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.

FDA/FTC Joint Workshop on a Competitive Marketplace for Biosimilars – Comments from Stakeholders

As we have previously reported, in February 2020 FDA and FTC announced a joint collaboration “to advance competition in the biologic marketplace.” On March 9th, the two agencies held a public workshop to discuss their “collaborative efforts to support appropriate adoption of biosimilars, discourage false or misleading statements about biosimilars, and…

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Federal Circuit Finds Pfizer’s RUXIENCE Plans Insufficient to Establish Standing to Appeal IPR

On April 27, 2020, the Federal Circuit issued a non-precedential opinion ruling that Pfizer failed to establish Article III standing in a pair of IPR appeals.  At the PTAB, Pfizer had challenged the validity of Chugai’s patents (7,332,289 and 7,927,815) covering processes relevant to the manufacture of rituximab.  In support…

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Xbrane Biopharma Plans to Continue Phase III Trial of its Xlucane® (Ranibizumab) Biosimilar Product

Swedish biotechnology company Xbrane Biopharma reports that, despite the difficulties posed by the Covid-19 pandemic, it will continue to recruit patients for the ongoing Phase III trial of its Xlucane® (ranibizumab) biosimilar product, and that it is still on track towards regulatory approval ahead of Lucentis® patent expiration in the…

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Supreme Court Narrows Scope of Judicial Review before the PTAB

The Supreme Court yesterday narrowed the scope of judicial review of proceedings before the Patent Trial and Appeal Board (PTAB) in Thryv, Inc. v. Click-to-Call Technologies, LP.  Thryv had petitioned the PTAB to institute an IPR of Click-to-Call‘s patent.  Thryv’s predecessor had been sued on that patent more than one…

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Samsung Bioepis and Merck Announce U.S. Launch of Trastuzumab Biosimilar

On Wednesday, Samsung Bioepis and Merck announced the U.S. launch of Ontruzant® (trastuzumab-dttb), a biosimilar to Herceptin® (trastuzumab).  Ontruzant® is indicated for the treatment of HER2-overexpressing breast cancer, and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, and is available in both 150 mg single-dose vials and 420 mg multiple-dose vials. …

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