38.6c New Delhi, India, Sunday, May 19, 2024

Biocon Partner Mylan Gets Favorable Ruling in Patent Case on Insulin Glargine (Used in Diabetes)

By Parth Thummar      02 June, 2020 01:14 PM      0 Comments
Biocon Mylan Patent Case Insulin Glargine

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.

Share this article:

Leave a feedback about this

Trending Judiciary
SC notice to EC on plea by ADR for release of voters turnout data

SC issues notice to EC on ADR plea to release voter turnout data. SC demands EC to disclose vote counts within 48 hours after each phase of the 2024 Lok Sabha polls.

18 May, 2024 11:16 AM
Trending CelebStreet
Delhi HC refuses Jackie Shroff interim relief against Youtuber 'UnfilteredThugesh' for using "Thug Life" in video on Shroff

The Delhi High Court has refused Jackie Shroff interim relief against Youtuber 'UnfilteredThugesh' for alleged personality rights' infringement.

18 May, 2024 05:20 PM


Trending Judiciary
Indian Courts this Week: Law Street Journal's Weekly Round-Up of SC & HCs [May 6 - May 10]

Get the latest updates from India's Supreme Court and the High Courts ! Here’s a round up of the week's top legal stories in a quick, easy-to-read summary.

13 May, 2024 10:29 AM
Trending Judiciary
SC dismisses Union govt's plea against bail to Maoist financer in case of attack on police party in Jharkhand [Read Judgment]

SC rejects govt's plea against bail for accused in Jharkhand police attack case, citing absence of violated bail conditions.

13 May, 2024 11:33 AM
Trending Judiciary
Supreme Court upholds gang rape conviction, though victim turned hostile [Read Judgment]

SC upholds gang rape conviction despite victim's hostility, affirming witness credibility in criminal trials.

13 May, 2024 12:24 PM
Trending Judiciary
Sanatana Dharma remarks SC seeks response from UP, Maha, Ktka, Bihar, J&K on Udhayanidhi's plea for clubbing FIRs

SC seeks response on Udhayanidhi's plea for clubbing FIRs related to his remarks on 'Sanatan Dharma'.

13 May, 2024 12:39 PM


Join Group

Signup for Our Newsletter

Get Exclusive access to members only content by email