International Biosimilar Launches: Ujvira and PrInclunox®

gloved hand withdraws drug solution with syringe

On May 24, 2021, Zydus Cadila launched the world’s first antibody drug conjugate (ADC) biosimilar.  The drug is a trastuzumab emtansine biosimilar—using Genentech’s Kadcyla as the reference product—that will be marketed under the name Ujvira for use in treating early and advanced HER2 positive breast cancer.  The drug is made by combining trastuzumab with emtansine (DM1) by using a stable linker, which enables targeted delivery and reduced toxicity.  Dr. Sharvil Patel, Managing Director, Cadila Healthcare Limited stated, “The launch of Ujvira reinforces the innovation capabilities that India has to be able to create complex therapies like ADCs and Zydus’ ongoing commitment to offer breakthroughs backed by science and innovation.”  It is estimated that Ujvira will be able to reduce treatment costs by up to 80%.

On May 17, 2021, Sandoz Canada launched PrInclunox® and PrInclunox® HP, enoxaparin sodium solutions for injection, marking the company’s sixth biosimilar launch.  PrInclunox® and PrInclunox® HP are anticoagulant biosimilars to Sanofi’s PrLovenox® and PrLovenox® HP and are indicated for the prophylaxis and treatment of deep vein thrombosis, among other conditions.  Michel Robidoux, President and General Manager of Sandoz Canada stated, “This launch is an important step as we pursue our ambition to become the leading biosimilars and generics company in Canada.”  Sandoz Canada has completed pre-Canadian Pharmaceutical Alliance negotiations and is actively working on securing reimbursement for public and private payors.  The drugs have been recommended by INESSS for placement on the List of Medications.