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.

Proposed Amendment to Hatch-Waxman and BPCIA Could Curb IPRs by Generic and Biosimilar Applicants

On June 13, Senator Orrin Hatch (R-UT), co-author of the Drug Price Competition and Patent Term Restoration Act (aka the “Hatch-Waxman Act”), proposed an amendment in the Senate Judiciary Committee to modify the inter partes review (IPR) process for pharmaceuticals.  The amendment, titled the Hatch-Waxman Integrity Act of 2018, would require aBLA…

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Big Molecule Watch Editor Nick Mitrokostas to Speak at ACI Annual Biosimilars Summit

On June 25-June 27th, at the Intercontinental New York Times Square, industry leaders from both innovator and biosimilar companies will convene at ACI’s 9th Annual Summit on Biosimilars to discuss the future of biosimilars and formulate solutions to the complex regulatory and patent challenges ahead. Goodwin is a proud sponsor…

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Updates On Discovery Rulings in AbbVie v. BI Adalimumab Litigation

We have recently reported on multiple discovery rulings in the ongoing AbbVie v. Boehringer Ingelheim litigation concerning Boehringer Ingelheims’s (“BI’s”) aBLA for Cyltezo™ (adalimumab-adbm), a biosimilar version of AbbVie’s Humira® (adalimumab) product.  On June 14, 2018, Magistrate Judge Lloret issued two additional opinions regarding discovery in the case. In the first opinion, the Court granted-in-part…

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Lupin and Nichi-Iko Collaborate to Market Etanercept Biosimilar in Japan

As we reported last month, YL Biologics (a joint venture between Lupin’s subsidiary Kyowa and Yoshindo) recently submitted a New Drug Application (NDA) for Marketing Authorization of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for YLB113, a proposed biosimilar of Enbrel® (etanercept). Yesterday, Lupin and Nichi-Iko Pharmaceutical announced that they…

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IPR Updates: Trastuzumab, Rituximab, Abatacept

Below are a few recent updates in IPR proceedings concerning biologic-related patents: Today, the Board denied Samsung Bioepis’ petition for IPR of Genentech’s U.S. Patent No. 7,846,441 (IPR2017-00192), directed to cancer treatment methods using trastuzumab.  In its decision, the Board explained that it was exercising its discretion to deny the petition in…

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Celltrion Healthcare Presents Research Demonstrating Positive Results for Use of Biosimilar Infliximab in Treatment of Crohn’s Disease and Rheumatoid Arthritis

Celltrion Healthcare recently presented research from two studies conducted on its CT-P13 subcutaneous (SC) formulation (biosimilar infliximab) demonstrating positive results for the use of CT-P13 SC in the treatment of active Crohn’s disease and rheumatoid arthritis.  According to Celltrion, the data from each study shows the efficacy and safety of…

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Samsung Bioepis and Biogen Announce Pooled Analysis of Three Anti-TNF Biosimilars

Yesterday, Samsung Bioepis and Biogen announced pooled analysis results that will be presented this week at the 2018 Annual European Congress of Rheumatology (EULAR). Data from three separate Phase III randomized, double-blinded studies compared the safety and efficacy of BENEPALI (SB4, etanercept biosimilar); FLIXABI (SB2, infliximab biosimilar); and IMRALDI (SB5,…

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Updates On Discovery Rulings in AbbVie v. BI Adalimumab Litigation

We have covered the ongoing AbbVie v. Boehringer Ingelheim litigation concerning Boehringer Ingelheims’s (“BI’s”) aBLA for Cyltezo™ (adalimumab-adbm), a biosimilar version of AbbVie’s Humira® (adalimumab) product, including the grant of a recent motion to compel discovery regarding BI’s unclean hands defense.  Magistrate Judge Lloret issued two additional orders regarding discovery in that case….

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New IPR Petitions Filed Against GSK Vaccine Process Patents

Yesterday, Merck Sharp & Dohme Corp. filed four IPR petitions (IPR2018-01229,  IPR2018-01236, IPR2018-01234, and IPR2018-01237) against GlaxoSmithKline process patents – US Patent Nos. 8,753,645 and 9,265,839. The ‘645 and ‘839 Patents are directed towards a process of conjugating bacterial saccharides to protein carriers in order to improve the immunogenicity of…

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Samsung Bioepis Reports One-Year Follow-Up Results for Trastuzumab Biosimilar

According to an announcement by Samsung Bioepis, an additional one-year follow-up study on SB3, a biosimilar candidate referencing Herceptin® (trastuzumab), showed low incidence of cardiac safety events and no statistically significant difference in survival results compared to trastuzumab in patients with HER2-positive early or locally advanced breast cancer. The data…

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