Big Molecule Watch

• Accused Biosimilar: M710 (aflibercept)
• Marketing Status: Not approved
• Reference Product: EYLEA
• Complaint Filed: Aug. 2, 2022
• Litigation Status/Outcome:  Pending
  • An expedited trial was held in June 2023.  Post-trial briefing is underway.  The Court has not yet issued an opinion.

• Accused Biosimilar: Denosumab biosimilar
• Marketing Status: Not approved
• Reference Product: XGEVA, PROLIA
• Complaint Filed: May 1, 2023
• Litigation Status/Outcome:  Pending
  • On September 5, 2023, the Court entered an amended scheduling order.
  • On September 8, 2023, Amgen filed a motion for preliminary injunction.  An evidentiary hearing on Amgen’s motion is scheduled to start on October 30, 2023.

• Accused Biosimilar: PB006 (natalizumab)
• Marketing Status: Not approved
• Reference Product: TYSABRI
• Complaint Filed: Sept. 9, 2022
• :Litigation Status/Outcome:  Pending
  • On October 19, 2022, Biogen filed a Motion for Preliminary Injunction.  Oral argument was held on May 17, 2023.  On June 20, 2023, in a sealed filing, the Court denied Biogen’s Motion for Preliminary Injunction.  On June 27, 2023, the Court filed a redacted version of its order.  The Court held that Biogen did not satisfy its burden to show two requirements: (1) that it would suffer irreparable harm in the absence of an injunction and (2) that it would likely succeed on the merits.
  • On August 25, 2023, the Court issued a Scheduling Order.  The case is set for trial beginning on May 5, 2025.

• Accused Biosimilar: BIIB800 (tocilizumab)
• Marketing Status: Not approved
• Reference Product: ACTEMRA
• Complaint Filed: July 13, 2023
• Litigation Status/Outcome:  Pending

• Accused Biosimilar: AMJEVITA (adalimumab-atto)
• Marketing Status: Approved by FDA on September 23, 2016; launched in US on January 31, 2023
• Reference Product: HUMIRA
• Complaint Filed: Aug. 4, 2016
• Litigation Status/Outcome
  • On September 28, 2017, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

AbbVie v. Boehringer Ingelheim, No. 17-1065 (D. Del.)

• Accused Biosimilar: CYLTEZO (adalimumab-adbm)
• Marketing Status: Approved by FDA on August 25, 2017; not yet launched in US
• Reference Product: HUMIRA
• Complaint Filed: Aug. 2, 2017
• Litigation Status/Outcome
  • On May 15, 2019, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

AbbVie v. Sandoz, No. 18-12668 (D.N.J.)

• Accused Biosimilar: HYRIMOZ (adalimumab-adaz)
• Marketing Status: Approved by FDA on October 30, 2018; not yet launched in US
• Reference Product: HUMIRA
• Complaint Filed: Aug. 10, 2018
• Litigation Status/Outcome
  • On October 16, 2018, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

AbbVie v. Alvotech, No. 21-2258, 21-2899 (N.D. Ill.)

• Accused Biosimilar: AVT02 (adalimumab)
• Marketing Status: Not approved
• Reference Product: HUMIRA
• Complaint Filed: April 27, 2021, May 28, 2021
• Litigation Status/Outcome
  • On March 9, 2022, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Alvotech USA v. Abbvie, No. 2-21-00265 (E.D. Va.)

• Accused Biosimilar: ATV02 (adalimumab)
• Marketing Status: Not approved
• Reference Product: HUMIRA
• Complaint Filed: May 11, 2021 – Declaratory judgment claims filed by Alvotech for non-infringement, invalidity, and unenforceability of Abbvie patents
• Litigation Status/Outcome:
  • On Oct. 22, 2021, the court granted Alvotech’s motion to transfer venue to the N.D. of Illinois.  Upon transfer to the N.D. Illinois, the case (No. 1-21-cv-05645) was voluntarily dismissed.

