According to the FDA, “[t]he safety and effectiveness of Kresladi were established in one open-label, single-arm, multicenter study based on [indicators of improved immune activity] at month 12 with sustained effect through month 24 post-infusion.”  The application for Kresladi was granted multiple special designations including Orphan Drug, Rare Pediatric Disease, Regenerative Medicine Advanced Therapy and Fast Track designations.  As a condition of Kresladi’s approval, Rocket Pharmaceuticals, Inc. will conduct post-approval studies to verify and describe the clinical benefits.  Per the FDA, “[c]ontinued approval may be contingent upon verification of clinical benefit in confirmatory trials.”

The post FDA Approves First Gene Therapy for Rare Pediatric Immune Disorder Severe Leukocyte Adhesion Deficiency Type I appeared first on Big Molecule Watch.

Approval for the new EYLEA HD dosing regimen comes nearly one year after the FDA’s complete response letter to Regeneron’s request for an extension in dosing schedule up to every 24 weeks.  According to Regeneron, the “[n]ew EYLEA HD dosing regimen allows patients with wAMD and DME to be treated as infrequently as 2 to 3 times a year, further extending the widest range of dosing intervals of any approved injectable anti-VEGF [treatment].”

The post FDA Approves Extended Dosing Interval for Regeneron’s EYLEA HD (aflibercept) appeared first on Big Molecule Watch.

Additionally, Teva announced that its applications for a proposed biosimilar to XOLAIR® (omalizumab) have been accepted by both the FDA and the EMA.  The applications include all indications approved for the reference product, Genentech and Novartis’s XOLAIR®, including the treatment of moderate-to-severe (U.S.)/severe (EU) persistent allergic asthma (ages 6+), chronic rhinosinusitis with nasal polyps (adults 18+), chronic spontaneous urticaria (ages 12+) and, in the U.S., IgE-mediated food allergies (ages 1+).

Stay tuned to Big Molecule Watch as we continue to monitor updates in the biosimilars industry.

The post Teva Receives FDA Approval of Denosumab Biosimilar and Filing Acceptances by FDA and EMA For Omalizumab Biosimilar appeared first on Big Molecule Watch.

This settlement follows Amgen’s settlement of denosumab litigations with Celltrion, Sandoz, Fresenius, Accord, Samsung Bioepis, Biocon, and Hikma/Gedeon.  Amgen’s denosumab BPCIA litigations against Alkem, Dr. Reddy’s/Alvotech, and Amneal remain pending.

Denosumab is a human IgG2 monoclonal antibody that inhibits osteoclast activation, preventing the breakdown of bone.  First marketed by Amgen as PROLIA® and XGEVA®, denosumab is used to treat conditions associated with bone loss, such as osteoporosis, and to treat bone cancers and prevent fractures in patients with bone metastases.

There are currently four pairs of denosumab biosimilars on the market, with Sandoz, Celltrion, Fresenius, and Hikma/Gedeon launching their respective products in 2025 and 2026.  The Consent Order did not identify when Henlius and Organon will be allowed to launch their denosumab biosimilars.

The post Amgen and Shanghai Henlius/Organon Settle Denosumab BPCIA Litigation appeared first on Big Molecule Watch.

As we reported last month, Formycon is partnering with Lotus Pharmaceutical to commercialize AHZANTIVE in the Asia-Pacific Region.  Formycon previously settled its U.S. aflibercept litigation with Regeneron, securing Formycon a Q4 2026 launch date of AHZANTIVE in the United States.

The post Formycon and Regeneron Settle European Aflibercept Biosimilar Litigation appeared first on Big Molecule Watch.

