Mylan Inc. (MYL) has become a tough competitor in the biosimilar glargine race after announcing that it will begin Phase-III trials to show the non-inferiority of its experimental drug glargine when compared to Sanofi SA’s (SNY) diabetes drug Lantus.
Lantus generated revenue of $7.6 billion in fiscal year 2013. It and Mylan’s experimental drug will be used to treat type 2 diabetes mellitus patients.
Mylan estimates that the trials will be conducted on 600 patients and will end by June 2016. The company further revealed that patients enrolled in the trials will be randomized to receive Mylan's insulin glargine and Lantus as a part of the comparative phase study. The trials will measure the efficacy of Mylan’s drug when prescribed in the same quantity as Lantus, and also its effects on patients.
The recommended initial dose of Mylan's insulin glargine or Lantus in type 2 diabetes mellitus patients not currently treated with insulin is 10 units (0.2 units per kg) once a day. This recommended dosage can be adjusted every subsequent week if need be. ClinicalTrials.gov states that the study will focus on blood glucose reduction and is expected to be completed by mid-2016.
However, Mylan is not the only company looking to launch a drug similar to Lantus, whose patent will expire next February. Another contender in the race is Eli Lilly and Co. (LLY). As of now, it seems that Eli Lilly leads the biosimilar glargine race. The company’s experimental drug LY2963016 has proven to be efficient in treating type 2 diabetes mellitus patients. Data from two Phase-III trials of Lilly’s copy of Lantus showed that its drug had the same blood sugar controlling abilities. Furthermore, the ELEMENT-1 and ELEMENT-2 trials showed that all the drugs had the same hypoglycemia rates. All this was achieved with the same dose of insulin.
While there were some numerical differences, the trial's statistical requirements met the FDA’s requirements for approval as a generic copy. It is likely that the drug will be launched in 2016.