Is this you? As a journalist, you can create a free Muck Rack account to customize your profile, list your contact preferences, and upload a portfolio of your best work.
Claim your profile
Articles by Christopher Cassella
Update: Janssen Files BPCIA Complaint Against Bio-Thera And Accord Related To Golimumab Biosimilar
Natasha E. Daughtrey’s articles from Goodwin Procter LLP are most popular: with readers working within the Aerospace & Defence, Banking & Credit and Healthcare industries Goodwin Procter LLP are most popular: within Cannabis & Hemp, Criminal Law and Immigration topic(s) As we reported last week, Janssen Biotech, Inc. and Janssen Sciences Ireland UC (collectively, “Janssen”) filed under seal a BPCIA complaint in the U.S. District Court for the District of Delaware against Accord BioPharma, Inc.
Update: Janssen Files BPCIA Complaint Against Bio-Thera and Accord Related to Golimumab Biosimilar
As we previously reported, Janssen Biotech, Inc. and Janssen Sciences Ireland UC (collectively, “Janssen”) filed under seal a BPCIA complaint in the U.S. District Court for the District of Delaware against Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd. (collectively, “Defendants”), alleging that Accord and Bio-Thera infringe 17 patents in relation to their proposed golimumab biosimilar.
Update: Janssen Files BPCIA Complaint Against Bio-Thera and Accord Related to Golimumab Biosimilar
As we reported last week, Janssen Biotech, Inc. and Janssen Sciences Ireland UC (collectively, “Janssen”) filed under seal a BPCIA complaint in the U.S. District Court for the District of Delaware against Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd. (collectively, “Defendants”), alleging that Accord and Bio-Thera infringe 17 patents in relation to their proposed golimumab biosimilar. A redacted version of that complaint has now been filed, revealing some additional details about the lawsuit.
Update: Janssen Files BPCIA Complaint Against Bio-Thera and Accord Related to Golimumab Biosimilar
As we reported last week, Janssen Biotech, Inc. and Janssen Sciences Ireland UC (collectively, “Janssen”) filed under seal a BPCIA complaint in the U.S. District Court for the District of Delaware against Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd. (collectively, “Defendants”), alleging that Accord and Bio-Thera infringe 17 patents in relation to their proposed golimumab biosimilar. A redacted version of that complaint has now been filed, revealing some additional details about the lawsuit.
Janssen Files BPCIA Complaint Against Bio-Thera And Accord Related To Golimumab Biosimilar
Christopher Cassella’s articles from Goodwin Procter LLP are most popular: with readers working within the Banking & Credit, Healthcare and Pharmaceuticals & BioTech industries Goodwin Procter LLP are most popular: within Criminal Law, Immigration and Cannabis & Hemp topic(s) On March 3, Janssen Biotech, Inc. and Janssen Sciences Ireland UC (collectively, "Janssen") filed a BPCIA complaint in the U.S. District Court for the District of Delaware against Accord BioPharma, Inc.
Genentech Brings Pertuzumab Biosimilar Fight To The ITC
Natasha E. Daughtrey’s articles from Goodwin Procter LLP are most popular: within Food, Drugs, Healthcare and Life Sciences topic(s) in United States Goodwin Procter LLP are most popular: within Criminal Law, Immigration and Cannabis & Hemp topic(s) On February 27, 2026, Genentech filed a Section 337 complaint at the U.S. International Trade Commission (ITC) targeting Biocon's proposed pertuzumab biosimilar, BMAB 1500/PERT-IJS, which references Genentech's PERJETA®.
Federal Circuit Finds Claims Directed to Host Cells Patent-Eligible
On February 20, 2026, the Federal Circuit held that patent claims directed to a cultured host cell are patent-eligible under 35 U.S.C. § 101—reversing a district court’s January 2024 decision granting summary judgment of patent ineligibility. The Federal Circuit decision makes clear that recombinant, human‑engineered host cells are patent‑eligible, even if their constituent sequences have natural origins.
