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Articles by Leah Watson
Keytruda Qlex™ Updates: PTAB Finds Four Additional Halozyme PH20 Patents Unpatentable and Halozyme Appeals Prior FWDs
October 14, 2026 To embed, copy and paste the code into your website or blog: On September 25, 2026, the Patent Trial and Appeal Board (“PTAB”) issued Final Written Decisions (“FWD”) in PGR2025-00033 and PGR2025-00039 finding all remaining challenged claims of Halozyme’s U.S. Patent Nos. 12,049,652 (“the ’652 patent”) and 12,104,185 (“the ’185 patent”) unpatentable.
USPTO Director Issues Opinion Explaining Denial of Biocon Post-Grant Review Petition (PGR) Challenging EYLEA® Patent
On September 24, 2026, the USPTO Director issued a decision explaining the denial of institution of PGR2026-00039, filed by Biocon against Regeneron’s U.S. Patent No. 12,168,036 (“the ’036 patent”). BiologicsHQ previously reported that the Director denied institution on August 6, 2026, in a bulk order and noted that an opinion was forthcoming (previously reported Biocon Announces Launch of EYLEA® Interchangeable Biosimilar Yesafili™ While PGR Denied Institution).
Keytruda Qlex™ Updates: PTAB Finds Halozyme '520 PH20 Patent Unpatentable and Institutes Three IPRs | JD Supra
On September 1, 2026, the Patent Trial and Appeal Board ("PTAB") issued a Final Written Decision ("FWD") in PGR2025-00017 finding all remaining challenged claims of Halozyme's U.S. Patent No. 12,110,520 ("the '520 patent") unpatentable. The '520 patent was challenged by Merck and is part of a broader dispute between Merck and Halozyme relating to Keytruda Qlex™ (pembrolizumab; berahyaluronidase alfa-pmph) and Halozyme's PH20 hyaluronidase patent portfolio.
BiologicsHQ Monthly Injection - July 2026 | JD Supra
Welcome to Venable's BiologicsHQ Monthly Injection - July 2026. Please see full publication below for more information.
The FDA Finalizes Guidance on Formal Meetings for Drug and Biologic Development | JD Supra
On August 13, 2026, the FDA (Center for Drug Evaluation and Research ("CDER") and Center for Biologics Evaluation and Research ("CBER")) issued final guidance addressing formal meetings between the FDA and sponsors or applicants relating to the development and review of new drugs and biological products. The guidance finalizes the previous draft from September 2023 and implements agreements from the Prescription Drug User Fee Act (PDUFA) VII negotiations.
Outlook Therapeutics Announces the FDA Approval of LYTENAVA™ for Wet AMD
On July 24, 2026, Outlook Therapeutics announced the FDA approval of Lytenava™ (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (“nAMD”), commonly known as wet AMD. According to Outlook, Lytenava™ is the first ophthalmic formulation of bevacizumab approved by the FDA for the treatment of wet AMD in the United States.
Outlook Therapeutics Announces the FDA Approval of LYTENAVATM for Wet AMD
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PTAB Denies Institution of Additional Elevidys® Gene Therapy IPR | JD Supra
On July 21, 2026, the Director of the U.S. Patent and Trademark Office issued a bulk Order denying institution on the merits of IPR2026-00270, filed by Sarepta Therapeutics, Inc. against Genzyme. The Director found that Sarepta had not demonstrated a reasonable likelihood of prevailing with respect to at least one challenged claim. As with previous bulk Orders by Director Squires, the denial did not provide substantive reasoning.
Congressional Committees Advance Biosimilar Bills Addressing Clinical Study Requirements and Interchangeability | JD Supra
On July 22, 2026, the U.S. Senate Committee on Health, Education, Labor and Pensions ("HELP") voted to advance the Expedited Access to Biosimilars Act ( S. 1414). The Senate action followed the introduction of a House version of the bill ( H. R. 9661) and consideration of the bill by the House Committee on Energy and Commerce earlier in July.
DOJ Files Amicus Brief in Moderna COVID-19 Vaccine Patent Appeal | JD Supra
On June 19, 2026, the U.S. Department of Justice filed an amicus brief on behalf of the United States in Arbutus Biopharma Corp. et al. v. Moderna Inc. et al., No. 26-1581 (Fed. Cir.), supporting Moderna's appeal from the district court's ruling on 28 U.S.C. § 1498(a), which addresses patent infringement claims arising from use or manufacture of patented inventions by or for the United States with government authorization or consent.