Genentech v. Amgen, Nos. 17-1407, -1471, 19-602 (D. Del.)

• Accused Biosimilar: MVASI (bevacizumab-awwb)
• Marketing Status: Approved by FDA on September 14, 2017; launched in US on July 18, 2019
• Reference Product: AVASTIN
• Complaint Filed: Oct. 6, 2017
• Litigation Status/Outcome
  • On July 19, 2019, the district court denied Genentech’s motions for a preliminary injunction and temporary restraining order.
    • Appeal: Genentech v. Amgen, 964 F.3d 1109 (Fed. Cir. 2020) (affirming on interlocutory appeal)
  • On July 7, 2020, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Genentech v. Pfizer, No. 19-638 (D. Del.)

• Accused Biosimilar: ZIRABEV (bevacizumab-bvzr)
• Marketing Status: Approved by FDA on June 28, 2019; launched in US on December 31, 2019
• Reference Product: AVASTIN
• Complaint Filed: Apr. 5, 2019
• Litigation Status/Outcome
  • On September 20, 2019, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Genentech v. Centus, No. 20-361 (E.D. Tex.)

• Accused Biosimilar: FKB238 (bevacizumab)
• Marketing Status: Not approved
• Reference Product: AVASTIN
• Complaint Filed: November 12, 2020
• Litigation Status/Outcome
  • On July 2, 2021, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Genentech v. Samsung Bioepis, No. 20-859 (D. Del.)

• Accused Biosimilar: SB8 (bevacizumab)
• Marketing Status: Not approved
• Reference Product: AVASTIN
• Complaint Filed: June 28, 2020
• Litigation Status/Outcome
  • Voluntarily Dismissed on Sept. 7, 2022.

Amgen v. Hospira, No. 15-839 (D. Del.)

• Accused Biosimilar: RETACRIT (epoetin alfa-epbx)
• Marketing Status: Approved by FDA on May 15, 2018; launched in US on November 12, 2018
• Reference Product: EPOGEN/ PROCRIT
• Complaint Filed: Sept. 18, 2015
• Litigation Status/Outcome
  • On September 22, 2017, the jury found that Hospira infringed the ’298 patent and awarded Amgen $70M. On August 27, 2018, the district court denied Hospira’s post-trial motion for judgment as a matter of law of no infringement and invalidity, or, in the alternative, a new trial or recalculation of damages.
  • Appeal: Amgen v. Hospira, 944 F.3d 1327 (Fed. Cir. 2019) (affirming judgment), rehearing denied, No. 19-1067 (Fed. Cir. Mar. 16, 2020).

Immunex v. Sandoz, No. 16-01118 (D.N.J.)

• Accused Biosimilar: ERELZI (etanercept-szzs)
• Marketing Status: Approved by FDA on August 30, 2016; not yet launched in US
• Reference Product: ENBREL
• Complaint Filed: Feb. 26, 2016
• Litigation Status/Outcome
  • On August 9, 2019, the district court held that the ’182 and ’522 patents were not invalid. Sandoz did not contest infringement of the patents.
  • Appeal: Immunex v. Sandoz, 964 F.3d 1049 (Fed. Cir. 2020) (affirming judgment).

Immunex v. Samsung Bioepis, No. 19-11755 (D.N.J.)

• Accused Biosimilar: ETICOVO (etanercept-ykro)
• Marketing Status: Approved by FDA on April 25, 2019; not yet launched in US
• Reference Product: ENBREL
• Complaint Filed: Apr. 29, 2019
• Litigation Status/Outcome
  • On November 3, 2021, the district court entered a final judgment and order of permanent injunction in favor of Immunex on each of its claims for infringement of the ’182 and ’522 patents. Not appealed.

Amgen v. Sandoz, No. 14-4741 (N.D. Cal.)

