Diabetes

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.

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.

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.

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.

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.

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.

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

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.

Access to new treatment options for ophthalmic conditions and diabetes is on the rise with the launch of Sandoz’ generic ocular hypertension medication, a new deal to bring a ranibizumab biosimilar to the Middle East, and the initiation of a trial for an insulin glargine biosimilar.

A real-world analysis found similar safety and efficacy profiles between a biosimilar ranibizumab (Razumab) and the reference product (Lucentis, Accentrix) in Indian patients with diabetic macular edema.

The Committee for Medicinal Products for Human Use (CHMP) recommended 2 insulin biosimilars for marketing authorization in Europe.

Civica Rx will collaborate with companies to manufacture and distribute 3 insulin biosimilars and will offer them at an affordable price to uninsured and underinsured patients.

The year 2021 proved to be big for biosimilars, with 4 approvals and increased competition, signaling that FDA is shifting some of their focus from the pandemic back to the growing industry.

The year 2022 “is set to be a turning point” in the United States, as biosimilars are on their way to delivering $133 billion in aggregate savings by 2025, according to Cardinal Health's “2022 Biosimilars Report: The U.S. Journey and Path Ahead.”

The province is the latest jurisdiction to adopt a program that will require patients to switch away from expensive reference biologics to select biosimilars for certain conditions.

US biosimilar uptake faces several barriers, including misconceptions regarding biosimilar efficacy and a misalignment of prescription incentives between payers, providers, and patients, panelists discussed.

Insulin costs have increased dramatically in recent years, and the study authors note that high costs for many patients result in nonadherence or insulin rationing, leading to diabetic complications and even death.

The International Generic and Biosimilar Medicines Association has appointed a veteran member, Vivian Frittelli, MBA, ACIS, to take over as chair.

Ford Motor saved $5 million by switching patients to 5 biosimilars, and other manufacturers and employers in Michigan have achieved good results with switching programs, the Economic Alliance of Michigan reports.

In a recent paper, Sarfaraz K. Niazi, PhD summarizes some of his central ideas on the relevance of FDA biosimilar testing standards.

In India, an emphasis on outdated biosimilar testing has restricted market entry of these products and discouraged manufacturers, patient advocates contend.

Savings from adalimumab biosimilars, which won't enter the US market until 2023, account for a significant share of the total, investigators said.

Biosimilars have produced more than $20 billion of savings in Europe, but more use of these agents is needed.

The top legal stories in biosimilars over the past year concerned etanercept and adalimumab biosimilars and access to insulin.

With an FDA approval for a second insulin glargine biosimilar, the stage is set for stronger competition in 2022 with potential improved access and savings for patients.

Lannett hopes to initiate a pivotal trial of its insulin glargine biosimilar candidate, in anticipation of a launch in 2024.

In Canada, a new jurisdiction inaugurates mandatory switching to biosimilars.

From the approval of the first insulin glargine biosimilar (Semglee) to the potential for extreme biosimilar competition in the adalimumab market, 2021's regulatory stories were popular with readers.

The year 2021 brought several firsts in biosimilars and set the stage for expansion across therapeutic areas including diabetes and ophthalmology.

Investigators said more evidence would help to convince clinicians of the safety of switching between biosimilar products.