Diabetes

President Trump signed 4 executive orders that would lower prices of prescriptions medications including insulin products and cancer medicines.

For Biocon, overall revenues were up during the fiscal quarter that just ended, driven by strong revenues in its biosimilars and generics operations.

In a deal with Voluntis, Biocon Biologics aims to extend the appeal of its insulin products by offering a digital titration device for self-management of insulin dosage.

With insulin originator product patents expiring, drug companies are seeking to extend exclusivities via patents on injectors and other delivery products.

Now is the time for the FDA to lead again in revising the biosimilar development guidance by eliminating all animal toxicology studies, and replacing them with larger-species pharmacokinetic (PK) studies, allowing the conduct of human PK studies using novel clinical protocols to combine the PK/pharmacodynamic/immunogenicity testing in a single study, and, where possible, avoid these studies if an in-silico approach can provide the confidence of pharmacologic similarity.

Biocon is planning to list its biosimilar entity, Biocon Biologics, on the capital markets in the next few years. Although this move will allow the entity to expand on current projects, it also raises questions about whether it will be successful.

There is much inconsistency in the way physicians transition patients from insulin degludec to insulin glargine upon hospital admission, leading to higher risk especially for patients with type 1 diabetes, according to a study presented at the American Diabetes Association 80th Scientific Sessions online conference.

Eli Lilly gets FDA approval for a new formulation of insulin lispro and offers it at the out-of-pocket cap of $35 for a monthly supply for patients with or without insurance.

Lannett’s insulin glargine biosimilar candidate will break new ground as it moves through the 351(k) review pathway, according to Ha Kung Wong, an intellectual property law attorney with Venable of New York.

In gaining FDA approval, the insulin glargine product Semglee receives automatic status as a biologic under the Biologics Price Competition and Innovation Act (BPCIA), although it was approved as a 505(b)(2) product under the Food Drug and Cosmetic Act. Semglee becomes the first insulin glargine under the 351(a) pathway.

Investigators said the English health care system has realized only a sliver of the potential savings potential from biosimilar insulin glargine and that uptake is widely uneven across health care centers.

Longtime generics maker Lannett, of Philadelphia, Pennsylvania, said an FDA meeting this week was positive for its pending insulin glargine biosimilar application.

CMS announced that its Part D Senior Savings Model designed to cut insulin costs for struggling Medicare beneficiaries is attracting broad insurer participation, indicating high potential for success.

Swedish researchers analyzing more than 10 years of data found that Omnitrope (biosimilar recombinant human growth hormone) is safe and effective in treating adult and pediatric patients with growth hormone deficiencies.

Biocon said a subsidiary’s manufacturing centers in Bengaluru, India, were cleared by European Union authorities for biosimilar production.

A bill designed to provide assistance to patients who cannot afford their insulin was signed into law by Minnesota Governor Tim Walz.

A commentary in The Lancet suggests that the new biological pathway for insulin product approval, established in March, will be insufficient to address issues insulin prices and biosimilar uptake.

After noting the stories of individuals with diabetes dying due to their inability to afford insulin, the Minnesota House has passed an emergency insulin bill that is expected to move rapidly through the Senate to the governor’s desk.

Russia has rebuilt its pharmaceutical industry following the demise of the former Soviet-led government, and emerging companies such as Geropharm are looking for markets abroad.

Longtime generics manufacturer Lannett is moving an insulin glargine biosimilar development plan forward and announced an upcoming meeting with the FDA. The agent would compete with the reference product Lantus.

After a number of issues raised by the FDA about plant quality, Biocon has gotten clearance for its Malaysia insulin plant and now awaits FDA marketing authorization for Semglee, its insulin glargine agent.

Two doctors call for interchangeability requirements for biologics to be waived for insulin products under the new regulatory pathway under the Biologics Price Competition and Innovation Act (BPCIA) of 2009.

As regulators work to increase competition and lower costs in the insulin market, CMS has released a new Medicare model intended to lower co-pays for insulin products to a maximum of $35.

Although biosimilar insulins are available in Europe, there are none in the United States currently, although that is slated to change.

The Center for Biosimilars® recaps the top stories for the week of February 24, 2020.

This is the third Form 483 Biocon has received for the insulin plant in 3 years.

The Center for Biosimilars® recaps the top stories for the week of February 17, 2020.

Which Medicaid plans benefit the most from the current drug rebate structure and are incentivized to prescribe branded prescriptions? Researchers used the issue of follow-on insulin glargine as well as glatiramer acetate to find out.

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.

The Center for Biosimilars® recaps the top stories for the week of January 6.