Welcome to the Big Molecule Watch!
Big Molecule Watch will be posting updates and analyses on regulatory issues, litigation, legislation, and other news in the ever-developing world of biosimilars. The editors of this blog have collectively been watching and engaging with the world of biosimilars (“big molecules”) since before the inception of the biosimilar industry in the U.S., and we’re excited to share the observations of our active watch on this new forum.
If you’re looking for a primer on biologics, check out our background post
introducing the world of biologics, biosimilars, and the Biologics Price Competition and Innovation Act (“BPCIA”).
We’ve also collected (and will continue to update) some reference documents that might be of interest to visitors of this blog—you can find them under the “Links” section to the right of this page.
With the Supreme Court’s pending decision
in Sandoz v. Amgen
, the interpretation of the patent dance provisions of the BPCIA has been a hot topic here on the blog. For an in-depth analysis of […]
In the past few days, Pfizer has filed petitions for IPR of two of Biogen’s patents related to rituximab: IPR2017-01166
on U.S. Patent 8,329,172 and IPR2017-01167
on U.S. Patent 8,577,244. According to the […]
Last week, Apotex filed a Citizen Petition
requesting that FDA “take certain actions to ensure a robust approval process” for proposed biosimilars to Amgen’s Neulasta (pegfilgrastim). Among its requests, Apotex asks that FDA require each biosimilar […]
On Monday, April 24, 2017, Fresenius Kabi and Merck KGaA announced that Fresenius will be acquiring Merck KGaA’s biosimilars business. According to Merck KGaA’s press release, Merck KGaA’s biosimilar portfolio focuses on oncology and inflammatory […]
The transcript of today’s Supreme Court oral argument in Sandoz v. Amgen
has been posted online and is available here
. As we covered
briefly this morning, the questioning during today’s argument focused primarily […]
The Supreme Court held a 70-minute oral argument in Sandoz v. Amgen
this morning. Before beginning the argument, the Chief Justice announced that the Court would give each side five extra minutes–a highly unusual step reflecting […]
As a reminder to our readers, tomorrow the Supreme Court will hear oral arguments in Amgen v. Sandoz
regarding the following questions: Whether a biosimilar applicant is required by 42 U.S.C. § 262(l
)(2)(A) to provide […]
In a press release
, Glenmark Pharmaceuticals announced today that the U.S. FDA has cleared Glenmark’s Investigational New Drug (IND) application of GBR 310, a proposed biosimilar of XOLAIR® (omalizumab), to initiate a first-in-human pharmacokinetics […]
On Friday, April 21, 2017, Sandoz announced
that the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sandoz’s biosimilars rituximab and etanercept in Europe. If approved, rituximab may be […]
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 […]