Two of the IPRs, IPR2026-00256 and IPR2026-00259, challenge U.S. Patent No. 11,014,982 (the “’982 patent”) and U.S. Patent No. 12,291,566 (the “’566 patent”), respectively. Both patents are directed toward methods of treating active ankylosing spondylitis (“AS”).  Petitioners argue that all 10 claims of the ’982 patent and all 7 claims of the ’566 patent are anticipated by Janssen’s clinical trial protocol NCT02186873-V24, which Petitioners assert was publicly available on ClinicalTrials.gov on October 27, 2015, or obvious over a combination of NCT02186873-V24, the labels for SIMPONI® (2015) and SIMPONI ARIA® (2013), and two publications from 2008 and 2014 describing the results of Janssen’s Phase III clinical trials investigating the use of golimumab to treat AS.

The other two IPRs, IPR2026-00257 and IPR2026-00258, challenge U.S. Patent No. 11,041,020 (the “’020 patent”) and U.S. Patent No. 12,122,824 (the “’824 patent”), respectively. Both patents are directed toward methods of treating psoriatic arthritis (“PsA”). Petitioners argue that all 10 claims of the ’020 patent and all 7 claims of the ’824 patent are anticipated by Janssen’s clinical trial protocol NCT02181673-V23, which Petitioners assert was publicly available on ClinicalTrials.gov on January 8, 2016, or obvious over a combination of NCT02181673-V23, the labels for SIMPONI® (2015) and SIMPONI ARIA® (2013), a set of reports from Janssen’s Phase III clinical trial of the use of golimumab for the treatment of PsA, and an Abbott Biotechnology Ltd. international patent publication.

All four challenged patents had issued within the last five years. Once the IPRs are accorded a notice of filing date, Janssen will have two months to submit discretionary denial briefs and three months to file preliminary responses.

On March 3, 2026, Janssen and Janssen Sciences Ireland UC filed a BPCIA complaint against Bio-Thera and Accord.  The case is pending in the U.S. District Court for the District of Delaware.

Stay tuned to Big Molecule Watch for further updates on these IPRs and the associated BPCIA litigation!

The post Accord, Intas, and Bio-Thera File Four IPRs Against Janssen Golimumab Patents appeared first on Big Molecule Watch.

Golimumab is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF-α), a cytokine involved in inflammatory processes. By binding to TNF-α, golimumab reduces levels of several inflammatory markers, including C-reactive protein (CRP), interleukin-6 (IL-6), intercellular adhesion molecule 1 (ICAM-1), matrix metalloproteinase-3 (MMP-3), and vascular endothelial growth factor (VEGF).  SIMPONI® has been approved in multiple jurisdictions for the treatment of conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.

The post Bio-Thera and Intas Expand Golimumab Biosimilar Partnership to India appeared first on Big Molecule Watch.

On March 16, 2026, Celltrion, Inc. announced the U.S. commercial launch of AVTOZMA® (tocilizumab-anoh) SC, a subcutaneous formulation of its tocilizumab biosimilar referencing Roche’s ACTEMRA. Celltrion had previously launched its intravenous AVTOZMA® in October 2025. With this new launch, AVTOZMA® becomes one of the first tocilizumab biosimilars to have both an intravenous (IV) and subcutaneous (SC) formulation approved by the FDA and commercially available in the United States.

In January 2025, the FDA approved AVTOZMA® for subcutaneous and intravenous use based on data from a global Phase III clinical trial evaluating the biosimilar’s efficacy, pharmacokinetics, safety, and immunogenicity against reference tocilizumab. In July 2025, the FDA further approved the IV formulation for an additional indication covering cytokine release syndrome (CRS) in adult and pediatric patients aged two years and older.

The SC formulation of AVTOZMA® is indicated for the treatment of rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (PJIA), and systemic juvenile idiopathic arthritis (SJIA). It is available as a 162 mg/0.9 mL solution for injection in a single-dose prefilled syringe or autoinjector, enabling patients to self-administer the treatment at home.

The post Celltrion Announces AVTOZMA (tocilizumab-anoh) Now Available in U.S. appeared first on Big Molecule Watch.

As part of the agreement, Sandoz and Samsung Bioepis will first collaborate on a vedolizumab biosimilar to Takeda’s ENTYVIO.  In the United States, ENTYVIO is indicated for the treatment of moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease in certain adults.  In the European Union, ENTYVIO is also indicated for the treatment of moderately to severely active chronic pouchitis in certain adults.  The vedolizumab biosimilar is currently in early-stage development.