Keytruda Qlex™ Updates: PTAB Finds Additional Halozyme PH20 Patent Unpatentable in Final Written Decision
On June 8, 2026, the Patent Trial and Appeal Board (“PTAB”) issued a Final Written Decision (“FWD”) in PGR2025-00004 finding all remaining challenged claims of Halozyme’s U.S. Patent No. 12,018,298 (“the ’298 patent”) unpatentable. The ’298 patent was challenged by Merck and is part of a broader dispute between Merck and Halozyme relating to Keytruda Qlex™ (pembrolizumab; berahyaluronidase alfa-pmph) and Halozyme’s PH20 hyaluronidase patent portfolio.
Senate HELP Committee Advances Bills Addressing FDA / USPTO Disclosures and Biosimilar Interchangeability | JD Supra
On June 17, 2026, the U.S. Senate Committee on Health, Education, Labor and Pensions ("HELP") voted to advance the Medication Affordability and Patent Integrity Act and the Biosimilar Red Tape Elimination Act. The Medication Affordability and Patent Integrity Act would require drug companies to provide certain consistent information to both the FDA and the U.S. Patent and Trademark Office ("USPTO") in connection with FDA approval and patent protection for a small molecule drug or biologic.
Keytruda Qlex™ Updates: Final Written Decisions Find Two Halozyme PH20 Patents Unpatentable While Institution is Denied for Third Patent
On May 12, 2026, the Patent Trial and Appeal Board (“PTAB”) issued a Final Written Decision (“FWD”) in PGR2025-00003 finding all challenged claims of Halozyme’s U.S. Patent No. 11,952,600 (“the ’600 patent”) unpatentable.
PTAB Denies Institution of Two Elevidys® Gene Therapy IPRs
On May 15, 2026, the Director of the U.S. Patent and Trademark Office issued summary institution decisions denying institution on the merits of two additional inter partes review (“IPR”) proceedings, IPR2026-00167 and IPR2026-00168, filed by Sarepta Therapeutics, Inc. against Genzyme relating to patents associated with gene therapy products, including Elevidys® (delandistrogene moxeparvovec-rokl).
PTAB Denies Institution of One Elevidys® IPR and Institutes Another
On May 6, 2026, the Director of the U.S. Patent and Trademark Office issued bulk order institution decisions in two inter partes review (“IPR”) proceedings filed by Sarepta Therapeutics, Inc. against Genzyme relating to patents associated with gene therapy products, including Elevidys® (delandistrogene moxeparvovec-rokl).
FDA Approves Interchangeable Insulin Glargine Biosimilar Langlara™ (insulin glargine-aldy)
On April 29, 2026, the U.S. Food and Drug Administration (FDA) approved Sunshine Lake Pharma’s Langlara™ (insulin glargine-aldy) biosimilar to Sanofi’s Lantus® (insulin glargine), for the treatment of adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes. The FDA granted Langlara™ an interchangeable designation, permitting substitution for Lantus® at the pharmacy level without prescriber intervention, subject to applicable state laws.
FDA Approves Interchangeable Insulin Glargine Biosimilar LanglaraTM (insulin glargine-aldy)
On April 29, 2026, the U.S. Food and Drug Administration (FDA) approved Sunshine Lake Pharma's Langlara™ (insulin glargine-aldy) biosimilar to Sanofi's Lantus® (insulin glargine), for the treatment of adult and pediatric patients with type 1 diabetes...
Federal Circuit Reverses JMOL of Invalidity of Teva’s Ajovy® Patents
On April 16, 2026, the U.S. Court of Appeals for the Federal Circuit reversed the district court’s judgment as a matter of law (“JMOL”) finding Teva’s asserted patent claims invalid for lack of written description and enablement in Teva Pharmaceuticals v. Eli Lilly & Co. (Appeal No. 24-1094) and reinstated the jury’s verdict finding the patents valid and infringed. The case involved Teva’s U.S. Patent Nos.
Biocon Launches Denosumab Biosimilars Bosaya™ / Aukelso™ in the United States
April 21, 2026 To embed, copy and paste the code into your website or blog: On April 7, 2026, Biocon announced the U.S. commercial launch of Bosaya™ / Aukelso™ (denosumab-kyqq), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). Both products were approved by the U.S. Food and Drug Administration in September 2025 and were granted interchangeable designation. Bosaya™ is indicated as a biosimilar to Prolia®, and Aukelso™ as a biosimilar to Xgeva®.
Biocon Launches Denosumab Biosimilars BosayaTM / AukelsoTM in the United States
On April 7, 2026, Biocon announced the U.S. commercial launch of Bosaya™ / Aukelso™ (denosumab-kyqq), biosimilars of Amgen's Prolia® / Xgeva® (denosumab). Both products were approved by the U.S. Food and Drug Administration in September 2025 and were...
