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.

Xbrane Shifts Strategic Focus to Biosimilars

Today, September 10, 2018, Xbrane Biopharma announced that it has decided to shift its strategic focus of capital and resources toward biosimilars and away from its pipeline of generic long-acting injectables.  In addition to moving forward with its pivotal clinical trial for Xlucane, its proposed biosimilar of Lucentis® (ranibizumab), Xbrane…

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Biologic and Biosimilar Litigation Updates

Below we provide updates in three pending litigations. First, in an update on the Amgen v. Coherus appeal regarding Coherus’s biosimilar application for pegfilgrastim, Amgen filed its opening brief on August 20. Amgen’s statement of the issues reads: 1. Whether the district court erred in dismissing Amgen’s Complaint, with prejudice, based…

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New BPCIA Complaint: Genentech Sues Samsung Bioepis Regarding Proposed Trastuzumab Biosimilar (UPDATED)

Yesterday, September 4, 2018, Genentech filed a complaint against Samsung Bioepis in the District of Delaware alleging infringement under the BPCIA of 21 patents based on Bioepis’s filing of an aBLA for SB3, a biosimilar candidate referencing Herceptin® (trastuzumab).  This is the fourth litigation regarding a biosimilar of Herceptin®, following…

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Biosimilar and Biologic Development Updates

On Wednesday, Celltrion announced its completion of its Phase 3 clinical trial for Remsima SC, a subcutaneous version of its biosimilar Remsima® (infliximab).  According to Celltrion, “[t]he subcutaneous formulation allows patients to conveniently inject it by themselves according to the administration cycle unlike the intravenous formulation that require patients to…

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Litigation Update:  Sanofi’s Summary Judgment Motion Denied, Immunex Renews Its Motion to Stay Pending IPR in DUPIXENT Patent Litigation

Following up on our previous coverage of Immunex’s patent infringement suit against Sanofi related to Immunex’s Dupixent® (dupilumab) biologic, Judge Otero recently denied Sanofi’s motion for summary judgement of invalidity based on indefiniteness of the claim terms “competes” and “binding affinity (Ka).” Sanofi criticized Immunex’s ’487 patent for failing to…

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Pfizer Submits Citizen Petition to FDA Regarding Communications About Biosimilars

On August 22, 2018, Pfizer submitted a citizen petition to the Food and Drug Administration requesting “guidance clarifying appropriate sponsor communications about the nature and properties of biosimilar products.”  Specifically, Pfizer petitioned FDA to clarify what constitutes a false and misleading communication with respect to the safety and effectiveness of biosimilars relative…

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Janssen Appeals District Court’s Summary Judgment of Non-Infringement in INFLECTRA Litigation (UPDATED)

As we have previously covered, last month the court in Janssen v. Celltrion (D. Mass., J. Wolf) issued a memorandum opinion granting Celltrion’s motion for summary judgment of non-infringement of the sole remaining patent-in-suit, and the next day entered final judgment for Celltrion. The court subsequently entered an amended final judgment to dismiss without prejudice Celltrion’s…

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BREAKING NEWS: Jury’s $70M Award Against Hospira for Infringing Amgen's Epoetin Patent Survives Post-Trial Motions

As we previously reported, last September a District of Delaware jury issued a verdict that Hospira’s manufacture of 14 batches of drug substance in connection with its proposed biosimilar of Amgen’s Epogen® (epoetin alfa) was not protected activity under the § 271(e)(1) safe harbor and infringed Amgen’s ’298 patent, and…

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BMS and Momenta File Additional Letters Regarding Standing in Orencia IPR Appeal

As we reported here, Momenta is appealing a PTAB decision upholding the patentability of BMS’s U.S. Patent No. 8,476,239 (“the ’239 patent”), which relate to BMS’s Orencia® (abatacept) product.  Momenta has not yet filed an aBLA for its abatacept biosimilar candidate, M834, so one of the key issues on appeal is whether Momenta has Article III standing…

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