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.
Reference
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.
Overcoming Challenges to Improve Access and Reduce Costs
November 12th 2024Biosimilars hold the potential to dramatically lower health care costs and improve access to life-changing treatments, but realizing this potential will require urgent policy reforms, market competition, and better education for both providers and patients.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo
November 7th 2024For the first time, Skyrizi (risankizumab-rzaa) has replaced Humira (reference adalimumab) as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Panelists Stress Stakeholder Education to Build Confidence in Biosimilars
October 31st 2024By expanding educational initiatives to clarify biosimilar safety, efficacy, and interchangeability, stakeholders can foster trust, improve access, and ensure that biosimilars are widely accepted as high-quality, cost-effective alternatives to originator biologics.