FDA and EMA Accept Teva’s Omalizumab Biosimilar Applications
On March 30, 2026, Teva announced that the FDA and the European Medicines Agency (EMA) accepted regulatory submissions for its proposed biosimilar to Xolair® (omalizumab), TEV-45779. The submissions include a Biologics License Application (BLA) to the FDA and a Marketing Authorization Application (MAA) to the EMA.
FDA Approves Teva’s Denosumab Biosimilar Ponlimsi™ (denosumab-adet)
April 15, 2026 To embed, copy and paste the code into your website or blog: On March 30, 2026, the FDA approved Teva’s biosimilar Ponlimsi™ (denosumab-adet), referencing Amgen’s Prolia® (denosumab), for all indications of the reference product. Ponlimsi™ is the tenth Prolia® / Xgeva® (denosumab) biosimilar approved by the FDA.
Biocon Files PGR Petition Challenging Regeneron Eylea® Patent and Seeks Joinder with Alvotech Proceeding
On April 2, 2026, Biocon filed a petition for post-grant review (“PGR”) challenging Regeneron’s U.S. Patent No. 12,168,036 (“the ’036 patent”), which is directed to methods for treating angiogenic eye disorders using high doses of VEGF receptor fusion proteins. The petition, PGR2026-00039, seeks review of claims 1-38 of the ’036 patent and requests joinder with Alvotech’s previously filed PGR2025-00085, which was instituted by the PTAB without an opinion in March 2026.
Amgen Settles BPCIA Litigation Against Henlius Over Prolia® / Xgeva® (denosumab) Biosimilars
April 8, 2026 To embed, copy and paste the code into your website or blog: On March 31, 2026, Amgen reached a settlement with Shanghai Henlius Biotech, resolving BPCIA litigation No. 1:25-cv-12160 (D.N.J.) / 1:25-md-03138 (D.N.J.) concerning Prolia® / Xgeva® (denosumab) biosimilars Bildyos® / Bilprevda® (denosumab-nxxp). This is the eighth Prolia® / Xgeva® biosimilar litigation to settle. The District of New Jersey entered a consent order and judgment resolving the dispute.
Amgen Settles BPCIA Litigation Against Henlius Over Prolia® / Xgeva® (denosumab) Biosimilars
On March 31, 2026, Amgen reached a settlement with Shanghai Henlius Biotech, resolving BPCIA litigation No. 1:25-cv-12160 (D.N.J.) / 1:25-md-03138 (D.N.J.) concerning Prolia® / Xgeva® (denosumab) biosimilars Bildyos® / Bilprevda® (denosumab-nxxp)....
Accord and Bio-Thera File Four IPRs Challenging Janssen Simponi® Patents
March 30, 2026 To embed, copy and paste the code into your website or blog: On March 20, 2026, Accord, Intas, and Bio-Thera Solutions filed four petitions for inter partes review (“IPR”) challenging Janssen patents related to Simponi® (golimumab).
FDA Issues Updated Biosimilar Guidance Removing PK Study Requirement
On March 9, 2026, the FDA updated its guidance addressing biosimilar development under the Biologics Price Competition and Innovation Act (BPCIA) (“New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)”).
Genentech Files ITC Complaint Targeting Biocon’s Proposed Perjeta® (pertuzumab) Biosimilar
March 16, 2026 To embed, copy and paste the code into your website or blog: On February 27, 2026, Genentech filed a complaint under Section 337 of the Tariff Act of 1930 with the U.S. International Trade Commission (ITC) against Biocon concerning its proposed Perjeta® (pertuzumab) biosimilar, BMAB 1500 / PERT-IJS. Genentech seeks a permanent limited exclusion order barring importation and cease-and-desist orders.
Janssen Files First BPCIA Suit Over Simponi® (golimumab) Biosimilar
March 16, 2026 To embed, copy and paste the code into your website or blog: On March 3, 2026, Janssen filed a Complaint in the U.S. District Court for the District of Delaware against Accord and Bio-Thera Solutions, Case No. 1:26-cv-00222 (D. Del.), initiating the first BPCIA litigation related to Janssen / Johnson & Johnson’s Simponi® (golimumab) biosimilar.
Janssen Files First BPCIA Suit Over Simponi® (golimumab) Biosimilar
On March 3, 2026, Janssen filed a Complaint in the U.S. District Court for the District of Delaware against Accord and Bio-Thera Solutions, Case No. 1:26-cv-00222 (D. Del.), initiating the first BPCIA litigation related to Janssen / Johnson &...
