Henlius and Organon’s Perjeta® Biosimilar Candidate HLX11 Receives European Medicines Agency Validation
Shanghai, China and Jersey City, N.J., – In a significant step forward for the biopharmaceutical industry, Henlius Biotech (Henlius) and Organon & Co. (Organon) announced that the European Medicines Agency (EMA) has validated the filing for Henlius’ Perjeta® (pertuzumab) biosimilar candidate, HLX11. This validation marks the initiation of the regulatory review process for HLX11 in Europe.
About Perjeta® and Biosimilars
Perjeta® (pertuzumab) is a monoclonal antibody co-developed by Roche and Genentech. It is approved for use in combination with Herceptin® (trastuzumab) and docetaxel for the treatment of HER2-positive advanced or metastatic breast cancer. Biosimilars are biological medicines that have been approved based on demonstrating similarity to an already licensed reference product, in this case, Perjeta®. They offer an opportunity to increase patient access to effective treatments while reducing healthcare costs.
Impact on Patients
If approved, HLX11 will provide patients in Europe with a more affordable alternative to Perjeta®. This could lead to increased access to treatment for a larger number of patients, ultimately improving patient outcomes. The availability of biosimilars also allows for greater competition in the market, potentially driving innovation and further price reductions.
Impact on the World
The validation of the filing for HLX11 represents a critical milestone in the global biosimilars market. Europe is one of the largest markets for oncology treatments, and the approval of HLX11 could pave the way for similar approvals in other regions, including the United States and Japan. This could lead to significant cost savings for healthcare systems and increased access to effective cancer treatments worldwide.
Conclusion
Henlius and Organon’s announcement of the European Medicines Agency validation of the filing for HLX11, a biosimilar candidate for Perjeta®, marks an important step forward in the regulatory review process for this potential treatment option in Europe. If approved, HLX11 will offer patients a more affordable alternative to Perjeta® while increasing competition in the market and potentially driving further price reductions. The impact of this approval could extend beyond Europe, influencing the global biosimilars market and ultimately improving patient access to effective cancer treatments worldwide.
- Henlius and Organon announce EMA validation of Perjeta® biosimilar candidate HLX11
- HLX11 is a potential treatment option for HER2-positive advanced or metastatic breast cancer
- Biosimilars offer increased patient access and cost savings
- Approval of HLX11 in Europe could pave the way for similar approvals in other regions
- The impact of HLX11’s approval could lead to significant cost savings and increased patient access to effective cancer treatments worldwide
