Pipeline Updates for Follow-on Insulin Products: Biocon/Mylan and Polus

On February 21, 2018, Biocon reported that the FDA issued a Form 483 with six observations after the FDA completed a pre-approval inspection of the facility where Biocon plans to manufacture, in collaboration with Mylan, its follow-on insulin version of Lantus.  Biocon indicated that it intends to respond to the FDA in a timely matter.

On February 26, 2018, according to the Korea Herald, Polus BioPharm said that it will issue convertible bonds worth $18,600,000 to fund production of a follow-on/biosimilar version of Lantus.  Polus plans to use the funds to complete its new manufacturing plant, where its product will be produced for clinical trials.  It also plans to file investigational new drug applications with both the FDA and the EMA.  A Polus official is quoted as saying that Polus “plan[s] to expand [its] market share by offering up to a 50 percent discount compared to the original drug.”

Download PDF