FDA Issues Updated Biosimilar Guidance Removing PK Study Requirement
On March 9, 2026, the FDA updated its guidance addressing biosimilar development under the Biologics Price Competition and Innovation Act (BPCIA) ("New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)"). These updates...
BiologicsHQ Monthly Injection - February 2026
March 11, 2026 To embed, copy and paste the code into your website or blog: Welcome to Venable’s BiologicsHQ Monthly Injection - February 2026. Please see full publication below for more information. DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Attorney Advertising.
Sarepta Files Three IPRs Against Genzyme’s Patents Related to Gene Therapy Elevidys® | JD Supra
On December 2, 2025, Sarepta Therapeutics filed three petitions for inter partes review (“IPR”) challenging Genzyme’s patents relating to the characterization of recombinant adeno-associated virus (rAAV) vector preparations.
CAFC Issues Opinions in Enhertu® / Adcetris® Litigation and PGR | JD Supra
On December 2, 2025, the Federal Circuit issued two related decisions concerning Seagen’s U.S. Patent No. 10,808,039 (“the ’039 patent”), asserted against Daiichi Sankyo and AstraZeneca in litigation over the antibody–drug conjugate (ADC) Enhertu® (fam-trastuzumab deruxtecan-nxki). Seagen sells a competing drug, Adcetris® (brentuximab vedotin). In Seagen Inc. v. Daiichi Sankyo Co., Ltd., Nos.
Prolia® / Xgeva® Biosimilar Updates: FDA Approves Accord’s Osvyrti® / Jubereq®, Amgen and Hikma Settle BPCIA Litigation | JD Supra
December 9, 2025 To embed, copy and paste the code into your website or blog: On November 20, 2025, the FDA approved Accord’s Osvyrti® and Jubereq® (denosumab-desu), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab).
ToolGen Files Complaint Against Vertex Concerning Gene Therapy Casgevy® | JD Supra
On November 18, 2025, ToolGen, Inc. (“ToolGen”) filed a complaint (“Complaint”) in the District of Massachusetts alleging infringement of its U.S. Patent No. 12,473,559 (“the ’559 patent”) by Vertex Pharmaceuticals and related entities involved in the development and manufacture of the gene-edited therapy Casgevy® (exagamglogene autotemcel). ToolGen, Inc. v. Vertex Pharmaceuticals Inc., et al., No. 1:25-cv-13441 (D. Mass.).
Sarepta Files Two IPRs Against Genzyme’s Patents Related to Gene Therapy Elevidys® | JD Supra
On November 25, 2025, Sarepta Therapeutics filed two petitions for inter partes review (“IPR”) challenging Genzyme’s patents relating to the characterization of recombinant adeno-associated virus (rAAV) vector preparations. Sarepta filed IPR2026-00149, seeking review of claims 1–5, 7–9, 12–23, and 25–30 of U.S. Patent No. 12,013,326 (“the ’326 patent”), and IPR2026-00150, challenging claims 1–7 and 10–30 of U.S. Patent No. 12,031,894 (“the ’894 patent”).
Sandoz Launches Tyruko® (natalizumab-sztn), First U.S. Biosimilar to Tysabri® | JD Supra
On November 17, 2025, Sandoz and Polpharma announced the U.S. launch of Tyruko® (natalizumab-sztn), the first and only FDA-approved biosimilar to Biogen’s Tysabri® (natalizumab) and the first biosimilar available to treat multiple sclerosis (MS) in the United States. Tyruko® is approved as a monotherapy for all indications covered by reference medicine Tysabri®, including relapsing forms of MS and Crohn’s disease in adults.
FDA Approves first Perjeta® Biosimilar: Shanghai Henlius Biotech / Organon’s Poherdy® | JD Supra
December 2, 2025 To embed, copy and paste the code into your website or blog: On November 13, 2025, the FDA approved Shanghai Henlius Biotech / Organon’s Poherdy® (pertuzumab-dpzb) as the first interchangeable biosimilar of Genentech’s Perjeta® (pertuzumab). Poherdy® is approved for all of the same indications as Perjeta®.
