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3 Things In Biotech You Should Learn Today: July 14, 2017

Jul. 14, 2017 10:00 AM ETAMGN, CTIC, INCY, VTRS, PLUR7 Comments
Zach Hartman profile picture
Zach Hartman


  • Biosimilars in oncology are go in the US.
  • CTI therapy for myelofibrosis now under review in Europe.
  • Pluristem cleared for enrollment in another country for its critical trial.

Welcome to another edition of "3 Things In Biotech You Should Learn Today," a daily digest dedicated to helping you keep up with the rapid-moving world of biotech and pharmaceutical research.

Let's dive in!

Biosimilars in oncology are go in the US

A few days ago, we briefly discussed the documents given to Mylan (MYL) and Amgen (AMGN) as they moved into meetings with their oncology drug advisory committees (ODACs) to address any concerns relating to their biosimilar monoclonal antibodies: trastuzumab and bevacizumab respectively.

If you recall, I mentioned that it didn't appear that there should be any issues with the ODAC. And this prediction has now born out, as both ODACs unanimously accepted for most of the indications that MYL and AMGN requested.

The only one that the ODAC opted out of here was bevacizumab for the management of ovarian cancer, because the two approvals Roche (OTCQX:RHHBY) has in these indications maintain patent exclusivity through their orphan drug designation.

Looking forward: Unsurprising, yet pivotal news for the oncology community. Biosimilars have been hotly anticipated for a long time because of their potential to provide the strong standard of care we've had access to for nearly 20 years, but at a significantly reduced cost outlay. As more biosimilar versions of trastuzumab and bevacizumab are given the nod from the FDA, it's going to be very interesting to see what the economic impact is.

CTI therapy for myelofibrosis now under review in Europe

CTI BioPharma (CTIC) has been in the business of developing pacritinib, an inhibitor of Janus kinase 2 that acts in a similar manner to Incyte's (INCY) blockbuster drug ruxolitinib.

However, pacritinib development has had a fitful development, with questions about the safety of this agent, as well as how it might compete in the same marketplace as INCY.

This article was written by

Zach Hartman profile picture
I am a former PhD scientist-turned-writer focused on cancer education. My writings in Seeking Alpha have been devoted to helping people identify promising investment opportunities in cancer research through commentary of recent events. Readers can learn more about other aspects of cancer research by visiting my site Invest Against Cancer.I also collaborate with Avisol Capital Partners on their Marketplace service known as the Total Pharma Tracker (TPT). Some of my work will be available to TPT subscribers either exclusively, or in advance. If you are interested, please click the link above!

Analyst’s Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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