Federal Circuit Finds Claims Directed to Host Cells Patent-Eligible
On February 20, 2026, the Federal Circuit held that patent claims directed to a cultured host cell are patent-eligible under 35 U.S.C. § 101—reversing a district court’s January 2024 decision granting summary judgment of patent ineligibility. The Federal Circuit decision makes clear that recombinant, human‑engineered host cells are patent‑eligible, even if their constituent sequences have natural origins.
Federal Circuit Finds Claims Directed to Host Cells Patent-Eligible
On February 20, 2026, the Federal Circuit held that patent claims directed to a cultured host cell are patent-eligible under 35 U.S.C. § 101—reversing a district court’s January 2024 decision granting summary judgment of patent ineligibility. The Federal Circuit decision makes clear that recombinant, human‑engineered host cells are patent‑eligible, even if their constituent sequences have natural origins.
Janssen Files BPCIA Complaint Against Bio-Thera and Accord Related to Golimumab Biosimilar | JD Supra
On March 3, Janssen Biotech, Inc. and Janssen Sciences Ireland UC (collectively, “Janssen”) filed a BPCIA complaint in the U.S. District Court for the District of Delaware against Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd., alleging that Accord and Bio-Thera infringe 17 patents in relation to their proposed golimumab biosimilar. Janssen’s complaint was filed under seal, with a redacted version due to be filed on March 11.
Janssen Files BPCIA Complaint Against Bio-Thera and Accord Related to Golimumab Biosimilar
On March 3, Janssen Biotech, Inc. and Janssen Sciences Ireland UC (collectively, “Janssen”) filed a BPCIA complaint in the U.S. District Court for the District of Delaware against Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd., alleging that Accord and Bio-Thera infringe 17 patents in relation to their proposed golimumab biosimilar. Janssen’s complaint was filed under seal, with a redacted version due to be filed on March 11.
Janssen Files BPCIA Complaint Against Bio-Thera and Accord Related to Golimumab Biosimilar
On March 3, Janssen Biotech, Inc. and Janssen Sciences Ireland UC (collectively, “Janssen”) filed a BPCIA complaint in the U.S. District Court for the District of Delaware against Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd., alleging that Accord and Bio-Thera infringe 17 patents in relation to their proposed golimumab biosimilar. Janssen’s complaint was filed under seal, with a redacted version due to be filed on March 11.
Genentech Brings Pertuzumab Biosimilar Fight to the ITC | JD Supra
On February 27, 2026, Genentech filed a Section 337 complaint at the U.S. International Trade Commission (ITC) targeting Biocon’s proposed pertuzumab biosimilar, BMAB 1500/PERT-IJS, which references Genentech’s PERJETA®. The complaint, captioned Certain Pertuzumab Biosimilars, Including Those Made by Certain Methods of Manufacturing, the Active Ingredient Thereof, and Products Containing the Same, seeks a permanent limited exclusion order and cease-and-desist orders.
Genentech Brings Pertuzumab Biosimilar Fight to the ITC
On February 27, 2026, Genentech filed a Section 337 complaint at the U.S. International Trade Commission (ITC) targeting Biocon’s proposed pertuzumab biosimilar, BMAB 1500/PERT-IJS, which references Genentech’s PERJETA®. The complaint, captioned Certain Pertuzumab Biosimilars, Including Those Made by Certain Methods of Manufacturing, the Active Ingredient Thereof, and Products Containing the Same, seeks a permanent limited exclusion order and cease-and-desist orders.
Genentech Brings Pertuzumab Biosimilar Fight to the ITC
On February 27, 2026, Genentech filed a Section 337 complaint at the U.S. International Trade Commission (ITC) targeting Biocon’s proposed pertuzumab biosimilar, BMAB 1500/PERT-IJS, which references Genentech’s PERJETA®. The complaint, captioned Certain Pertuzumab Biosimilars, Including Those Made by Certain Methods of Manufacturing, the Active Ingredient Thereof, and Products Containing the Same, seeks a permanent limited exclusion order and cease-and-desist orders.
