Biocon Biologics and Viatris Inc. Receive Historic Approval for First Interchangeable Biosimilar Semglee® (insulin glargine-yfgn injection) for the Treatment of Diabetes
Interchangeable Designation Allows Substitution at the Pharmacy Counter for Lantus® Across the U.S. to Help Increase Access to Medicines for People Living with Diabetes
Company is Eligible for 12 Months of First Interchangeable Exclusivity from the Date of Commercial Launch
Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) and Viatris Inc. (NASDAQ: VTRS) and today announced that the U.S. Food and Drug Administration (FDA) has approved Semglee ® (insulin glargine-yfgn injection) as the first interchangeable biosimilar product under the 351(k) regulatory pathway.
Biocon Biologics, Executive Chairperson, Kiran Mazumdar-Shaw said: “We are extremely proud to be the first to obtain approval of an interchangeable Biosimilar product in the U.S. It is a milestone achievement for both Biocon Biologics and our partner Viatris. This will allow pharmacy level substitution and thereby provide convenient and affordable access to Semglee, a quality Biosimilar Insulin Glargine.”
Biocon Biologics Managing Director Arun Chandavarkar said: “This interchangeability approval for Semglee by the U.S. FDA, another first to our credit, is a testament to our scientific excellence and robust quality comparability data. This allows substitution at the pharmacy counter, thus expanding patient access and sets the stage for future approvals for our other insulin products.”
The interchangeable Semglee product, which will allow substitution of Semglee for the reference product, Lantus®, at the pharmacy counter, will be introduced before the end of the year. The company is eligible to have exclusivity for 12 months before the FDA can approve another biosimilar interchangeable to Lantus. Commercial preparations for launch are underway. Over the next few months, Viatris will transition the current product to the 351(k) interchangeable product.
Semglee is indicated to control high blood sugar in adults with Type 2 diabetes and adults and pediatric patients with Type 1 diabetes. It is not recommended for the treatment of diabetic ketoacidosis. Semglee has an identical amino acid sequence to Lantus and is
Infosys to Implement its Cobalt-powered IaaS Solution for Select Portfolio Servicing Inc. in Collaboration with Hitachi Vantara
the global leader in nextgeneration digital services and consulting, today announced the renewal of its strategic collaboration with Select Portfolio Servicing Inc. (SPS) to implement its Cobalt-powered infrastructure as a service (IaaS) solution in collaboration with Hitachi Vantara. Through this engagement, Infosys will offer SPS next generation hybrid cloud, infrastructure services, and application services for the next five years.
As SPS’ strategic partner, Infosys will leverage its Cobalt portfolio to design, build, operate, and automate a robust and resilient private cloud infrastructure as a service with on-demand flexibility and scalability. Furthermore, Infosys intends to implement hybrid cloud to maximize data centre flexibility underpinned by enhanced disaster recovery and security posture.
Murali S. Palanganatham, Chief Information Officer at Select Portfolio Servicing, Inc. stated, “We have forged a strong collaboration with Infosys over the years, which has enabled us to leverage a repertoire of services & capabilities encompassing Application development, IT operations, IaaS, SaaS and Security. By resorting to Infosys’ Cobalt solutions and leveraging their expertise in integrated infrastructure, applications, IT operations and services, we intend to continuously scale, increase performance, enhance flexibility of our technology ecosystem, and streamline IT operations, augmented by automation.”
Narsimha Rao Mannepalli, Executive Vice-President, Head of Cloud & Infrastructure Solutions, Infosys said, “Being future-ready is key to survive and compete in the current business environment. We are excited to extend our collaboration with SPS and explore new avenues for leveraging our Cobalt portfolio to address a range of technology needs on-demand in an efficient, timely, and agile manner.”
Mark Ablett, Chief Revenue Officer, Hitachi Vantara said, “We are thrilled to utilize our EverFlex infrastructure as-a-service offering in partnership with Infosys to design and operate a modern and resilient hybrid cloud transformation for SPS’s regulated financial workloads. The ability to deliver a flexible consumption model for new storage and data services will enable SPS to innovate at scale and quickly address the needs of their growing customer base.”
HCL Earns 2021 Great Place to Work Certification
HCL America Inc, a wholly owned subsidiary of HCL Technologies (HCL), a leading global technology company, is proud to be Certified™ by Great Place to Work® for 2021. The prestigious award is based entirely on what current employees say about their experience working at HCL America. This year, 78 percent of its employees in the United Stated said it’s a great place to work – 19 points higher than the average U.S. company.
Great Place to Work® is the global authority on workplace culture, employee experience, and the leadership behaviors proven to deliver market-leading revenue, employee retention and increased innovation.
According to Great Place to Work research, job seekers are 4.5 times more likely to find a great boss at a Certified great workplace. Additionally, employees at Certified workplaces are 93 percent more likely to look forward to coming to work and are twice as likely to be paid fairly and have a fair chance at promotion.
Additional key highlights of HCL America results include:
• 86 percent people at HCL America felt they are given a lot of responsibility
• 86 percent of the employees said they can take time off from work when it’s necessary
• 85 percent of the employees say management trusts people to do a good job
• 85 percent of those surveyed considered management as honest and ethical in its business
practices
• 85 percent of employees say when they look at what they accomplish, they feel a sense of pride
“Great Place to Work Certification™ isn’t something that comes easily – it takes ongoing dedication to the employee experience,” said Sarah Lewis-Kulin, vice president of global recognition at Great Place to Work. “It’s the only official recognition determined by employees’ real-time reports of their company culture. Earning this designation means that HCL is one of the best companies to work for in the country.”
“We are thrilled to become Great Place to Work-Certified™ as we are intensely committed to providing our employees an inclusive, diverse and highly engaging environment,” said Ramachandran Sundararajan, Executive Vice President and Head of HR, HCL America. “We owe our continued success and growth to our talented and passionate employees across the nation. We are grateful for all they do and continue to encourage a focus on innovation and embracement of an entrepreneurial mindset.”
HCL Technologies has more than 30 years of history in the United States, with a nationwide workforce of around 17,000 employees and multiple global delivery centers and innovation labs. The company’s strong collaboration with clients, alliance partners, government and academia, are testimony of HCL’s commitment to the region, which contributes nearly 60 percent of the total company revenues.