October 11th 2024
Adalimumab biosimilars have seen a significant increase in market share, from 2% in early 2024 to 22%, as payers and pharmacy benefit managers begin to prioritize these biosimilars over the reference product, Humira.
FDA Releases Draft Guidance on Insulin Biosimilars, Interchangeable Insulins
November 25th 2019The FDA today released draft guidance for industry on clinical immunogenicity considerations for biosimilar insulins and interchangeable insulins. The guidance document provides recommendations as to whether—and when—comparative clinical immunogenicity studies will be needed to support an application to the FDA for insulin products under the biosimilar approval pathway.
Novo Nordisk Plans Authorized Generic Insulins for Early 2020
September 12th 2019Insulin maker Novo Nordisk has announced that, in January of 2020, it will launch authorized generics of its NovoLog (insulin aspart) and NovoLog Mix (insulin aspart protamine and insulin aspart) products. Notably, the authorized generics will become available before the March 2020 transition of insulins to regulation as biologics and biosimilars rather than drugs and generics.
Women More Likely Than Men to Ration Diabetes Meds Due to Cost, CDC Says
August 27th 2019Women are more likely than men not to take their diabetes medication as prescribed in an effort to control prescription drug costs, as are adults under age 65, according to a report published this month by the Centers for Disease Control and Prevention (CDC).
How Prepared Is the United States for the Transition of Insulins to Regulation as Biologics?
August 20th 2019While drug makers who sell insulin in the United States have had the past decade to prepare for the transition, stakeholders within the diabetes community must grapple with the potential impacts that this regulatory change could have.
Patients Say They Are Ready for Cost-Saving Biosimilar Insulin
August 10th 2019Winnie Tiedemann, 73, of New Jersey lives with her son and his 5 children. Tiedemann was diagnosed with diabetes at age 25 and has been insulin-dependent for the past 20 or so years. Her out of pocket costs for insulin? Around $3600 a year.
Study Finds Rituximab Noninferior to Cyclosporine for Membranous Nephropathy
July 4th 2019A study published in The New England Journal of Medicine examining rituximab in membranous nephropathy found that it is noninferior to cyclosporine in inducing proteinuria remission at 12 months and is superior to maintaining long-term remission up to 24 months in patients at high risk for progressive disease.
At ADA, Sanofi Reveals Data on Proposed Insulin Aspart Biosimilar, SAR341402
June 10th 2019Insulin maker Sanofi is currently developing a proposed biosimilar of insulin aspart (NovoLog), made by Novo Nordisk. In 3 late-breaking poster presentations at the American Diabetes Association (ADA) 79th Scientific Sessions, held June 7-11, 2019, in San Francisco, California, researchers presented data on the biosimilar, SAR341402.
Amid Outcry Over High Costs, Eli Lilly Launches Lower-Priced Insulin Lispro
May 23rd 2019Eli Lilly and Company announced this week that it has made a lower-cost insulin lispro injection available in pharmacies. The company said that the authorized version carries a list price ($137.35 per vial and $265.20 for a package of 5 pens) that is 50% lower than that of the brand-name Humalog injection.
FDA Hears From Stakeholders About Insulin Transition to Biologic Pathway in 2020
May 14th 2019Set against a backdrop of rising concern about the cost of insulin, the FDA held a hearing about biosimilar insulins Monday, 10 months before the products transition in March 2020 from the Food Drug and Cosmetic Act to biologics under the Public Health Service Act.
Chinese Study Finds Patients Taking Reference Insulin Glargine Had Better Glycemic Control
May 2nd 2019While a study in healthy volunteers demonstrated bioequivalence of the 2 insulin products, to date, few direct comparisons of the biosimilar and the innovator have been available. A new study compared the efficacy and safety of treatment with each of the products in a retrospective analysis of hospitalized patients with type 2 diabetes and found that the reference insulin provided better fasting glycemic control than the biosimilar.
Eli Lilly Launching Lower-Priced Authorized Generic of Its Insulin Lispro
March 4th 2019Eli Lilly and Company said Monday it is introducing a lower-priced authorized generic of its insulin lispro injection (Humalog) in the United States. The generic will have a list price 50% lower than the current Humalog list price.
Pfenex and Alvogen to Partner on Teriparatide Follow-on
March 1st 2019Pfenex and Alvogen announced this week that they have entered into agreements to develop and commercialize PF708, a follow-on teriparatide product referencing Forteo, for the treatment of osteoporosis, in the European Union, some countries in the Middle East and North Africa, and other territories.
Eli Lilly Hints That It May Pursue "Branded Biosimilars" of Its Own Products
February 18th 2019The comment period has recently closed for the FDA’s proposed approach to the transition of insulins and other products that have historically been regulated as drugs and follow-ons to regulation as biologics and biosimilars, and among the comments from stakeholders is a suggestion that one drug maker may be interested in selling biosimilars of its own products.
High Costs Drive 1 in 4 Patients With Diabetes to Use Too Little Insulin
December 27th 2018Despite the fact that the World Health Organization classifies insulin as an essential medicine that should be available at all times at a price that patients can afford, US insulin prices have continued to climb in recent years.
Congressional Report Makes Recommendations to Decrease Insulin Prices, Includes Follow-on Products
November 3rd 2018In a recently published bipartisan report, representatives Diana DeGette, D-Colorado, and Tom Reed, R-New York, co-chairs of the Congressional Diabetes Caucus, released findings from a year-long inquiry into the sources of ever-increasing insulin prices.
Study: Biosimilars Could Drastically Reduce the Cost of Insulin
October 5th 2018“Comparison of estimated prices with recent government procurement prices suggests that robust competition in the human insulin and insulin analogue market would lead to sizeable savings in most countries and that current manufacturers could set significantly lower prices while still making a profit,” write the study’s authors.
Follow-On Insulin Glargine Shows Similar Safety, Efficacy to Lantus in T1D
August 14th 2018While US patients with diabetes await the launch of the follow-on, which is expected to offer a welcome cost-savings, newly published data from a 52-week clinical trial in patients with type 1 diabetes (T1D) underscore its similar safety and efficacy to the reference insulin glargine.