Hikma Launches Denosumab Biosimilars ENOBY And XTRENBO
Christopher Cassella’s articles from Goodwin Procter LLP are most popular: within Food, Drugs, Healthcare and Life Sciences topic(s) with readers working within the Healthcare and Construction & Engineering industries Goodwin Procter LLP are most popular: within Criminal Law, Immigration and Cannabis & Hemp topic(s) On January 19, 2026, Hikma announced the U.S. launch of ENOBY (denosumab-qbde) and XTRENBO (denosumab-qbde)—denosumab biosimilars referencing Amgen's PROLIA and XGEVA, respectively.
Genentech/Hoffmann La-Roche And Shanghai Henlius Biotech/Organon Settle Pertuzumab BPCIA Case
Goodwin Procter LLP are most popular: within Immigration, Criminal Law and Cannabis & Hemp topic(s) On January 30, 2026, the U.S. District Court for the District of New Jersey entered a Joint Stipulation of Dismissal resolving the pertuzumab BPCIA litigation between Genentech, Inc. and Hoffmann-La Roche Inc.
Hikma Launches Denosumab Biosimilars ENOBY and XTRENBO
On January 19, 2026, Hikma announced the U.S. launch of ENOBY (denosumab-qbde) and XTRENBO (denosumab-qbde)—denosumab biosimilars referencing Amgen’s PROLIA and XGEVA, respectively.
Hikma Launches Denosumab Biosimilars ENOBY and XTRENBO
On January 19, 2026, Hikma announced the U.S. launch of ENOBY (denosumab-qbde) and XTRENBO (denosumab-qbde)—denosumab biosimilars referencing Amgen’s PROLIA and XGEVA, respectively.
Genentech/Hoffmann La-Roche and Shanghai Henlius Biotech/Organon Settle Pertuzumab BPCIA Case
On January 30, 2026, the U.S. District Court for the District of New Jersey entered a Joint Stipulation of Dismissal resolving the pertuzumab BPCIA litigation between Genentech, Inc. and Hoffmann-La Roche Inc. (together, “Genentech”) and Shanghai Henlius Biotech, Inc., Shanghai Henlius Biologics Co., Ltd., Organon LLC, and Organon & Co. after the parties entered into a confidential settlement agreement.
Genentech/Hoffmann La-Roche and Shanghai Henlius Biotech/Organon Settle Pertuzumab BPCIA Case
On January 30, 2026, the U.S. District Court for the District of New Jersey entered a Joint Stipulation of Dismissal resolving the pertuzumab BPCIA litigation between Genentech, Inc. and Hoffmann-La Roche Inc. (together, “Genentech”) and Shanghai Henlius Biotech, Inc., Shanghai Henlius Biologics Co., Ltd., Organon LLC, and Organon & Co. after the parties entered into a confidential settlement agreement.
FDA Approves Accord BioPharma's Denosumab Biosimilars
Goodwin Procter LLP are most popular: within Transport topic(s) On November 20, 2025, the FDA approved Accord BioPharma's denosumab biosimilars OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu), which reference Amgen's PROLIA® and XGEVA®, respectively. This marks the eighth set of denosumab biosimilars approved by the FDA. Both OSVYRTI® and JUBEREQ® are approved for all indications of their respective reference products.
Sandoz Launches Natalizumab Biosimilar
Goodwin Procter LLP are most popular: within Transport topic(s) On November 17, 2025, Sandoz announced the launch of TYRUKO® (natalizumab-sztn) in the United States as the first and only biosimilar for the treatment of relapsing forms of multiple sclerosis. TYRUKO® was approved by FDA in August 2023 to treat all indications covered by Biogen's TYSABRI®, including relapsing forms of MS and Crohn's disease in adults.
Sandoz Launches Natalizumab Biosimilar | JD Supra
On November 17, 2025, Sandoz announced the launch of TYRUKO® (natalizumab-sztn) in the United States as the first and only biosimilar for the treatment of relapsing forms of multiple sclerosis. TYRUKO® was approved by FDA in August 2023 to treat all indications covered by Biogen’s TYSABRI®, including relapsing forms of MS and Crohn’s disease in adults.
