On August 21, 2026, Alvotech announced a licensing and commercialization agreement with Lotus Pharmaceutical (“Lotus”) for AVT34, a proposed biosimilar to IMFINZI® (durvalumab), and AVT87, a proposed biosimilar to HEMLIBRA® (emicizumab).
In the United States, Alvotech and Lotus will have
Big Molecule Watch
Big Molecule Watch, published by Goodwin Procter, focuses on legal developments related to biologic drugs, biosimilars, and complex pharmaceutical products. The blog covers regulatory approvals, patent litigation, and market entry strategies for biosimilars and innovative biologic therapies. It reports on FDA and European Medicines Agency decisions, patent settlements, and industry trends affecting the life sciences sector. Topics include biosimilar launches, regulatory compliance, intellectual property disputes under the Biologics Price Competition and Innovation Act (BPCIA), and advancements in cell and gene therapies. The blog serves as a resource for legal professionals and industry stakeholders tracking the evolving landscape of biologic medicines.
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Biocon Announces Supplemental U.S. FDA Approval for Prefilled Autoinjector for YESINTEK
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Takeda Files BPCIA Suit Against Polpharma Biologics For Vedolizumab Biosimilar
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FDA Addresses FAQs on Developing Potential Cellular and Gene Therapy Products
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Biocon Launches Aflibercept Biosimilar in the United States
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FDA Revises Draft Guidance on Substantial Evidence of Effectiveness to Clarify Confirmatory Evidence Requirements for a Single Clinical Investigation
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