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
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2023-2024 Key Trends and Updates: Securities Litigation Against Life Sciences Companies Webinar
In this webinar, Caroline Bullerjahn, Tucker DeVoe, and Justin Ward from Goodwin, and Frank Schneider from Cornerstone Research will discuss key updates and recent trends concerning securities class actions filed against publicly traded pharmaceutical, biotechnology, medical device and…
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…
Celltrion Announces Commercial Availability of ZYMFENTRA™ (infliximab-dyyb)
Celltrion USA announced on March 18, 2024, the availability of ZYMFENTRA (infliximab-dyyb), a subcutaneous (SC) formulation of infliximab. ZYMFENTRA, approved by the FDA in October 2023, is the first FDA-approved SC infliximab for the treatment of moderately to severely active…
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…
Chamber of Commerce Sues CFPB To Eliminate or Enjoin $8 Late Fee Cap
Last week, the U.S. Chamber of Commerce (Chamber) joined five other trade associations to sue the Consumer Financial Protection Bureau (CFPB) and its director Rohit Chopra in Texas Federal District Court, seeking a court order declaring a recent CFPB rule…
Fresenius Kabi Announces FDA Approval of TYENNE, a Tocilizumab Biosimilar Referencing ACTEMRA
On March 7, Fresenius Kabi announced that the FDA has approved its tocilizumab biosimilar, TYENNE (tocilizumab-aazg) for inflammatory and immune diseases indications including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. TYENNE is the…
FDA’s Laboratory Developed Test (LDT) Final Rule Under OIRA Review
On March 1, 2024, the Office of Information and Regulatory Affairs (“OIRA”), Office of Management and Budget (“OMB”), Executive Office of the President received the final version of FDA’s rule on regulation of laboratory developed tests (“LDTs”) for administrative review. …
Major Life Sciences Licensing Deal Trends in China in 2023
This is the first of two articles focused on 2023 life sciences deals in China. The second article, which is coming soon, looks at trends in M&A.
In 2023, there were 240 reported life sciences licensing deals in China, an…
USPTO’s New Guidance on AI-Assisted Inventions: The Impact on the Use of AI in the Life Sciences
On February 12, 2024, the US Patent Office and Trademark Office (USPTO) released the Inventorship Guidance for AI-assisted Inventions (the Guidance). We previously discussed the Guidance here.
Following up on the Guidance, the USPTO released two examples…