EU committee recommends approval of Biocon-Mylan’s insulin glargine

Livemint,  Jan 29 2018 By Isha Trivedi, Mumbai

Biocon Ltd and Mylan N.V. said on Monday that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion and recommended approval of insulin glargine injection, co-developed by the companies, for diabetes treatment.
The CHMP’s positive opinion will be considered by the European Commission and the regulator’s decision on approval of this product, to be sold under the name Semglee, is expected in April, the companies said in a joint press release.
As part of the marketing authorization application to the EU regulator, the companies had submitted requisite data to show similarity of its insulin glargine to the reference product, Lantus, of Sanofi.
“This (CHMP’s recommendation) is an outcome of our commitment to be a credible, global insulins player on the back of significant investments together with our partner Mylan in global scale manufacturing and R&D (research and development) after having previously obtained approvals for our insulin glargine in Japan and key emerging markets,” Arun Chandavarkar, chief executive officer and joint managing director of Biocon, said.
About 60 million people are estimated to have been living with diabetes in the European region.
Apart from EU, the companies have filed marketing applications for insulin glargine in Australia, Canada, and the US.
“Once Biocon-Mylan gets the approval, it will be the third player after Merck-Samsung (2017) and Eli Lilly-BI (2016) in the insulin glargine market in Europe. Next in line are pegfilgrastim and trastuzumab approvals in Europe which should come in second half of 2018,” Edelweiss Securities said in a note.
Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and insulin analogs. Glargine is one of the three insulin analogs being co-developed by the companies.
Mylan has exclusive commercialization rights for insulin glargine in the US, Canada, Australia, New Zealand, the European Union and European Free Trade Association countries, while Biocon has exclusive rights for Japan and a few emerging markets, and co-exclusive commercialization rights with Mylan in the rest of the world.
On Monday, shares of Biocon ended up 1.23% at Rs.614.80 on the BSE, while benchmark Sensex index closed up 0.65% at 36,283.25 points.

Comments

Post a Comment

Popular posts from this blog

India Joins Russia in Voting Against West-Backed Move to Expand Powers of OPCW

The Wire: June 28, 2018 New Delhi: India voted against a UK-backed move that will allow the global chemical weapons watchdog to apportion blame for illegal attacks, criticising the decision to grant “unchecked powers” to the head of the group which could be used for “partisan” purposes. On Wednesday, more than two-thirds of the member states of the Organisation for the Prohibition of Chemical Weapons (OPCW) voted to authorise the international body to identify the perpetrators and sponsors of a chemical weapons attack. It also specifically called on the OPCW’s technical secretariat to begin work on identifying the perpetrators behind the use of chemical weapons in Syria. The draft decision, sponsored by 30 countries, was adopted at the fourth special session of the conference of the states parties to the Chemical Weapons Convention at the Hague, with 82 in favour and 24 negative votes. While Europe, the United States and their allies voted ‘yes’, there was strong oppo...
Read more

As financial insecurity rises in urban India, so does investment in insurance

Image
Scroll.in March 13, 2020 Urban Indians are becoming less confident about their financial security. Up to 58% of them fret over financial independence post retirement, which is a 4% increase from last year. An equal share of urban Indians worry about meeting their daily medical expenses and sustaining their current lifestyle once they stop working. The findings are part of a survey published by Delhi-based Max Life Insurance in association with London-based consultancy Kantar. The firms surveyed 7,014 respondents in 25 cities, including six metros, nine tier-1 cities, and 10 tier-2 cities, between December 2019 and January 2020. Source: Max Life Insurance via Quartz The trends Source: Max Life Insurance via Quartz Source: Max Life Insurance via Quartz Source: Max Life Insurance via Quartz A significant share of urban Indians also say their families will have no financial support in the event of the breadwinner’s death. In such a scenario, around 57% believe the family sav...
Read more

ED tracks Swiss Bank A/Cs of Agusta scamster

The Poineer February 10,2019 Rakesh K Singh The Enforcement Directorate (ED) has tracked a dozen Swiss bank accounts in the name of Rajiv Saxena, who is key accused in the Rs 3,600 crore AgustaWestland VVIP chopper scam. The ED has also found out accounts held by  his family members and associates where the kickbacks in the now scrapped deal were allegedly parked. Two bank accounts are in the name of Rajiv Saxena’s  associates Pankaj Jain and Sumita Jain who are also the authorised signatories. The  third is in the name of another associate Ajit Singh Bubber, but Rajiv and his family members are authorised signatories. The remaining nine accounts are largely owned and operated by Rajiv, his family members and associates. Rajiv Saxena was deported by the UAE authorities on January 30 and the ED formally arrested him the next day and a court later granted his remand to the agency. He is currently undergoing custodial interrogation by the ED. The agency had in 2017...
Read more