Eli Lilly ($LLY) and Boehringer Ingelheim have convinced European regulators to recommend their biosimilar of Sanofi's ($SNY) Lantus, the world's top-selling insulin, setting the stage for a near-term approval and launch once the reference product comes off patent next year.
The European Medicines Agency's Committee for Medicinal Products for Human Use has stamped a positive opinion on the duo's Lantus knockoff, a long-acting insulin analog to be marketed as Abasria. The treatment has proven itself safe, effective and similar to Sanofi's product across 6 clinical clinical trials, regulators said, and a final opinion from the European Commission is expected in the next two months.
That's right on schedule for Lilly and Boehringer, at least in the EU, as the companies aim to launch their biosimilar right when Lantus loses its patent protection in 2015. The insulin remains Sanofi's major global cash cow, growing 20% last year to bring in about $7.6 billion.
However, only the European sales--about $1.1 billion in 2013--will be up for grabs for Lilly and Boehringer, as a Sanofi patent lawsuit has put their U.S. application on hold. Sanofi's action, filed in January, will block the pair from a stateside launch of Abasria until the middle of 2016 unless the parties can come to terms.
But the market for insulin analogs may look much different by then. Merck ($MRK), with the help of a joint venture between Samsung and Biogen Idec ($BIIB), is working up a Lantus biosimilar of its own. And Sanofi has already filed applications in the U.S. and EU for Toujeo, a long-acting Lantus successor that could hit the American market before Lilly and Boehringer can roll out their biosimilar.
In the short term, however, the CHMP opinion is a positive step for the diabetes alliance, and an eventual nod would make for Lilly and Boehringer's fourth European approval since joining forces in 2011.
"The CHMP's recommendation brings us a step closer to providing an important new option for the millions of patients in the EU who need basal insulin to help manage their diabetes," Lilly Diabetes President Enrique Conterno said in a statement. "This first-ever biosimilar insulin to receive a positive CHMP recommendation underscores Lilly and Boehringer Ingelheim's commitment to providing physicians and patients high-quality diabetes medicines, along with expertise and support tools they need to help manage the disease."
- read the CHMP release (PDF)
- here's Lilly's statement