Sanofi has worked hard to hold on to the big profits generated by its blockbuster insulin Lantus, but the onslaught of copies continues. Mylan and Biocon have now won an EU recommendation for approval of their biosimilar after overcoming manufacturing concerns that forced a delay last summer.
On Thursday, the Committee for Medicinal Products for Human Use (CHMP) recommended approval of Semglee for use in children and adults two years old and above. It will now be up to the EU to decide whether to grant approval.
Mylan and Biocon had their approval delayed after EU investigators found issues with the Biocon plant in India during a preapproval inspection for their biosimilars of Roche’s cancer med Herceptin, Amgen’s chemo drug Neulasta and the pen assembly that is to be used for Semglee. They withdrew the application in July after being told a reinspection would be required. The biosimilar itself is to be made at Biocon's insulin plant in Malaysia, which won EMA approval in September.
Mylan and Biocon won their nod a year to the day after Merck & Co. and its partner Samsung Bioepis won approval from the EU for their copy. Also, Eli Lilly and Boehringer Ingelheim launched their version in Europe in 2015.
The U.S. market is another matter. Sanofi sued Mylan in October, alleging its copy infringes 18 patents, and asked a court to intervene in the generic drug makers’ launch efforts.
But others are already threatening Sanofi's top moneymaker, a drug that reeled in €5.7 billion ($6.7 billion) around the world last year. Under a 2015 settlement, Eli Lilly launched its copy Basaglar in late 2016 and generated $278 million in the first nine months of 2017.
Merck has its own approved version of Lantus but can't launch it until 2019 due to a 30-month stay under the Hatch-Waxman Act that started ticking in September 2016. Alternatively, the company could launch earlier if it defeats Sanofi in patent court.