Litigation, Launch, and Lower Costs: 3 Big Moves in the US Biosimilar Space

Discover the latest advancements in the biosimilar landscape, including the first patent lawsuit regarding a petuzumab biosimilar, a new ustekinumab biosimilar launch, and a new strategy for unbranded biosimilar access.

Genentech Initiated First Pertuzumab BPCIA Complaint

Genentech and Hoffman-La Roche have filed the first patent infringement case concerning another manufacturer developing a pertuzumab biosimilar.1 The complaint was filed in the US District Court of New Jersey against Shanghai Henlius Biotech and Organon. According to the filing, Genentech alleges that Henlius’s proposed pertuzumab biosimilar, for which Organon holds commercialization and distribution rights, could reasonably infringe 24 patents for Gentench’s originator (Perjeta). Genentech is seeking various forms of relief, including:

1. Judgments of infringement
2. Preliminary and/or permanent injunctions
3. Damages
4. Attorneys' fees

The case marks the first for the pertuzumab market but follows the litigation patterns seen in the adalimumab, ustekinumab, and etanercept markets that have led to delayed market launches and prolonged monopolies.2

Accord BioPharma Launches Imuldosa (Ustekinumab-srlf)

Accord BioPharma, the US specialty division of Intas Pharmaceuticals, announced the commercial launch of Imuldosa (ustekinumab-srlf).3 This biosimilar to Stelara (ustekinumab) marked Accord BioPharma’s third in-market biosimilar and received FDA approval for all the same indications as the reference product, including:

• Moderate to severe plaque psoriasis in adult and pediatric patients (6 years and older)
• Active psoriatic arthritis in adult and pediatric patients (6 years and older)
• Moderately to severely active Crohn disease in adult patients
• Moderately to severely active ulcerative colitis in adult patients

Imuldosa prefilled syringes were priced at the lowest wholesaler acquisition cost among all branded ustekinumab biosimilars, offering a significant discount from Stelara. The vial formulation also offered a considerable discount. The company also offered a $0 co-pay program for eligible patients so that more people living with plaque psoriasis, psoriatic arthritis, and Crohn disease and ulcerative colitis could receive a proven targeted biologic therapy. Accord BioPharma aimed to expand access to high-quality, more cost-effective biologic therapies, furthering its commitment to the immunology franchise.

MedImpact Introduced Unbranded Ustekinumab-aekn Biosimilar

MedImpact Holdings Inc. revealed its plan to provide access to an unbranded ustekinumab-aekn biosimilar, an interchangeable biosimilar to Stelara.4 This biosimilar would be available at a significantly lower cost than the reference product. Distributed by Anda, an affiliate of Teva Pharmaceuticals USA, the biosimilar would be directly purchasable by any licensed specialty pharmacy from MedImpact’s preferred partner, Birdi.

The unbranded strategy was designed to bypass traditional supply chain costs, aiming to deliver greater value to pharmacies and payers, and to offer a more affordable treatment option for patients by enhancing price transparency and reducing reliance on rebates. The unbranded ustekinumab-aekn biosimilar was anticipated to be available for purchase.

References

1. Genentech files first pertuzumab BPCIA complaint against Shanghai Henlius and Organon. Big Molecule Watch. August 18, 2025. Accessed August 18, 2025. https://www.jdsupra.com/legalnews/genentech-files-first-pertuzumab-bpcia-3305474/

2. Jeremias S. Breaking down biosimilar barriers: the patent system. The Center for Biosimilars®. November 11, 2025. Accessed August 18, 2025. https://www.centerforbiosimilars.com/view/breaking-down-biosimilar-barriers-the-patent-system

3. Accord BioPharma announces commercial launch of Imuldosa (ustekinumab-srlf) prefilled syringes at lowest WAC price among branded biosimilars to Stelara (ustekinumab). News release. Accord Biopharma. August 18, 2025. Accessed August 18, 2025. https://www.prnewswire.com/news-releases/accord-biopharma-announces-commercial-launch-of-imuldosa-ustekinumab-srlf-prefilled-syringes-at-lowest-wac-price-among-branded-biosimilars-to-stelara-ustekinumab-302531289.html

4. MedImpact offers low cost, unbranded ustekinumab-aekn biosimilar. News release. MedImpact. August 18, 2025. Accessed August 18, 2025. https://www.medimpact.com/clients/resources/press-releases/medimpact-offers-low-cost-unbranded-ustekinumab-aekn-biosimilar