This agreement follows a 2023 collaboration between the two companies concerning PYZCHIVA (ustekinumab) and a 2025 collaboration to commercialize EPYSQLI (eculizumab) in the Middle East and Africa. 

The agreement with Sandoz is not the only collaboration agreement announced by Samsung Bioepis this month.  On March 15, Samsung Bioepis and Epis NexLab Co., Ltd. (both subsidiaries of the recently formed Samsung Epis Holdings) announced a research collaboration and license agreement with G2GBIO, a Korean biotech company.  Under this agreement, Epis NexLab and G2GBIO will co-develop a long-acting microsphere drug delivery platform based on G2GBIO’s current technology, which includes its Innovative Long-Acting Microsphere Platform or InnoLAMP.  With InnoLAMP, drug products are encapsulated in biodegradable polymers that allow for the release of uniform microspheres of the drug over extended periods, such as over a week to several months. 

InnoLAMP Technology, G2GBIO (last accessed Mar. 19, 2026). 

In addition to the microsphere platform, the agreement grants Samsung Bioepis a full license to G2GBIO’s long-acting semaglutide asset and an option to license another G2GBIO asset.  The agreement also grants Samsung Bioepis first negotiation rights for three other novel assets, which will be determined at a later date.

This announcement follows Samsung Biologics’ statement earlier in the week that it had entered into a collaboration agreement with Eli Lilly and Company to establish a Lilly Gateway Labs site in Korea.  The agreement with Lilly is expected to provide research infrastructure for up to 30 biotech companies within Samsung Biologics’ Bio Campus II.  Construction is expected to be completed on the Lilly Gateway Labs facility in July 2027.    

The post Samsung Bioepis and Sandoz Expand Potential Portfolios Through New Research and Development Collaborations appeared first on Big Molecule Watch.

According to the complaint, Defendants have developed and plan to sell biosimilar versions of Janssen’s SIMPONI^® and SIMPONI ARIA^®, which Defendants have identified as BAT2506.  The complaint alleges that Bio-Thera is responsible for the development, manufacturing, and supply of BAT2506, and has entered into contracts under which it has received and will receive revenues and other financial compensation for the sale of BAT2506 in the United States.  The complaint also alleges that Accord will sell BAT2506 in the United States.

The complaint asserts 17 patents across 34 counts (one direct infringement count and one declaratory judgment count per patent).  The patents are generally directed to, among other things,  manufacturing and method-of-treatment patents.

The complaint asserts that the parties engaged in pre-litigation disclosures under the BPCIA (the so-called “patent dance”) including disclosure of the aBLA and other documents under 42 U.S.C. § 262(l)(2)(A).  However, Janssen alleges that, although Accord provided the aBLA for BAT2506, it failed to fully provide “such other information that describes the process or processes used to manufacture the biological product.”

The complaint further alleges that Janssen provided its list of patents which it believed a claim of patent infringement could reasonably be asserted consistent with 42 U.S.C. § 262(l)(3)(A).

Finally, according to the complaint, Defendants provided their non-infringement and invalidity disclosures and accompanying documents under § 262(l)(3)(B), but Janssen asserts that these disclosures failed to show that Defendants’ manufacture or sale of BAT2506 will not infringe the asserted patents.

In terms of relief, Janssen requests a judgment that Defendants have infringed Janssen’s patents under 35 U.S.C. § 271(e)(2)(C) by filing their aBLAs for BAT2506 and seeks to delay FDA approval of the aBLA until expiry of the asserted patents, an injunction, a determination that the case is willful and exceptional, costs and attorneys’ fees, and any available damages.

Stay tuned to Big Molecule Watch for further updates on this BPCIA case.

The post Update: Janssen Files BPCIA Complaint Against Bio-Thera and Accord Related to Golimumab Biosimilar appeared first on Big Molecule Watch.