    • Business & Trends
    • Technology & Manufacturing
    • Product Profiles
    • White Papers

    Featured Topics

    • Biopharma
    • Small Molecules
    • Cell & Gene
    • Future of Pharma

    Issues

    • Latest Issue
    • Archive
    • Cell and Gene Therapy Supplement
  • Topics

    Topics

    • Drug Discovery
    • Development & Clinical
    • Formulation
    • Drug Delivery
    • Bioprocessing
    • Small Molecules
    • Cell and Gene
    • Facilities & Equipment
    • Outsourcing
    • Packaging
    • Supply Chain
    • Regulation & Standards
  • News & Blogs

    News & Blogs

    • Industry News
    • Research News
    • Blogs
  • Events
    • Live Events
    • Webinars
  • Community & Awards

    Community & Awards

    • Power List
    • Sitting Down With
    • Innovation Awards
    • Company of the Year Awards
    • Authors & Contributors
  • Multimedia
    • Video
    • Podcasts
    • eBooks
Subscribe
Subscribe
The Medicine Maker / Issues / 2020 / Articles / Aug / Biosimilars’ 2020 Breakthrough?
Business & Regulation Business Practice Standards & Regulation Biosimilars Regulation & Standards

Biosimilars’ 2020 Breakthrough?

FDA approves its first biosimilar of 2020

By Stephanie Vine 08/04/2020 0 min read Quick Read (pre 2022)

Share

The FDA has approved Pfizer’s Nyvepria (pegfilgrastim-apgf), a biosimilar of Amgen’s oncology supportive care drug, Neulasta. The approval is the FDA’s fourth for a biosimilar pegfilgrastim – and the first biosimilar approval for 2020. The drug, which is approved to prevent infection in patients receiving myelosuppressive anticancer drugs, has also been submitted to the EMA for review.

Although Pfizer plans to market the drug in the US later this year, Nyvepria is also the subject of ongoing litigation. Earlier this year, Amgen announced it was suing Pfizer over allegations that, when developing Nyvepria, Pfizer’s Hospira unit infringed on a Neulasta patent focusing on protein purification. Originally scheduled for June 2020, the trial has been postponed until May 2021. All previous biosimilar pegfilgrastim drugs have also faced lawsuits from Amgen.

Newsletters

Receive the latest analytical science news, personalities, education, and career development – weekly to your inbox.

Newsletter Signup Image

References

  1. Pfizer, “FDA Approves Pfizer’s Oncology Supportive Care Biosimilar, Nyvepria (Pegfilgrastim-apgf)” (2020). Available at https://bit.ly/2AbOY6T.
  2. FDANews, “Amgen Sues Pfizer, Hospira in Neulasta Patent Dispute” (2020). Available at https://bit.ly/2VqrIcY.

About the Author(s)

Stephanie Vine

Making great scientific magazines isn’t just about delivering knowledge and high quality content; it’s also about packaging these in the right words to ensure that someone is truly inspired by a topic. My passion is ensuring that our authors’ expertise is presented as a seamless and enjoyable reading experience, whether in print, in digital or on social media. I’ve spent fourteen years writing and editing features for scientific and manufacturing publications, and in making this content engaging and accessible without sacrificing its scientific integrity. There is nothing better than a magazine with great content that feels great to read.

More Articles by Stephanie Vine

False

Advertisement

Recommended

False

Related Content

What Trump’s Latest Moves Mean for the Industry
Business Practice Standards & Regulation Trends & Forecasts Bioprocessing - Upstream & Downstream
What Trump’s Latest Moves Mean for the Industry

May 27, 2025

6 min read

Audrey Greenberg’s latest insight on US-based manufacturing, Trump’s “Administration for A Healthy America”, and an ever-shifting regulatory environment.

Big Bad Pharma?
Business Practice Trends & Forecasts
Big Bad Pharma?

December 1, 2014

0 min read

The Ebola media frenzy has reminded the public how selfish our industry is. But, somehow, that doesn’t sound quite right...

Access All Areas
Business Practice Trends & Forecasts
Access All Areas

December 1, 2014

0 min read

The 2014 Access to Medicine index shows progress – but companies remain “conservative”

Care to ‘Patent Dance’?
Business Practice Trends & Forecasts
Care to ‘Patent Dance’?

December 1, 2014

0 min read

Amgen accuses Sandoz of snubbing its advances in a complex biosimilar dispute

The Medicine Maker
Subscribe

About

  • About Us
  • Work at Conexiant Europe
  • Terms and Conditions
  • Privacy Policy
  • Advertise With Us
  • Contact Us

Copyright © 2025 Texere Publishing Limited (trading as Conexiant), with registered number 08113419 whose registered office is at Booths No. 1, Booths Park, Chelford Road, Knutsford, England, WA16 8GS.