Amgen Files Three New Prolia® / Xgeva® BPCIA Litigations Against Proposed Biosimilars AVT03, MB09, and ENZ215 | JD Supra
On November 6, 2025, Amgen filed its eighth and ninth BPCIA lawsuits against proposed biosimilars of Prolia® / Xgeva® (denosumab), Case No. 1:25-cv-17277 (D.N.J.) against Alvotech and Dr. Reddy’s AVT03 and Case No. 1:25-cv-17278 (D.N.J.) against Amneal, Genhelix, Universal Farma, and mAbxience’s MB09. On November 14, 2025, Amgen filed its tenth BPCIA lawsuit, Case No. 1-25-cv-17596 (D.N.J.) against Alkem Laboratories, Ascend Laboratories, and Enzene Biosciences’s proposed biosimilar ENZ215.
PTAB Denies Institution of Two Sarepta IPRs Related to Elevidys® | JD Supra
On November 6, 2025, the Patent Trial and Appeal Board (“Board”) issued decisions denying institution of Sarepta Therapeutics’ IPR2025-01194 against claims 3-6 of Genzyme’s U.S. Patent No. 9,051,542 (“the ’542 patent) and IPR2025-01195 against claims 1-4, 6-7 and 11 of U.S. Patent No. 7,704,721 (“the ’721 patent”). The denials were issued as Director summary notices with no reasoning provided.
Hikma Announces Launch of Stelara® (ustekinumab) Biosimilar Starjemza™ | JD Supra
November 17, 2025 To embed, copy and paste the code into your website or blog: On November 6, 2025, Hikma announced the U.S. launch of Starjemza™ (ustekinumab-hmny), a biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab). Starjemza™ is approved for all the reference product’s indications, including certain patients with plaque psoriasis, active psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs in New Draft Guidance | JD Supra
On October 29, 2025, the FDA released a new draft guidance “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies” designed to accelerate the development of biosimilars and reduce drug costs by simplifying the testing process and removing unnecessary clinical study requirements.
Regeneron Settles Litigations with Celltrion over EYLEA® Biosimilar Eydenzelt® | JD Supra
October 29, 2025 To embed, copy and paste the code into your website or blog: On October 20, 2025, Celltrion and Regeneron announced they reached a settlement agreement, dismissing Case Nos. 1-23-cv-00089 (N.D.W. Va.) and 1-24-cv-00053 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) and allowing the commercialization of EYLEA® (aflibercept) biosimilar Eydenzelt® (aflibercept-boav) as of December 31, 2026.
PTAB Grants Institution of Four PGRs related to Merck’s Keytruda Qlex™ | JD Supra
Beginning in November 2024, Merck Sharp & Dohme, LLC (“Merck”) requested post-grant review (“PGR”) of 14 patents owned by Halozyme, Inc. (“Halozyme”), with claims directed to modified PH20 hyaluronidase polypeptides, including modified polypeptides that exhibit increased stability and/or increased activity. On October 10, 2025, the PTAB instituted PGR2025-00046 against Halozyme’s U.S. Patent No. 12,091,692 (“the ’692 patent”).
PTAB Grants Amgen’s Request for Adverse Judgment Prior to Institution of Trial in Opdivo® IPR2025-00603 | JD Supra
On October 1, 2025, the PTAB granted Amgen’s request for adverse judgment based on Bristol-Myers Squibb’s (“BMS”) statutory disclaimer of all challenged claims prior to institution of trial. Amgen’s IPR2025-00603 challenged all the claims of BMS’s U.S. Patent No. 11,332,529 (“the ’529 patent”), related to BMS’s Opdivo® (nivolumab) and Yervoy® (ipilimumab). Amgen is currently developing a biosimilar of Opdivo®, referred to as ABP 206.
Celltrion launches Actemra® Biosimilar Avtozma® | JD Supra
October 27, 2025 To embed, copy and paste the code into your website or blog: On October 2, 2025, Celltrion launched Avtozma® (tocilizumab-anoh), in intravenous and subcutaneous formulations, as the third biosimilar of Genentech’s Actemra® (tocilizumab). Avtozma® was approved by the FDA on January 24, 2025 (previously reported FDA Approves Third Actemra® Biosimilar, Celltrion’s Avtozma® (tocilizumab-anoh)).
Pembrolizumab Patent IPR Final Written Decisions Issued Finding Claims Unpatentable | JD Supra
On September 18, 2025, the Patent Trial and Appeal Board (“Board”) issued a Final Written Decision (“FWD”) in Merck’s IPR2024-00625 against The Johns Hopkins University’s (“JHU”) U.S. Patent No. 11,339,219 B2 (“the ’219 patent”), finding claims 1–8 of the ’219 patent unpatentable. Merck sells anti-PD-1 antibody Keytruda® (pembrolizumab), which is FDA-approved for patients with microsatellite instability-high (“MSI-H”) and dMMR colorectal cancer.
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