In the past year, Biocon received marketing approvals in the European Union for both its biosimilar pegfilgrastim (sold as Fulphila) and its biosimilar trastuzumab (sold as Ogivri), which were co-developed in a partnership with Mylan.
Last week, Biocon released its third quarter earnings for fiscal year (FY) 2019 on an earnings call with investors. Included within the earnings report were updates on Biocon’s biosimilar pipeline.
“Our biosimilars strategy is beginning to pay off with the launch of our biosimilars in the [United States] and [European Union], and we are greatly encouraged by the recent regulatory approvals of our key biosimilars in advanced markets like [the European Union], Australia, and Canada,” said Kiran Mazumdar-Shaw, chairperson and managing director of Biocon. “We are committed to [playing] a significant role in enhancing access to our high quality, affordable biologics for patients across the world.”
In the past year, Biocon received marketing approvals in the European Union for both its biosimilar pegfilgrastim (sold as Fulphila) and its biosimilar trastuzumab (sold as Ogivri), which were co-developed in a partnership with Mylan. Both Ogivri and Fulphila are approved in the United States, though only Fulphila has thus far reached the US market.
Additionally, the third quarter for Biocon also saw the launch of 2 of its co-developed biosimilar products in the European Union: insulin glargine, Semglee, and biosimilar adalimumab, Hulio.
Biocon’s biologics arm alone brought in nearly $6,317,879 in Q3. This figure is more than double that of Q3 FY18, equal to a growth of 136% year over year, according to Biocon.
Last quarter was notable for Biocon’s company as a whole, and it boasted that “We have delivered the highest ever revenue and profit growth in absolute terms in Q3FY19, driven by strong business performance. Our biologics segment more than doubled in revenue and recorded an [earnings before interest and taxes, EBIT margin] of 30% driven by increased penetration of our pegfilgrastim in US small molecules, branded formulations, and research services also registered a robust growth this quarter,” said Mazumdar-Shaw.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
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.
Eye on Pharma: Aflibercept Legal Drama; PBM, Humira Biosimilars; Denosumab Regulatory Review
October 15th 2024Regeneron appeals legal decision after judge refuses to block an aflibercept biosimilar; Prime Therapeutics, a pharmacy benefit manager (PBM), becomes the latest to offer biosimilars referencing Humira (adalimumab) at a low cost; the FDA and European Medicines Agency accept a denosumab biosimilar candidate for review.
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.
Sandoz Report: A Unified Approach to Overcoming Drug Shortages
October 10th 2024A report from Sandoz emphasizes the need for collaboration among stakeholders to eliminate drug shortages impacting over 90% of hospital systems in the US, recommending policy changes and actions to address the ongoing issue, which has caused treatment delays and increased costs.