Tony Hagen is senior managing editor for The Center for Biosimilars®.
Biocon had a busy quarter, which included the launch of a long-acting insulin glargine product (Semglee) in partnership with Mylan.
Biocon, which launched an insulin glargine product on the US market in August, reported increased revenue of $238 million for the quarter just ended, driven by 11% growth in biosimilar sales, as well as growth in research services (12%) and generics revenue (8%). The net profit was $23.6 million.
Revenue for the company’s biosimilar products totaled $91.5 million, up from $82.2 million. Biocon has commercialized biosimilar versions of trastuzumab, pegfilgrastim, bevacizumab, and adalimumab in markets around the world. Besides insulin glargine, it also produces rh-insulin.
Highlights of the Quarter
During the quarter ended September 30, Biocon launched the long-acting insulin glargine product Semglee in partnership with Mylan. Because it was approved by the FDA under the Food Drug and Cosmetic Act and not via the biosimilar pathway established under the Biologics Price Competition and Innovation Act, the agent is not officially considered a biosimilar, although Biocon and Mylan have announced intentions of seeking biosimilar and interchangeable status for the product on the US market.
Interchangeable status would allow pharmacists to dispense the product as a substitute for the reference product Lantus without the need to obtain clearance from the prescribing physician.
“Our insulin glargine, Semglee, was commercialized in the United States by our partner Mylan during the quarter, thus heralding our entry into the US insulins market,” Biocon Executive Chair Kiran Mazumdar-Shaw said in the earnings statement. “With this launch, we have expanded our portfolio of biosimilars and occupy a position of impactful influence in the biosimilars segment.”
Semglee was launched in Spain over the past quarter. In addition, Mylan and Biocon launched an etanercept biosimilar in Europe, and Biocon aims to establish commercial offices in Brazil, Malaysia, United Arab Emirates, and Saudi Arabia.
Biocon said the quarterly growth in biosimilars revenue was led by its trastuzumab biosimilar (Ogivri), which the company said has a 6% share of the US market for trastuzumab (4% and 10% in the 150- and 420-mg product segments, respectively) and pegfilgrastim (Fulphila), which has a 15% share of the prefilled syringe market in the United States.
“Ogivri continues to be the leading biosimilar trastuzumab in Australia and Canada, and it has a double-digit share in 3 markets in Europe,” Biocon said. “For Semglee…we are witnessing encouraging market penetration in certain markets, such as Slovakia and Croatia.”