Welcome to the Big Molecule Watch!

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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.

Amgen petitions for rehearing en banc following Federal Circuit decision

On June 7, 2019, Amgen filed a petition for rehearing en banc of the Federal Circuit’s recent affirmance of summary judgment of non-infringement in favor of Sandoz in the BPCIA litigation regarding Sandoz’s ZARXIO (filgrastim-sndz) biosimilar and pegfilgrastim biosimilar candidate.  As we previously reported, on May 8, 2019, a Federal…

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Biosimilar and Follow-on Biologic Development Updates

Below are some highlights of recent news in biosimilar and follow-on biologic development: On June 14, Sandoz announced positive clinical study data regarding HYRIMOZ, its biosimilar of HUMIRA (adalimumab). According to Sandoz’s press release, data from a 48-week phase 3 clinical study demonstrated that switching from HUMIRA to HYRIMOZ provides…

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Bill Introduced to Limit Patent “Evergreening”

On June 11, Representatives Hakeem Jeffries (D-New York) and Doug Collins (R-Georgia) introduced a bipartisan bill with the stated purpose of addressing the rising cost of prescription drugs. According to the press release, the “Terminating the Extension of Rights Misappropriated (TERM) Act of 2019,” H.R. 3199, would “significantly limit[] the…

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Bevacizumab Litigation Update: Pfizer Answers Genentech’s Complaint and Genentech Moves to Dismiss Counterclaims

On April 29, 2019, Pfizer answered Genentech’s complaint alleging infringement of 22 patents based on Pfizer’s submission of an aBLA seeking U.S. FDA approval of a biosimilar of Avastin® (bevacizumab).  In its answer, Pfizer denied Genentech’s allegations of patent infringement and violations of the BPCIA’s patent dance procedures.  Pfizer also…

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FDA Approves Fifth Biosimilar of HERCEPTIN

Today, June 13, 2019, the U.S. FDA approved Amgen’s aBLA for KANJINTI (trastuzumab-anns), a biosimilar of Genentech’s HERCEPTIN. According to its approved package insert, KANJINTI, like its reference product, is indicated for the treatment of HER2 overexpressing breast cancer and the treatment of HER2 overexpressing metastatic gastric or gastroesophageal junction…

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Fresenius Kabi Files a Petition For Inter Partes Review of Amgen’s Pegfilgrastim Patent

On June 8, 2019, Fresenius Kabi filed a petition for inter partes review challenging the validity of U.S. Patent No. 9,643,997, entitled “Capture purification processes for proteins expressed in a non-mammalian system.”  The challenged claims in the patent, owned by Amgen Inc., relate to processes for purifying recombinant proteins expressed in a…

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Prescription Drug Prices Continue to Rise Despite Generics and Biosimilars

A recent analysis reveals that prescription drug prices continue to increase — even for drugs with FDA-approved therapeutic equivalents or biosimilar products. Dr. Nathan Wineinger evaluated the change in prescription drug prices over a 6-year period for the 49 top-selling brand-name medications in the United States. The price of 48…

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May 2019 FDA Guidance on Interchangeability Now Available

This month the FDA published its Guidance for Industry titled “Considerations in Demonstrating Interchangeability With a Reference Product”.  The guidance is “intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under…

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