On April 4, 2024, Bristol Myers Squibb (“BMS”) and 2seventy bio, Inc. announced that the FDA has approved ABECMA (idecabtagene vicleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody.
Big Molecule Watch
Janssen v. Teva: Not an April Fool’s Day Joke for Life Sciences Companies
On April 1, 2024, the Federal Circuit released its opinion in Janssen Pharmaceuticals, Inc. et al v. Teva Pharmaceuticals USA, Inc. et al., affirming the district court’s finding that certain claims were not indefinite and remanding to the district court to reevaluate its obviousness decision. The Federal Circuit’s analysis provides important considerations for life sciences…
FDA Approves New Indication for AstraZeneca and Daiichi Sankyo’s Cancer Drug ENHERTU
By Emma Murray
On April 5, the FDA granted accelerated approval to AstraZeneca and Daiichi Sankyo’s ENHERTU (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. ENHERTU, which is now FDA-approved for five indications, is a specifically engineered HER2-directed antibody drug…
REGENXBIO and Sarepta Agree to Stay Litigation Pending Outcome of Sarepta’s IPR Petition
By Elaine Blais
As we previously reported, REGENXBIO Inc. and the Trustees of the University of Pennsylvania filed suit in Delaware in June 2023 against Sarepta Therapeutics, Inc., Sarepta Therapeutics Three, LLC, and Catalent, Inc., alleging infringement of U.S. Patent No. 11,680,274 by Sarepta’s gene therapy product, ELEVIDYS (delandistrogene moxeparvovec-rokl). On September 19, 2023, the Court issued…
Fresenius Kabi and Formycon Reach Settlement Agreement for Ustekinumab Biosimilar Candidate in Europe and Canada
On March 18, 2024, Fresenius Kabi (“Fresenius”) and Formycon announced a settlement agreement with Johnson & Johnson regarding FYB202, a proposed ustekinumab biosimilar to STELARA in Europe and Canada. The terms of the settlement are confidential. According to the press release, the settlement agreement aligns with Fresenius’s recent achievements in its Biopharma segment, reflecting its…
FDA Approves First Gene Therapy to Treat Children with Metachromatic Leukodystrophy
By Lihui Bai
On March 18, 2024, the FDA approved Orchard Therapeutics’ LENMELDY, the first approved gene therapy for the treatment of children with metachromatic leukodysrophy (MLD). MLD is a rare, fatal genetic disease affecting approximately one in every 40,000 individuals in the U.S. LENMELDY is made from patient’s own hematopoietic (blood) stem cells, and the genetically modified…
Biden Administration Proposes Biosimilar Substitution Without Interchangeability
The Biden Administration recently released a 2025 Budget Proposal which includes permitting biosimilar substitution without the Food and Drug Administration’s (“FDA”) separate determination of interchangeability. Specifically, the U.S. Department of Health & Human Services (HHS)’s 2025 proposed budget includes a budget-neutral provision for allowing biosimilar substitution without a separate determination of interchangeability. According to HHS,…
Women’s History Month Spotlight: Emmanuelle Charpentier and Jennifer Doudna
In honor of Women’s History Month, Big Molecule Watch recognizes Emmanuelle Charpentier and Jennifer Doudna, who won the Nobel Prize for a method for genome editing, commonly called CRISPR or “molecular scissors”. By sharing the 2020 Nobel Prize in Chemistry, Charpentier and Doudna were the first women-only Nobel team in the history of the award and…
Celltrion Announces Commercial Availability of ZYMFENTRA™ (infliximab-dyyb)
Celltrion Submits BLA for Omalizumab Biosimilar
Last week, Celltrion USA announced it had submitted a BLA for CT-P39, a biosimilar to XOLAIR (omalizumab). Phase 3 studies demonstrated that in patients with chronic spontaneous urticaria, CT-P39 and reference product XOLAIR (omalizumab) had comparable efficacy and safety. XOLAIR (omalizumab) is an injectable biologic that is approved in the United States for the treatment…