• Accused Biosimilar: ZARXIO (filgrastim-sndz)
• Marketing Status: Approved by FDA on March 6, 2015; launched in US on Sept. 3, 2015
• Reference Product: NEUPOGEN
• Complaint Filed: Oct. 24, 2014
• Litigation Status/Outcome
  • On March 19, 2015, the district court denied Amgen’s motion for preliminary injunction and motion for partial judgment of the pleadings, finding that the patent dance is not mandatory and that notice of commercial marketing (NCM) may be provided prior to FDA approval. The district court also dismissed Amgen’s state law claims.
    • Appeal: Amgen v. Sandoz, 794 F.3d 1347 (Fed. Cir. 2015) (holding that patent dance is not mandatory and NCM can only be provided after FDA approval, and affirming dismissal of state law claims), rev’d in part, aff’d in part, 137 S. Ct. 1664 (2017) (holding that compliance with patent dance provision (l)(2)(A) of the BPCIA  cannot be compelled under federal law and that NCM can be provided prior to FDA approval, and vacating judgment on state law claim for further consideration); on remand to Federal Circuit, 877 F.3d 1315 (Fed. Cir. 2017) (affirming dismissal of state law claims on preemption grounds).
  • On September 3, 2017, the district court entered a stipulation of non-infringement of the ‘427 patent.
  • On December 9, 2017, the district court granted summary judgment of non-infringement of the ‘878 patent in favor of Sandoz.
    • Appeal: Amgen v. Sandoz, 923 F.3d 1023 (Fed. Cir. 2019) (affirming grant of summary judgment), as modified by 776 F. App’x 707 (Fed. Cir. 2019).

Amgen v. Apotex, No. 15-62081 (S.D. Fla.)

• Accused Biosimilar: GRASTOFIL (filgrastim)
• Marketing Status: Not approved
• Reference Product: NEUPOGEN
• Complaint Filed: Oct. 2, 2015
• Litigation Status/Outcome
  • On September 6, 2016, the district court ruled that Apotex’s proposed biosimilar would not infringe the asserted claims of the ’138 patent.
    • Appeal: Amgen v. Apotex, 712 F. App’x 985 (Fed. Cir. 2017) (affirming judgment of non-infringement).

Amgen v. Kashiv (formerly Adello), No. 18-3347 (D.N.J.)

• Accused Biosimilar: TPI G-CSF (filgrastim)
• Marketing Status: Not approved
• Reference Product: NEUPOGEN
• Complaint Filed: Mar. 8, 2018
• Litigation Status/Outcome
  • On November 25, 2019, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Amgen v. Hospira, Nos. 18-1064, 20-561 (D. Del.)

• Accused Biosimilar: NIVESTYM (filgrastim-aafi)
• Marketing Status: Approved by FDA on July 20, 2018; launched in US on October 1, 2018
• Reference Product: NEUPOGEN
• Complaint Filed: July 18, 2018
• Litigation Status/Outcome
  • On September 8, 2021, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Amgen v. Tanvex, No. 19-1374 (S.D. Cal.)

• Accused Biosimilar: TX-01 (filgrastim)
• Marketing Status: Not approved
• Reference Product: NEUPOGEN
• Complaint Filed: July 23, 2019
• Litigation Status/Outcome
  • On December 20, 2019, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Janssen v. Celltrion, No. 17-11008 (D. Mass.)

• Accused Biosimilar: INFLECTRA (infliximab-dyyb)
• Marketing Status: Approved by FDA on April 5, 2016; launched in US on November 28, 2016
• Reference Product: REMICADE
• Complaint Filed: Mar. 6, 2015 (refiled May 31, 2017)
• Litigation Status/Outcome
  • On July 30, 2018, the district court granted summary judgment of invalidity as to the ’471 patent and further granted summary judgment of non-infringement as to the ’083 patent.
    • Appeal: Janssen v. Celltrion, 796 F. App’x 741 (Fed. Cir. 2020) (affirming judgment of invalidity of the ’083 patent without opinion pursuant to Fed. Cir. R. 36) (appeal of the judgment as to the ’471 patent was dismissed as moot in light of the Federal Circuit’s affirming the PTAB’s invalidation of the patent during ex parte reexamination).

