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.
Eye on Pharma: Bevacizumab Update; Samsung Bioepis, J&J Settlement; Another EU Trastuzumab
December 6th 2023Outlook Therapeutics provides an update on the development of its bevacizumab candidate for age-related macular degeneration; Samsung Bioepis settles with Johnson & Johnson (J&J) over its ustekinumab biosimilar candidate; and the European Union gains another trastuzumab biosimilar.
Biosimilar Business Roundup for October 2023—Podcast Edition
November 5th 2023On this episode, we discuss the biggest news to come out of October 2023, including 3 regulatory approvals, 2 complete response letters, and new data and industry insights that have the potential to impact the entire US biosimilar industry.
CVS Caremark Switches Up Biosimilar Coverage in 2024
November 27th 2023As new biosimilars are added to CVS Caremark’s standard formulary, others are removed. One notable change is with the Humira biosimilars: the pharmacy benefit manager has removed Amjevita in favor of Hyrimoz and an unbranded biosimilar.
Biosimilars Business Roundup For August 2023—Podcast Edition
September 5th 2023On this episode, we’re giving an overview of some of the biggest stories in the business space regarding biosimilars, like the approval of the first neurology biosimilar, growth projections from company quarterly expense reports, and some analyses about the health of the market.
AMCP Nexus: Panelists Share Current Scope of Biosimilar Industry
October 26th 2023Panelists at the Academy of Managed Care Pharmacy (AMCP) Nexus meeting chronicled the current state of the US biosimilar market, including current policies impacting the market, recent regulatory decisions, and the developing arguments around requirements for clinical efficacy studies.