Diabetes

Biosimilar Business Recap: Progress for Insulin in Europe, Canada; Biocon Biologics' Viatris Acquisition Completed

November 30th 2022

By Skylar Jeremias

Capstone has announced that its human insulin biosimilar received positive opinions from the European Medicines Agency and Health Canada, signaling approvals may be on the horizon, and the acquisition of Viatris’ biosimilars portfolio by Biocon Biologics is officially complete.

Rezvoglar Becomes Second Interchangeable Insulin Biosimilar

November 23rd 2022

By Skylar Jeremias

Article

The FDA has granted Eli Lilly’s long-acting insulin glargine biosimilar, Rezvoglar, an interchangeability designation, making it the second interchangeable insulin biosimilar in the United States.

IQVIA: Semglee Experience Can Help Predict Adalimumab Biosimilar Adoption

November 3rd 2022

By Skylar Jeremias

Article

A report from IQVIA recapped the US experience with Semglee, an insulin glargine biosimilar that has versions with and without an interchangeability designation, to help predict the adoption patterns of adalimumab biosimilars when they enter the market in 2023.

Biosimilar Insulin Lispro Shows Similar PK and PD Parameters to Humalog

September 17th 2022

By Skylar Jeremias

Article

A phase 1 study in Japan found similar pharmacokinetic (PK) and glucose pharmacodynamic (PD) parameters between the biosimilar SAR342434 (SAR-Lis, Sanofi) and the Japan-reference insulin lispro (Humalog) in healthy male participants.

$35 Insulin Cap for Private Sector Blocked From Budget Reconciliation Bill

August 8th 2022

By Skylar Jeremias

Article

While efforts to cap monthly insulin costs for Medicare patients at $35 survived a budget reconciliation bill in the Senate, Republicans blocked the measure from extending to the private sector.

One Aflibercept Trial Begins; Another Insulin Recall

July 7th 2022

By Skylar Jeremias

Article

As Alvotech announced that dosing of patients with its aflibercept biosimilar candidate has begun, Viatris announces its third recall for a batch of its insulin glargine biosimilar over missing labels.

Ryan Haumschild, PharmD, Advises Practices, Health Systems to Prep for Interchangeable Biosimilars

June 5th 2022

By Skylar Jeremias

Video

Ryan Haumschild, PharmD, MS, MBA, from Emory Healthcare and Winship Cancer Institute, gives an overview of what practices and health systems need to prepare for as more interchangeable biosimilars enter the US market.

Eye on Pharma: Similis Bio Launch, Biocon Biologics Sets Sights on Malaysian Biosimilar Market

May 19th 2022

By Skylar Jeremias

Article

New biosimilars are on the way, as JSR Life Sciences launches its business division (Similis Bio) that will improve efficiency and costs related to biosimilar development and Biocon Biologics signs a contract for commercialization in Malaysia.

Teva’s Lucentis Biosimilar Gains UK Approval

May 17th 2022

By Skylar Jeremias

Article

The United Kingdom has approved Teva Pharmaceutical’s biosimilar (Ongavia) that references Lucentis (ranibizumab) for the treatment of several ophthalmic conditions.

Biosimilars Check-in: Label Error Led to Insulin Biosimilar Recall, Samsung Bioepis Acquisition Completed

April 21st 2022

By Skylar Jeremias

Article

Patients and other stakeholders received some biosimilar news, with a small recall for Mylan’s unbranded insulin glargine biosimilar and the completed full acquisition of Samsung Bioepis into Samsung Biologics.