My Prediction for another Pfizer-Halo Target - not $10B PCSK9 market- only $9.3B
Amgen is Again Ahead of Pfizer- this time on Humira Biosimilar- HUMIRA is administered by subcutaneous injection.
I predict this will again be a target in which Pfizer uses Halozyme technology to gain an advantage on its leading competition.
The Amgen study will evaluate the safety and efficacy of Amgen’s biosimilar (ABP 501) versus AbbVie’s Humira in subjects with moderate to severe rheumatoid arthritis.
The trial is a multicentre, double-blind, randomized, active controlled, parallel-group study. The main objective of the study is to demonstrate equivalent efficacy of ABP 501 and Humira (adalimumab) in subjects with moderate to severe rheumatoid arthritis with respect to risk ratio of ACR20 (20% improvement in American College of Rheumatology core set measurements) at week 24.
The trial, which is expected to take 11 months, will be conducted in Argentina, Bulgaria, Canada, Czech Republic, Germany, Hungary, Mexico, Poland, Romania, Russia, Spain, UK and the US and will include 500 patients, aged 18 years and above.
AbbVie’s sales for Humira in 2012 were US$9.3 billion making it a lucrative target for biosimilars manufacturers. The patents on Humira expire in the European Union in 2016 and in the US in 2018 .
Pharma giant Pfizer has also started phase I study for its biosimilar adalimumab candidate (PF-06410293) according to the US clinical trials website, ClinicalTrials.
Should discuss RN316 the anti PCSK9 (LDL Rx) Target that Pfizer already mentioned in their CC- also since we know 2 targets were chosen- $8M was paid to HALO by PFE for them- I hope the second target is divulged- the topic of this post. They could update us on the 4 PegpH20 patients still "on study" as of last report in Sept, plus more on Yale research with Ultrafast Insulin and pump, And someone's going to ask Greg about HyQ's Baxter refiling- which BAX said would be "by year end"- Oh and a mention of Hylenex's growing market domination in anesthesia for eye surgery.
Study Of PF-06410293 And Adalimumab In Healthy Subjects (REFLECTIONS B538-01)
This study is currently recruiting participants.
Verified October 2013 by Pfizer
Information provided by (Responsible Party):
1st Pfizer must first establish the safety and comparative levels of their biosimilar to Brand- then I believe they add Rhuph20 and compare Again.