Reykjavik, Iceland, October 5, 2026
Alvotech has announced that the U.S. Food and Drug Administration (FDA) has approved additional manufacturing capacity for SIMLANDI® (adalimumab-ryvk), the company’s biosimilar to Humira® (adalimumab). The approval expands the manufacturing capabilities available for SIMLANDI and represents an important milestone for Alvotech as it continues to strengthen the supply of its high-concentration, interchangeable adalimumab biosimilar in the United States. The additional capacity is expected to support greater manufacturing flexibility and help meet demand for the medicine as biosimilar adoption continues to grow in the U.S. pharmaceutical market.
FDA Approves Additional SIMLANDI Manufacturing Capacity
The FDA approval covers additional manufacturing capacity for SIMLANDI, enabling Alvotech to increase the available production capabilities supporting the U.S. market. SIMLANDI is an FDA-approved interchangeable biosimilar to Humira, a widely used biologic medicine based on adalimumab. The expansion is particularly significant because reliable manufacturing capacity is essential for biosimilars as companies seek to provide consistent supply and expand patient access to biological medicines. Alvotech has developed an integrated approach to biosimilar production, with research, development and manufacturing capabilities designed to support its portfolio of complex biologic products. The company’s manufacturing infrastructure is intended to provide greater control over production processes and supply planning. The newly approved capacity adds another manufacturing option for SIMLANDI and strengthens Alvotech’s ability to support the product’s commercial supply in the United States. The regulatory approval also demonstrates the importance of FDA manufacturing oversight in the production of biologic medicines. Manufacturing sites and processes must meet stringent quality requirements to ensure that products consistently meet specifications for identity, purity, potency and safety. For biosimilars, maintaining robust manufacturing controls is especially important because these medicines are highly complex biological products.
SIMLANDI Expands Access to Humira Biosimilar
SIMLANDI (adalimumab-ryvk) is a biosimilar version of Humira, which has been widely used to treat several inflammatory and immune-mediated conditions. As an interchangeable biosimilar, SIMLANDI meets additional regulatory standards that allow it to be substituted for its reference product at the pharmacy level, subject to applicable state and federal requirements. The availability of interchangeable biosimilars can contribute to increased competition within the biologic medicines market. Greater competition can support broader treatment access and potentially reduce healthcare costs, particularly for therapies that have historically represented a substantial expense for patients and healthcare systems. SIMLANDI is supplied as a high-concentration formulation, reflecting the evolution of adalimumab biosimilars toward formulations designed to provide convenient administration. Alvotech has continued to expand its U.S. commercial strategy around SIMLANDI as the biosimilar market develops and healthcare providers gain greater experience with alternative biologic therapies.
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Alvotech Strengthens Biosimilar Manufacturing Network
The latest approval forms part of Alvotech’s broader strategy to establish a global manufacturing platform for biosimilars. The company focuses on developing and manufacturing complex biological medicines, including products intended to address autoimmune diseases and other conditions requiring biologic treatment. For biosimilar developers, manufacturing scalability represents a critical component of commercialization. Successful development of a biosimilar must be supported by the ability to manufacture the product consistently at commercial scale while maintaining stringent quality standards. The FDA’s approval of additional SIMLANDI capacity therefore represents not only an expansion of production capability but also an important step in supporting long-term U.S. supply.
As biosimilar competition continues to expand in the United States, manufacturing capacity will remain an important factor in determining the availability of these medicines. Alvotech’s expanded capacity for SIMLANDI positions the company to support continued commercialization of its adalimumab biosimilar while strengthening its broader role in the global biosimilars market. The development is particularly relevant to the pharmaceutical industry because it combines FDA regulatory approval, biologic manufacturing, biosimilar commercialization and patient access. With additional capacity now approved, Alvotech can continue scaling its SIMLANDI supply while maintaining the quality and regulatory standards required for biological medicines in the U.S. market.
Source: Alvotech press release
