Tony Hagen is senior managing editor for The Center for Biosimilars®.
With successful findings from a phase 3 trial of its bevacizumab biosimilar candidate, Iranian company AryoGen Pharmed is a step closer to commercialization of this product.
The importance of biosimilars worldwide is illustrated by the development of biosimilar manufacturing and development beyond the United States and Europe. In Iran, AryoGen Pharmed has a growing portfolio of biosimilars and aims to become a leader in the development of these medicines. Well established as a biopharmaceutical manufacturing center, AryoGen Pharmed has received a Good Manufacturing Practice certificate from the Europeans Medicines Agency.
Investigators described successful findings for the company’s bevacizumab biosimilar candidate, BE1040V, in a recent phase 3 clinical study in Clinical Therapeutics. The authors outline the product's potential value as a treatment for metastatic colorectal cancer (mCRC).
Biologics Improve mCRC Survival
They note that 5-year survival for patients with this disease is low at just 14%. However, overall survival with systemic chemotherapy in clinical trials has risen to 30 months from 11 months, and these gains have been aided by the introduction of newer chemotherapeutic agents, such as oxaliplatin and irinotecan, in combination with combination regimens such as fluorouracil and biologic agents.
“In fact,” the authors write, “only trials that have incorporated the use of biologic agents into regimens of combination therapies have consistently reported a median survival rate of over 24 months.”
Bevacizimab is one of the biologic agents that have been employed with success in the mCRC setting. The drug works by inhibiting vascular endothelial growth factor-A, which helps in the formation of blood vessels that are essential to the growth of tumors.
A biosimilar bevacizumab such as BE1040V can play an important role in making these advanced therapeutic combinations available to patients, the authors note. Biosimilars are highly similar to innovator brands and have no clinically significant differences with regard to tolerability and efficacy. The chief advantage of a biosimilar over an innovator product is its presumed greater affordability for patients and health care systems.
“Due to the considerable cost of the reference product bevacizumab and also the high mortality rate of mCRC in Iran, BE1040v was developed as a biosimilar of the reference product bevacizumab,” investigators wrote.
The just-published study demonstrated that the candidate bevacizumab biologic was noninferior to the reference product in terms of efficacy and tolerability.
For a full discussion of the study findings, visit AJMC.com.