Mylan and Biocon’s biosimilar trastuzumab, which will be sold as Ogivri and which references Herceptin, today received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
Mylan and Biocon’s biosimilar trastuzumab, which will be sold as Ogivri and which references Herceptin, today received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
“Obtaining a positive CHMP opinion for Ogivri is another significant achievement in Mylan’s continued efforts to bring more affordable medicines to the market,” said Mylan president Rajiv Malik. “The strong science and technology program behind this product has been instrumental in achieving this milestone and moving us one step closer to providing patients with this alternative option.”
The positive opinion is based on a package that includes analytical data as well as preclinical and clinical studies. The results from the studies found that there were no clinically meaningful differences in terms of quality, potency, and safety. Findings from the phase 3 Heritage clinical trial demonstrated that no clinically meaningful differences were present with respect to safety, efficacy, or immunogenicity when the biosimilar was compared with the reference.
Ogivri is indicated for the treatment of patients with human epidermal growth factor receptor 2—positive early breast cancer, metastatic breast cancer, and metastatic gastric cancer.
The European Commission is expected to make a final decision regarding authorization by the end of 2018. Ogivri has already received regulatory approvals in 35 countries around the world, including the United States, where it earned FDA approval in 2017.
The product is not yet launched in the United States; while Mylan and Herceptin developer Roche reached a global settlement and license agreement in March 2017, it remains to be seen when the biosimilar will become available on the US market.
In looking to the future of the Mylan—Biocon partnership, Arun Chandavarkar, PhD, CEO and joint managing director of Biocon, said, “We shall continue to execute on our biosimilars strategy of expanding affordable access to high quality products targeting critical illnesses like cancer.”
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.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.