As we previously reported, the FDA Oncologic Drugs Advisory Committee (“ODAC”) held a public meeting today regarding Hospira’s application for its proposed biosimilar of Amgen’s Epogen®/Procrit® (epoetin alfa). Pfizer, Hospira’s parent company, has announced today that ODAC recommended approval of their proposed epoetin alfa biosimilar across all indications. According to the press release,…
As we previously reported, the FDA announced that the Oncologic Drugs Advisory Committee (ODAC) will hold a public meeting on May 25, 2017 to discuss Hospira’s application for a proposed biosimilar of Amgen’s Epogen®/Procrit® (epoetin alfa). The FDA has now posted meetings materials associated with the May 25th meeting. The…
To view our full FDA Approvals tracking table, click here. Last updated: March 31, 2026
The FDA recently announced that the Oncologic Drugs Advisory Committee will hold a public meeting on May 25, 2017 to discuss Hospira’s application for a proposed biosimilar of Amgen’s Epogen®/Procrit® (epoetin alfa). Pfizer (Hospira’s parent) announced earlier this year that it resubmitted the application in December 2016, following FDA’s rejection…
On April 3, 2017, the Federal Circuit heard oral argument concerning the discovery dispute between Amgen and Hospira in their litigation concerning Hospira’s proposed biosimilar of Amgen’s product Epogen®/ Procrit® (epoetin alfa) (audio available here). In this dispute, Amgen is seeking to compel production of information concerning Hospira’s manufacturing process, including…
Below is our midwinter update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates (Summer 2016, Fall 2016).
Over the past week or so, several biologic and biosimilar companies have issued their year-end earnings reports. Below are some highlights on the biosimilar front: Pfizer recently reported in a press release announcing financial results for Q4 2016 that in December 2016 its subsidiary Hospira resubmitted its aBLA for Retacrit,…
Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2016: The FDA approved three biosimilar products in 2016, compared to only one in 2015 — Sandoz’s Zarxio®, a biosimilar version of Amgen’s Neupogen® (filgrastim). The first 2016 approval was Celltrion and Pfizer’s Inflectra®…
Below is our Fall 2016 update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly update (Summer 2016).
A recent meta-analysis investigated several factors impacting prescription drug costs in the United States. Doctors associated with the Brigham and Women’s Hospital and Harvard Medical School authored the report. Funding was provided by a grant from the Laura and John Arnold Foundation, with additional support from the Engelberg Foundation. The…