Sandoz Launches Natalizumab Biosimilar
On November 17, 2025, Sandoz announced the launch of TYRUKO® (natalizumab-sztn) in the United States as the first and only biosimilar for the treatment of relapsing forms of multiple sclerosis. TYRUKO® was approved by FDA in August 2023 to treat all indications covered by Biogen’s TYSABRI®, including relapsing forms of MS and Crohn’s disease in adults.
FDA Approves Accord BioPharma’s Denosumab Biosimilars | JD Supra
On November 20, 2025, the FDA approved Accord BioPharma’s denosumab biosimilars OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu), which reference Amgen’s PROLIA® and XGEVA®, respectively. This marks the eighth set of denosumab biosimilars approved by the FDA. Both OSVYRTI® and JUBEREQ® are approved for all indications of their respective reference products. Denosumab is a human IgG2 monoclonal antibody that inhibits osteoclast activation, preventing the breakdown of bone.
FDA Approves Accord BioPharma’s Denosumab Biosimilars
On November 20, 2025, the FDA approved Accord BioPharma’s denosumab biosimilars OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu), which reference Amgen’s PROLIA® and XGEVA®, respectively. This marks the eighth set of denosumab biosimilars approved by the FDA. Both OSVYRTI® and JUBEREQ® are approved for all indications of their respective reference products. Denosumab is a human IgG2 monoclonal antibody that inhibits osteoclast activation, preventing the breakdown of bone.
FDA Approves Accord BioPharma’s Denosumab Biosimilars
On November 20, 2025, the FDA approved Accord BioPharma’s denosumab biosimilars OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu), which reference Amgen’s PROLIA® and XGEVA®, respectively. This marks the eighth set of denosumab biosimilars approved by the FDA. Both OSVYRTI® and JUBEREQ® are approved for all indications of their respective reference products. Denosumab is a human IgG2 monoclonal antibody that inhibits osteoclast activation, preventing the breakdown of bone.
FDA Grants Interchangeability Designation To Fresenius Kabi's And Celltrion's Denosumab Biosimilars
Goodwin Procter LLP are most popular: within Transport topic(s) This week the FDA granted interchangeability status to Fresenius Kabi's and Celltrion's respective denosumab biosimilars. Interchangeable biosimilars can be substituted for the reference product at the pharmacy without intervention of the prescribing healthcare provider.
FDA Grants Interchangeability Designation to Fresenius Kabi’s and Celltrion’s Denosumab Biosimilars | JD Supra
This week the FDA granted interchangeability status to Fresenius Kabi’s and Celltrion’s respective denosumab biosimilars. Interchangeable biosimilars can be substituted for the reference product at the pharmacy without intervention of the prescribing healthcare provider.
FDA Grants Interchangeability Designation to Fresenius Kabi’s and Celltrion’s Denosumab Biosimilars
This week the FDA granted interchangeability status to Fresenius Kabi’s and Celltrion’s respective denosumab biosimilars. Interchangeable biosimilars can be substituted for the reference product at the pharmacy without intervention of the prescribing healthcare provider.
Amgen And Biocon Settle Denosumab BPCIA Case
On September 30, 2025, the U.S. District Court for the District of New Jersey entered a Consent Judgment and Injunction resolving the denosumab BPCIA litigation between Amgen, Inc. ("Amgen") and Biocon Biologics, Inc., Biocon Biologics UK Limited, Biocon Biologics Limited, and Biosimilars Newco Limited (collectively, "Biocon") after Amgen and Biocon executed a Confidential Settlement Agreement.
Amgen and Biocon Settle Denosumab BPCIA Case
On September 30, 2025, the U.S. District Court for the District of New Jersey entered a Consent Judgment and Injunction resolving the denosumab BPCIA litigation between Amgen, Inc. (“Amgen”) and Biocon Biologics, Inc., Biocon Biologics UK Limited, Biocon Biologics Limited, and Biosimilars Newco Limited (collectively, “Biocon”) after Amgen and Biocon executed a Confidential Settlement Agreement.
