Biocon Biosimilar Quarterly Sales Up 106%

Biocon’s earnings report for the first quarter of fiscal year 2024 (Q1FY24) showed immense growth for the company’s biosimilars, which accumulated a 106% rise in sales compared with the same quarter in FY23.

The growth in biosimilar sales was largely attributed to the completed acquisition of Viatris’ biosimilar portfolio and growth in market share for products available in the United States and European Union, including the US launch of Hulio, 1 of 8 adalimumab biosimilars to enter the American market in 2023. As part of the Viatris acquisition, Biocon gained the rights to biosimilar products in over 70 countries, and Biocon confirmed that its next steps are to integrate the business in North America by the end of Q2FY24.

“Our key biosimilars are gaining traction in both US and Europe with Fulphila becoming the leading biosimilar pegfilgrastim in the US and biosimilar [insulin] glargine’s [Semglee] market share crossing the 12% mark. A higher new prescription share reflects the prescriber confidence in our portfolio and the overall improvement in the adoption of biosimilars,” commented Kiran Mazumdar-Shaw, executive chairperson at Biocon and Biocon Biologics, Biocon’s biosimilars business.

Overall, for the quarter, Biocon collected Rs 3516 Crore (US $423 million) in consolidated revenue, a 59% year-over-year increase from the same quarter the previous year. Core earnings for the quarter also rose 42% to Rs 936 Crore (US $112 million). Biosimilar accounted for 57% of the revenue, generics made up 20%, and the other 23% was attributed to research services.

Biosimilars alone acquired Rs 2015 Crore (US $242 million), more than double amount accumulated in Q1FY23 (Rs 977 Crore; US $117 million). Quarterly revenues for generics rose from Rs 607 Crore (US $73 million) in Q1FY23 to Rs 700 Crore (US $84 million) in Q1FY24, a 15% increase.

During the quarter, Biocon had 7 biosimilar product launches and 5 approvals in both advanced (North America and Europe) and emerging markets. Biocon biosimilars have been used to treat about 5.7 million patients around the world.

The company noted, “The revenues and margins for the quarter were impacted due to phasing of the tender business in emerging markets and higher rebates for [Fulphila] in the US, based on legacy contracts with select customers, which will normalize in the coming quarters.”

In North America, Fulphila has the highest market share compared with all other pegfilgrastim biosimilars, reaching 16%. Similarly, Ogivri, a trastuzumab biosimilar, has accumulated 11% market share and the branded and unbranded versions of Semglee, an insulin glargine biosimilar, together make up 12% market share. Biocon sells both a branded and unbranded version of the biosimilar to allow for marketing at different prices and easier access to pharmacy benefit manager formulary lists. Additionally, branded Semglee is indicated for interchangeability in the United States.

In Europe, Biocon’s Yesafili became the first aflibercept biosimilar to receive a positive opinion form the European Medicines Agency’s Committee for Medicinal Products for Human Use, and Biocon anticipates an official approval in the region by the end of September 2023. Furthermore, market shares for Ogivri, Hulio, Fulphila, and Abevmy (bevacizumab biosimilar) are rising throughout the European Union.

The emerging markets business was driven by a steady performance of its recombinant human insulin, insulin glargine, and trastuzumab biosimilars. Biocon products have won tender contracts in some countries in Latin America, Africa, and the Middle East.