Janssen v. Samsung Bioepis, No. 17-3524 (D.N.J.)

• Accused Biosimilar: RENFLEXIS (infliximab-abda)
• Marketing Status: Approved by FDA on April 21, 2017; launched in US on July 24, 2017
• Reference Product: REMICADE
• Complaint Filed: May 17, 2017
• Litigation Status/Outcome
  • On November 30, 2017, the district court entered a stipulation of voluntary dismissal in light of Janssen’s proposal and Samsung’s consent to dismiss of all remaining counts of the complaint.

Amgen v. Apotex, No. 15-61631 (S.D. Fla.)

• Accused Biosimilar: LAPELGA (pegfilgrastim biosimilar)
• Marketing Status: Not approved
• Reference Product: NEULASTA
• Complaint Filed: Aug. 6, 2015
• Litigation Status/Outcome
  • On December 10, 2015, the district court granted Amgen’s motion for a preliminary injunction, preventing Apotex from marketing its biosimilar product until 180 days after Apotex notifies Amgen that its biosimilar application has received FDA approval and that Apotex intends to begin commercial marketing.
    • Appeal: Amgen v. Apotex, 827 F.3d 1052 (Fed. Cir. 2016) (affirming grant of injunction), cert. denied, 137 S. Ct. 591 (2016).
  • On September 6, 2016, the district court ruled that Apotex’s proposed biosimilar would not infringe the asserted claims of the ’138 patent.
    • Appeal: Amgen v. Apotex, 712 F. App’x 985 (Fed. Cir. 2017) (affirming judgment of non-infringement).

Amgen v. Sandoz, No. 16-2581 (N.D. Cal.)

• Accused Biosimilar: ZIEXTENZO (pegfilgrastim-bmez)
• Marketing Status: Approved by FDA on November 4, 2019; launched in US on December 2, 2019
• Reference Product: NEULASTA
• Complaint Filed: Mar. 4, 2016
• Litigation Status/Outcome
  • On December 19, 2017, the district court granted summary judgment of non-infringement of the ’878 patent in favor of Sandoz.
    • Appeal: Amgen v. Sandoz, 923 F.3d 1023 (Fed. Cir. 2019) (affirming grant of summary judgment), as modified by 776 F. App’x 707 (Fed. Cir. 2019).

Amgen v. Coherus, No. 17-546 (D. Del.)

• Accused Biosimilar: UDENYCA (pegfilgrastim-cbqv)
• Marketing Status: Approved by FDA on November 2, 2018; launched in US on January 3, 2019
• Reference Product: NEULASTA
• Complaint Filed: May 10, 2017
• Litigation Status/Outcome
  • On March 27, 2018, the district court entered a memorandum order granting Coherus’s motion to dismiss for failure to state a claim upon which relief may be granted.
    • Appeal: Amgen v. Coherus, 931 F.3d 1154 (Fed. Cir. 2019) (affirming district court’s dismissal).

Amgen v. Mylan, No. 17-1235 (W.D. Pa.)

• Accused Biosimilar: FULPHILA (pegfilgrastim-jmdb)
• Marketing status: Approved by FDA on June 4, 2018; launched in US at least as of July 26, 2018
• Reference Product: NEULASTA
• Complaint Filed: Sept. 22, 2017
• Litigation Status/Outcome
  • On September 17, 2019, the district court entered a stipulation and order of non-infringement of the ’997 patent.

Amgen v. Accord (previously Apotex), No. 18-61828 (S.D. Fla.)