Sandoz Launches PYZCHIVA® (Ustekinumab) Autoinjector In Europe
On May 21, 2025, Sandoz announced the commerciallaunchin Europe of its PYZCHIVA® (ustekinumab) autoinjector, "the first ustekinumab biosimilar in Europe commercially available in an autoinjector." PYZCHIVA® — a biosimilar of Janssen's STELARA® — is approved for the treatment of adults with plaque psoriasis, psoriatic arthritis, Crohn's disease and pediatric plaque psoriasis for patients six years and older weighing over 60 kg.
Sandoz Launches PYZCHIVA® (Ustekinumab) Autoinjector in Europe | JD Supra
On May 21, 2025, Sandoz announced the commercial launch in Europe of its PYZCHIVA® (ustekinumab) autoinjector, “the first ustekinumab biosimilar in Europe commercially available in an autoinjector.” PYZCHIVA®—a biosimilar of Janssen’s STELARA®—is approved for the treatment of adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease and pediatric plaque psoriasis for patients six years and older weighing over 60 kg.
Sandoz Launches PYZCHIVA® (Ustekinumab) Autoinjector in Europe
On May 21, 2025, Sandoz announced the commercial launch in Europe of its PYZCHIVA® (ustekinumab) autoinjector, “the first ustekinumab biosimilar in Europe commercially available in an autoinjector.” PYZCHIVA®—a biosimilar of Janssen’s STELARA®—is approved for the treatment of adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease and pediatric plaque psoriasis for patients six years and older weighing over 60 kg.
Del. Judge Connolly Says Preambles Are Limiting, Cites Alice In Wonderland, And Invites The Federal Circuit To Weigh In
Back in May 2023, Alnylam brought suit against Pfizer and BioNTech in the District of Delaware, alleging infringement of patents directed to vaccine lipid nanoparticle technology. On August 12, 2024, Chief Judge Connolly issued a memorandum opinion construing the claim term "vaccine" in one of the asserted patents (U.S. Patent No. 11,590,229). The parties' dispute did not concern the meaning of "vaccine"; rather, the parties disputed whether the term was limiting, i.e., an element of the claims.
Del. Judge Connolly Says Preambles Are Limiting, Cites Alice in Wonderland, and Invites the Federal Circuit to Weigh In | JD Supra
Back in May 2023, Alnylam brought suit against Pfizer and BioNTech in the District of Delaware, alleging infringement of patents directed to vaccine lipid nanoparticle technology. On August 12, 2024, Chief Judge Connolly issued a memorandum opinion construing the claim term “vaccine” in one of the asserted patents (U.S. Patent No. 11,590,229). The parties’ dispute did not concern the meaning of “vaccine”; rather, the parties disputed whether the term was limiting, i.e., an element of the claims.
Del. Judge Connolly Says Preambles Are Limiting, Cites Alice in Wonderland, and Invites the Federal Circuit to Weigh In
Back in May 2023, Alnylam brought suit against Pfizer and BioNTech in the District of Delaware, alleging infringement of patents directed to vaccine lipid nanoparticle technology. On August 12, 2024, Chief Judge Connolly issued a memorandum opinion construing the claim term “vaccine” in one of the asserted patents (U.S. Patent No. 11,590,229). The parties’ dispute did not concern the meaning of “vaccine”; rather, the parties disputed whether the term was limiting, i.e., an element of the claims.
Genzyme Sues Sarepta for Infringement of Gene Therapy Patents | JD Supra
On July 26, 2024, Genzyme Corp. (a wholly owned subsidiary of Sanofi) filed suit in the District Court for the District of Delaware against Sarepta Therapeutics, Inc., and Sarepta Therapeutics Three, LLC (collectively, “Sarepta”). Genzyme alleges that Sarepta’s manufacture and sale of Elevidys® (delandistrogene moxeparvovec-rokl)—a gene therapy treatment for Duchenne muscular dystrophy—infringes U.S. Patent Nos. 9,051,542 and 7,704,721.
