article thumbnail

California’s low-cost insulin plans receive $100m manufacturing boost

Pharmaceutical Technology

Insulin prices made the headlines again as California governor Gavin Newsom announced plans on 7 July for the state to manufacture low-cost insulin. The state plans to work directly with a contract manufacturing organization (CMO) to manufacture low-cost insulin. In-house manufacturing the norm.

Insulin 328
article thumbnail

FDA okays Mylan insulin drug as first ‘interchangeable’ biosimilar

pharmaphorum

Generic drugmaker Mylan has become the first company to secure FDA approval for a biosimilar product that is considered completely interchangeable with the reference product – namely Sanofi’s once-daily insulin Lantus.

Insulin 98
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “genericdrugs of the biopharma world.

article thumbnail

Amphastar Announces Approval for Glucagon for Injection Kit, 1mg

The Pharma Data

This further highlights Amphastar’s considerable abilities to bring complex generic drugs to the market, and more specifically, our strong peptide capabilities.” sales for Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, 1 mg, were approximately $144 million, and the overall U.S. ” According to IQVIA, the U.S.

article thumbnail

Health Canada’s proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations

Pharma in Brief

Rolling submissions, which are currently in use for COVID-19 drugs, would be extended to other drugs, such as those which address significant new and emerging infectious diseases in Canada, or which treat, prevent, or diagnose serious or severely debilitating diseases or conditions. Biologic Drugs. Labelling.

article thumbnail

Civica plans shake-up of insulin sector with low-cost biosimilars

pharmaphorum

Non-profit drugmaker Civica Rx has said it will launch biosimilars of three big-selling insulin products in the US by 2024 to help diabetic patients struggling with the cost of the drugs.

Insulin 52
article thumbnail

Insulin price caps on the horizon as Senate leader plans vote

pharmaphorum

The US Senate will vote in the coming weeks on whether to introduce a $35 cap on the monthly cost of insulin to patients that was endorsed by President Joe Biden in his 2022 State of the Union address. Assuming the bill is later passed by the Senate and signed into law by President Biden, the insulin cap would take effect beginning in 2023.

Insulin 75