• Accused Biosimilar: LAPELGA (pegfilgrastim); GRASTOFIL (filgrastim)
• Marketing Status: Not approved; not approved
• Reference Product: NEULASTA; NEUPOGEN
• Complaint Filed: Aug. 7, 2018
• Litigation Status/Outcome
  • On November 15, 2019, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Amgen v. Hospira, No. 20-201 (D. Del.)

• Accused Biosimilar: NYVEPRIA (pegfilgrastim-apgf)
• Marketing Status: Approved by FDA on June 10, 2020; launched in US (launch date unclear)
• Reference Product: NEULASTA
• Complaint Filed: Feb. 11, 2020
• Litigation Status/Outcome
  • On March 21, 2022, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Genentech v. Sandoz, No. 17-13507 (D.N.J.)

• Accused Biosimilar: GP2013 (rituximab)
• Marketing Status: Not approved
• Reference Product: RITUXAN
• Complaint Filed: Dec. 21, 2017
• Litigation Status/Outcome
  • On December 6, 2018, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Genentech v. Celltrion, Nos. 18-574, -11553 (D.N.J.)

• Accused Biosimilar: TRUXIMA (rituximab-abbs)
• Marketing Status: Approved by FDA on November 28, 2018; launched in US on November 11, 2019
• Reference Product: RITUXAN
• Complaint Filed: Jan. 12, 2018
• Litigation Status/Outcome
  • On November 1, 2018, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Genentech v. Pfizer, No. 17-1672 (D. Del.)

• Accused Biosimilar: TRAZIMERA (trastuzumab-qyyp)
• Marketing Status: Approved by FDA on March 11, 2019; launched in US on February 15, 2020
• Reference Product: HERCEPTIN
• Complaint Filed: Nov. 17, 2017
• Litigation Status/Outcome
  • On December 4, 2018, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Genentech v. Celltrion, Nos. 18-095, -1025 (D. Del.)

• Accused Biosimilar: HERZUMA (trastuzumab-pkrb)
• Marketing Status: Approved by FDA on December 14, 2018; launched in US on March 16, 2020
• Reference Product: HERCEPTIN
• Complaint Filed: Jan. 12, 2018
• Litigation Status/Outcome
  • On December 27, 2018, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Genentech v. Amgen, No. 18-924 (D. Del.)

• Accused Biosimilar: KANJINTI (trastuzumab-anns)
• Marketing Status: Approved by FDA of June 13, 2019; launched in US on July 18, 2019
• Reference Product: HERCEPTIN 
• Complaint Filed: June 21, 2018
• Litigation Status/Outcome
  • On July 19, 2019, the district court denied Genentech’s motions for a preliminary injunction and temporary restraining order.
    • Appeal: Genentech v. Amgen, 964 F.3d 1109 (Fed. Cir. 2020) (affirming on interlocutory appeal).
  • On July 7, 2020, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Genentech v. Samsung Bioepis, No. 18-1363 (D. Del.)

• Accused Biosimilar: ONTRUZANT (trastuzumab-dttb)
• Marketing Status: Approved by FDA on January 18, 2019; launched in US on April 15, 2020
• Reference Product: HERCEPTIN
• Complaint Filed: Sept. 4, 2018
• Litigation Status/Outcome
  • On July 1, 2019, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

Genentech v. Tanvex Biopharm, No. 22-CV-0809 (S.D. Cal.)

• Accused Biosimilar: TX05 (trastuzumab)
• Marketing Status: Not approved.
• Reference Product: HERCEPTIN
• Complaint Filed: June 2, 2022
• Litigation Status/Outcome
  • On February 1, 2023, the district court entered a stipulation and order of dismissal after the parties reached a settlement.

• Accused Biosimilar: ABP 654 (ustekinumab)
• Marketing Status: Not approved
• Reference Product: STELARA
• Complaint Filed: Nov. 29, 2022
• Litigation Status/Outcome
  • A joint stipulation of dismissal was filed on May 22, 2023 due to a settlement.