In 2018, Dr. Reddy’s indicated that it expected to initiate clinical studies for the bevacizumab biosimilar to facilitate EU and US regulatory approval, but this week, a company representative told The Center for Biosimilars® in an email that, “currently, we are gearing up for filings in emerging markets for Versavo.”
This week, Hyderabad-based Dr. Reddy’s Laboratories announced that it has launched a bevacizumab biosimilar, Versavo, in India. The anti-vascular endothelial growth factor therapy will be available in 100-mg and 400-mg vials.
Raymond De Vré, PhD, global head of biologics at Dr. Reddy’s, said in a statement that the biosimilar will help to improve access to high-quality therapy at an affordable cost to address the needs of patients in India who have a variety of different cancer types.
The drug was approved in India on the basis of a data package that included data from a comparative pharmacokinetic (PK) study of the biosimilar versus both the EU and US reference bevacizumab (Avastin) in healthy volunteers.
In the double-blind, parallel-group, phase 1 study, 149 healthy males were randomized to receive a single intravenous dose of the biosimilar, the EU reference, or the US reference. The primary endpoints included maximum observed serum concentration, area under the concentration-time curve from time zero to infinity, and area under the concentration-time curve from time zero to the last quantifiable concentration.
The primary PK parameters were comparable across groups, and the 90% confidence intervals for the geometric mean ratios of the primary PK endpoints were within the prespecified equivalence margin of 80% to 125% for all pairwise comparisons.
As for the next steps for the biosimilar, in June 2018, Dr. Reddy’s indicated in an investor presentation that it expected to initiate clinical studies for the bevacizumab biosimilar—as well as a rituximab biosimilar—with an aim of EU and US regulatory approval in the following 4 to 6 quarters. However, this week, a company representative told The Center for Biosimilars® in an email that, “currently, we are gearing up for filings in emerging markets for Versavo.”
Versavo is being manufactured at Dr. Reddy’s facility in Hyderabad, the same facility was issued a Form 483, with 5 observations, by the FDA last month.
Wynne C, Schwabe C, Batra SS, Lopez-Lazaro L, Kankanwadi S. A comparative pharmacokinetic study of DRL_BZ, a candidate biosimilar of bevacizumab, with Avastin (EU and US) in healthy male subjects. Br J Clin Pharmacol. 2018;84(10):2352-2364. doi: 10.1111/bcp.13691.