Diabetes

In the first edition of Samsung Bioepis’ Biosimilar Market Report, the company outlined the current state of the US biosimilars market and how increasing adoption has had an impact on pricing changes for biosimilars and their reference products.

Two US senators introduced a bipartisan bill to extend the $35 out-of-pocket cap for insulin products, established by the Inflation Reduction Act for Medicare plans, to the commercial sector.

STADA Arzneimittel and Xbrane Biopharma announced the launch of Ximluci, a ranibizumab biosimilar referencing Lucentis approved to treat ophthalmic conditions, across the European Union.

Eli Lilly and Company has launched its insulin glargine biosimilar, Rezvoglar (insulin glargine-aglr), on the US market, making it the second interchangeable insulin biosimilar to become commercially available to American patients with diabetes.

Yukon, 1 of 3 Canadian territories, announced that it will implement a biosimilars switching policy, following Newfoundland and Labrador’s announcement to move forward with a similar policy earlier this week.

Newfoundland and Labrador is the latest Canadian province to implement a biosimilar switching policy, following in the footsteps of Ontario and 7 other jurisdictions.

As Eli Lilly and Company announces that it will slash prices for its insulin products and cap out-of-pocket costs for insulin, the company shared that it will launch its interchangeable insulin biosimilar, Rezvoglar, at a 78% discount to the originator (Lantus).

IQVIA’s Global Use of Medicines Report for 2023 has revealed increased uptake of biosimilars around the world and predicted that biosimilars could generate nearly $300 billion in savings by 2027.

A new report from HHS has revealed that if the Inflation Reduction Act (IRA) had been implemented in 2020, Medicare Part D beneficiaries could have saved a total of $734 million, averaging out to about $500 per member.

Coherus Biosciences has acquired an aflibercept biosimilar; the FDA has sent Biocon Biologics a complete response letter (CRL) regarding its insulin biosimilar; Lannett provides an update on the development of its insulin glargine and insulin aspart biosimilars.

The “biosimilar-like” insulin glargine Basaglar was not less expensive for patients than the reference product, Lantus, concluded the authors of a retrospective analysis of commercial pharmacy claims and pharmacy co-payment offsets.

A phase 1 study in China found that pharmacokinetics, safety, and immunogenicity were similar between the liraglutide biosimilar RD12014 and the reference product (Victoza) in healthy male participants.

The third in a series of clinical studies evaluating pharmacokinetics (PK) and pharmacodynamics (PD) of Biocon’s recombinant human insulins compared to their reference products, found PK and PD equivalence between the biosimilar insulin-70/30 and Humulin-70/30.

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.

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.