In a boost to Biocon's Insulin glargine application in the US, its partner Mylan got a favourable ruling from the US Patent and Trademark Appeal Board (US PTAB) in its case against Sanofi , the innovator of insulin glargine.

The US Patent Office ruled in favour of Mylan for a total of four device patents on Sanofi’s Lantus SoloSTAR. Lantus SoloSTAR is the disposable injection pen version of the drug. The other version by Sanofi—Lantus—is sold in the form of vials.

Biocon and Mylan have a pending application for insulin glargine, which is the biosimilar version of Sanofi’s Lantus with the US Drug Regulator. Biocon’s version of insulin glargine is branded as Semglee. The drug insulin glargine is a long-acting insulin used to manage both Type 1 and Type 2 diabetes.

Biocon and Mylan are currently awaiting the US drug regulator’s final nod for insulin glargine. Biocon expects to launch the drug in the US markets by the middle of this calendar year. According to the CEO and Managing Director of Biocon Biologics, Dr Christiane Hamacher, the ruling ‘further clears the path’ for the launch of insulin glargine in the US.

According to analysts, the market size of insulin glargine is a little over $2 billion for the US. Currently, this market size is split between two companies Sanofi and Eli Lily. Lily’s version of the drug was available in most countries around 5 years ago and is sold under the brand names Basaglar and Abasaglar.

One of the key challenges that Biocon faces on insulin glargine is the lack of an interchangeable status. That means a doctor needs to specifically write a prescription for Semglee and it cannot be sold as a replacement for Lantus or Basaglar. That means Mylan is probably going to have to promote the drug which could even become unviable later on.

As of now, the street will watch if Mylan will be granted interchangeability status. If it does get granted the status for the vial version of Lantus, then Mylan could make around $60 to $80 million in sales from the vial version drug.

First Published:Jun 1, 2020 1:10 PM IST