Dan Stanton, Managing editor

June 14, 2019

2 Min Read
America has 20 approved biosimilars but you’ll never believe how many have launched!
Amgen and Allergan's trastuzumab has become the 20th US biosimilar. Image: iStock/SADLERC1

With the FDA approving Amgen And Allergan’s version of Roche’s Herceptin (trastuzumab) America’s biosimilar tally has reached 20… But only seven have reached the market.

Clickbait headline aside, this week marks another major milestone in the US biosimilar market: the approval of its twentieth biosimilar Kanjinti (trastuzumab-anns), a version of Roche’s cancer monoclonal antibody Herceptin developed by Amgen and Allergan.

The approval is the third in Amgen’s portfolio and the second of four biosimilars from an Amgen and Allergan collaboration inked in 2011.


Amgen and Allergan’s trastuzumab has become the 20th US biosimilar. Image: iStock/SADLERC1

David Nicholson, chief research and development officer at Allergan, said in a statement: “We are proud of the progress being made as we continuously strive to develop and deliver high-quality cancer therapies in collaboration with Amgen.”

However, speaking last week at the Jefferies 2019 Healthcare Conference, Manisha Narasimhan, VP of Investor Relations and Strategic Initiatives said her firm’s biosimilar pipeline is a very small part of its business and “not top priority” among its 70 plus pharma and device programs.

Seven launches

Kanjinti becomes the fifth version of Trastuzumab to be approved, following versions from Mylan/Biocon, Celltrion, Merck/Samsung Bioepis and – most recently – Pfizer.

However, like the other trastuzumab molecules, legal wrangling and IP issues with Roche means there is no indication when Kanjiti will be launched.

Mylan, the first to receive US approval for a Herceptin biosimilar, has said it hopes to be the first to market after settling with Roche in 2017 in relation to patents for Herceptin, providing the firm with global licenses for its trastuzumab product. However, Mylan has not divulged if and when it will launch.

Meanwhile, the three approved Humira (adalimumab) biosimilars will not launch until at least 2023 after their respective marketing authority holders – Amgen, Boehringer Ingelheim and Sandoz – each reach an agreement over patent litigation with originator firm AbbVie. Other adalimumab developers have also inked similar settlements.

Of the 20 biosimilars approved, only seven are available to patients: Sandoz’s Zarxio (filgrastim-sndz), Celltrion/Pfizer’s Inflectra (infliximab-dyyb), Samsung Bioepis/Merck’s Renflexis (infliximab-abda), Pfizer’s Retacrit (epoetin alfa-epbx), Mylan and Biocon’s Fulphila (pegfilgrastim-jmdb), Coherus’ Udenyca (pegfilgrastim-cbqv) and Pfizer’s Nivestym (filgrastim-aafi).

Correction: This article has been updated to include Coherus’ Undenyca among the biosimilars that have so far been launched in the US. The Neulasta biosimilar launched in January 2019. The article has also been changed to reflect that seven biosimilars, rather than six, have been launched at he time of going to press.

About the Author(s)

Dan Stanton

Managing editor

Journalist covering the international biopharmaceutical manufacturing and processing industries.

Founder and editor of Bioprocess Insider, a daily news offshoot of publication Bioprocess International, with expertise in the pharmaceutical and healthcare sectors, in particular, the following niches: CROs, CDMOs, M&A, IPOs, biotech, bioprocessing methods and equipment, drug delivery, regulatory affairs and business development.

From London, UK originally but currently based in Montpellier, France through a round-a-bout adventure that has seen me live and work in Leeds (UK), London, New Zealand, and China.

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