Insulin glargine biosimilars supposed to contribute 15% to total cost savings in overall biologic expenditures.
According to a 2015 study by RAND, insulin glargine biosimilars/follow-on agents were supposed to contribute 15% to total cost savings in overall biologic expenditures. This would be substantial, considering the size of the insulin marketplace, and their potential to slow increasing market shares from next-generation long-acting insulins.
But the savings may not be that quick to accrue. When Lilly introduces its version of insulin glargine (Basaglar) to the long-acting insulin market next month, what will the savings be? As a reminder, this product is not a biosimilar, according to its regulatory approval pathway, but a follow-on biologic, which means that it required more clinical trial data.
But the savings may not be that quick to accrue. When Lilly introduces its version of insulin glargine (Basaglar) to the long-acting insulin market next month, what will the savings be? As a reminder, this product is not a biosimilar, according to its regulatory approval pathway, but a follow-on biologic, which means that it required more clinical trial data. For example, Lilly conducted 2 Phase 3 studies (ELEMENT-1 and ELEMENT-2) with patients with types 1 and 2 diabetes mellitus, respectively) who had been treated prior to enrolling in the investigation. Furthermore, design and development costs of the pen-delivery device must be considered.
On this basis, one should not expect more than 15% discounts off of wholesale acquisition cost. This does not consider possible rebates and individual contracts made with CVS Health and OptumRx to prefer Basaglar and exclude Lantus® from coverage. However, it does seem reasonable that additional versions of insulin glargine will need to enter the marketplace before general discounts are commonly seen.
When might this occur? The next drug up for approval is a result of the Merck—Samsung Bioepis collaboration. On August 5, 2016, the FDA accepted their application for 351(a) approval of MK-1293. They also filed for biosimilar approval in Europe earlier this year, with the hope of receiving positive news from the EMA before the end of the year.
On November 3, 2016, Biocon and Mylan submitted its application to the European Medicines Agency (EMA) for a biosimilar to insulin glargine. Lilly had submitted its drug as a biosimilar as well to the EMA, and as a result, it is already available in the EU. There is no word as of yet when Biocon/Mylan’s 351(a) application will be submitted to the FDA. Its 500-patient phase 3 study of this product versus Lantus® in patients with type 1 diabetes was completed in June 2016. Its 600-patient phase 3 investigation in patients with type 2 diabetes was estimated to be completed in June as well. An open-label extension study of the agent is underway and will be finished in March 2017. This seems to support—assuming positive results, of course—a regulatory submission no earlier than Q4 2017.
Therefore, it may be late 2018 before 3 follow-on insulin glargine products are actively competing with Lantus® and its next-generation insulin glargine brand. By that time, discounts and rebates may mean savings of 30% or more, as the category becomes saturated, to nearly commodity levels.
FDA Approves Another Pair of Denosumab Biosimilars, Conexxence and Bomyntra
March 27th 2025The FDA approved another set of denosumab biosimilars, Conexxence/Bomyntra (denosumab-bnht), expanding treatment options for osteoporosis, bone metastases, and other bone-related conditions, amidst a flurry of similar approvals and legal settlements.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
BioRationality: How Developers Can Expand Their Monoclonal Antibody Biosimilar Portfolio
March 24th 2025Monoclonal antibodies lead biosimilar approvals because of their large market size, well-defined regulatory pathways, and technological feasibility, whereas other biologics encounter development challenges but may see increased adoption as regulatory frameworks advance.
Patients With IBD Maintain Therapy 2 Years Post Switching to Infliximab Biosimilar
March 23rd 2025People with inflammatory bowel disease (IBD) who switched to the infliximab biosimilar CT-P13 had higher treatment persistence (84% and 91%) than those new to infliximab (66% and 53%), with no new safety concerns.