Alvotech and Teva’s Golimumab Biosimilar: A New Hope for Patients
In a thrilling turn of events, Reykjavik, Iceland-based Alvotech and Parsippany, New Jersey-based Teva Pharmaceuticals have made waves in the biotech industry with their latest collaboration. The duo announced on January 27, 2025, that the US Food and Drug Administration (FDA) has accepted for review their Biologics License Applications (BLA) for AVT05, Alvotech’s proposed biosimilar to Simponi® and Simponi Aria® (golimumab). This marks the first US BLA filing acceptances for a biosimilar candidate to golimumab, a monoclonal antibody used to treat various inflammatory conditions.
What’s the Big Deal About Golimumab?
Golimumab is a tumor necrosis factor (TNF) inhibitor, which works by blocking the action of TNF, a protein that plays a major role in inflammation. It is used to treat conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and Crohn’s disease. The original drug, Simponi® and Simponi Aria®, are manufactured by Janssen Biotech, Inc., a subsidiary of Johnson & Johnson. Biosimilars are essentially generic versions of biologic drugs, which are usually more affordable and offer increased competition in the market.
Implications for Patients
For patients, the acceptance of these BLA filings is a significant step towards more affordable treatment options for inflammatory conditions. If approved, AVT05 could potentially offer cost savings for patients and healthcare systems. As per a report by QuintilesIMS, the global market for biosimilars is expected to reach $31 billion by 2022, with North America accounting for the largest share. The entry of biosimilars in the market can lead to a reduction in healthcare costs and increased access to treatment for patients.
Global Impact
The acceptance of these BLAs is not only a victory for Alvotech and Teva but also for the global biotech industry. This collaboration signifies the growing importance of Iceland as a hub for biotech innovation and the increasing role of partnerships between international companies in driving the development of biosimilars. As per a report by the European Commission, the EU biosimilars market is expected to reach €52.4 billion by 2025. With the US market also opening up to biosimilars, the potential for growth is immense.
Conclusion
The acceptance of Alvotech and Teva’s BLA filings for AVT05, a proposed biosimilar to golimumab, marks an exciting milestone in the biotech industry. This collaboration could lead to more affordable treatment options for patients with inflammatory conditions and contribute significantly to the growth of the biosimilars market in both the US and Europe. As the world continues to grapple with rising healthcare costs, the entry of biosimilars into the market is a welcome development. So, here’s to a future filled with more affordable and accessible treatments!
- Alvotech and Teva announce acceptance of BLA filings for AVT05, a proposed biosimilar to golimumab
- This marks the first US BLA filing acceptances for a golimumab biosimilar
- Golimumab is a TNF inhibitor used to treat inflammatory conditions
- Biosimilars offer cost savings and increased competition in the market
- The global biosimilars market is expected to reach €52.4 billion by 2025