Genzyme Sues Sarepta For Infringement Of Gene Therapy Patents
On July 26, 2024, Genzyme Corp. (a wholly owned subsidiary of Sanofi) filed suit in the District Court for the District of Delaware against Sarepta Therapeutics, Inc., and Sarepta Therapeutics Three, LLC (collectively, "Sarepta"). Genzyme alleges that Sarepta's manufacture and sale of Elevidys® (delandistrogene moxeparvovec-rokl)—a gene therapy treatment for Duchenne muscular dystrophy—infringes U.S. Patent Nos. 9,051,542 and 7,704,721.
Genzyme Sues Sarepta for Infringement of Gene Therapy Patents
On July 26, 2024, Genzyme Corp. (a wholly owned subsidiary of Sanofi) filed suit in the District Court for the District of Delaware against Sarepta Therapeutics, Inc., and Sarepta Therapeutics Three, LLC (collectively, “Sarepta”). Genzyme alleges that Sarepta’s manufacture and sale of Elevidys® (delandistrogene moxeparvovec-rokl)—a gene therapy treatment for Duchenne muscular dystrophy—infringes U.S. Patent Nos. 9,051,542 and 7,704,721.
Genentech And Partners Voluntarily Dismiss IPR Appeals Related To Genentech's ACTEMRA® (Tocilizumab)
On February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche filed a motion for voluntary dismissal of their appeals of the PTAB's Final Written Decisions in IPR2022-00578 and IPR2022-00579. The appeals concerned IPRs filed by Celltrion where the PTAB found all challenged claims of U.S. Patent Nos. 8,580,264 and 10,874,677 were either anticipated by or obvious over the prior art. The '264 and '677 patents are directed to methods of treatment and drug delivery using tocilizumab. Genentech et al.
Genentech and Partners Voluntarily Dismiss IPR Appeals Related to Genentech’s ACTEMRA® (Tocilizumab) | JD Supra
On February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche filed a motion for voluntary dismissal of their appeals of the PTAB’s Final Written Decisions in IPR2022-00578 and IPR2022-00579. The appeals concerned IPRs filed by Celltrion where the PTAB found all challenged claims of U.S. Patent Nos. 8,580,264 and 10,874,677 were either anticipated by or obvious over the prior art. The ‘264 and ‘677 patents are directed to methods of treatment and drug delivery using tocilizumab. Genentech et al.
Genentech and Partners Voluntarily Dismiss IPR Appeals Related to Genentech’s ACTEMRA® (Tocilizumab)
On February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche filed a motion for voluntary dismissal of their appeals of the PTAB’s Final Written Decisions in IPR2022-00578 and IPR2022-00579. The appeals concerned IPRs filed by Celltrion where the PTAB found all challenged claims of U.S. Patent Nos. 8,580,264 and 10,874,677 were either anticipated by or obvious over the prior art. The ‘264 and ‘677 patents are directed to methods of treatment and drug delivery using tocilizumab. Genentech et al.
Genentech and Partners Voluntarily Dismiss IPR Appeals Related to Genentech’s ACTEMRA® (Tocilizumab)
On February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche filed a motion for voluntary dismissal of their appeals of the PTAB’s Final Written Decisions in IPR2022-00578 and IPR2022-00579. The appeals concerned IPRs filed by Celltrion where the PTAB found all challenged claims of U.S. Patent Nos. 8,580,264 and 10,874,677 were either anticipated by or obvious over the prior art. The ‘264 and ‘677 patents are directed to methods of treatment and drug delivery using tocilizumab. Genentech et al.
Update On Ophthalmic Anti-VEGF Therapeutics
Below we provide an update on several ophthalmic anti-VEGF therapeutics currently being studied in clinical trials. EYLEA® HD (Aflibercept, 8 mg) Regeneron positive two-year (96 weeks) results from its PULSAR trial investigating Eylea® HD (aflibercept, 8 mg) with 12- and 16-week dosing regimens compared to EYLEA® (aflibercept, 2 mg) in patients with wet AMD. One of the trial investigators, Charles C.
Show More
loading
Actions
Is this you?
As a journalist, you can create a free Muck Rack account to customize your profile, list your contact preferences, and upload a portfolio of your best work.Get in touch with Christopher
Contact Christopher, search articles and posts on X, monitor coverage, and track replies from one place.
Learn more about Muck Rack