In a boost to Biocon's Insulin glargine application in the US, partner Mylan has got a favorable ruling from the US Patent and Trademark Appeal Board (US PTAB) in its case against Sanofi. Sanofi is the innovator of insulin glargine.
The US Patent Office has ruled in favor 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 one application pending 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 is expecting to launch the drug in the US markets by this 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 projected to be 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 prescribe 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.