Generic Drugs, Insulin and Marketing - Clinical Research Informer

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

Pharmaceutical Technology

JULY 15, 2022

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

Insulin Manufacturing Contract Manufacturing Production

FDA okays Mylan insulin drug as first ‘interchangeable’ biosimilar

pharmaphorum

JULY 29, 2021

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

Insulin Drugs Production Generic Drugs

Insulin price caps on the horizon as Senate leader plans vote

pharmaphorum

MARCH 23, 2022

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

Insulin Generic Drugs Production FDA Approval

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

pharmaphorum

MARCH 3, 2022

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

Insulin Production Generic Drugs FDA Approval

FDA approves first interchangeable biosimilar insulin product for treatment of diabetes

The Pharma Data

JULY 29, 2021

Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Biosimilars marketed in the U.S. for the treatment of diabetes.

Insulin

Insulin Production FDA Approval Generic Drugs

A Short-Term Gain for a Long-Term Loss? The Build Back Better Act’s Medicare Drug Price Negotiation Program Ignores Hatch-Waxman/BPCIA Realities. and that May Mean Big Bad Business for Generic Drug/Biosimilar Manufacturers

FDA Law Blog

NOVEMBER 16, 2021

139001 lays out a process by which the Secretary would: Identify “negotiation-eligible drugs” from among qualifying single-source drugs that are among the top 50 with the highest Part D spending, the top 50 with the highest Part B spending, and insulins. It means less – or no – generic/biosimilar competition.

Generic Drugs

Generic Drugs Manufacturing Drugs Licensing

Humira biosimilars set the stage for long-awaited 2023 US launches

Pharmaceutical Technology

DECEMBER 4, 2022

Starting in January, multiple biosimilars of AbbVie’s blockbuster drug Humira are set to flood the US pharmaceutical market. The arrival of Humira biosimilars is expected to provide cost-effective alternatives to the anti-tumor necrosis factor (TNF) biologic, but their eventual position on the market remains to be seen.

Marketing

Marketing Pharmacy Production Branding

Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

FEBRUARY 8, 2021

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 “generic” drugs of the biopharma world.

Production

Production Insulin Branding Generic Drugs

Amazon’s Pharmacy Doesn’t Break Big Pharma’s Hold of America’s Neck

Pharmacy Checkers

NOVEMBER 19, 2020

Not only do drug manufacturers have patents: they have special international trade protections where companies cannot import these same drugs from foreign wholesalers who charge much lower prices in Canada, not to mention the even lower prices in the UK and European Union countries – unless the drug manufacturers do the importing or authorize it.

Pharmacy

Pharmacy Insulin Branding Generic Drugs

Amphastar Announces Approval for Glucagon for Injection Kit, 1mg

The Pharma Data

DECEMBER 28, 2020

Using a dedicated process and sophisticated characterization technology, we demonstrated to the Agency that our highly purified synthetic peptide product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), which is an rDNA product. Additionally, the Company sells insulin API products.

Bioequivalency

Bioequivalency Production Sales Marketing

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

Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Generic drugs and biosimilars are not eligible for this application pathway. Biologic Drugs.

Regulation

Regulation Drugs Manufacturing Production

Recon: Moderna lifts guidance on COVID vaccine sales; US backing of patent waiver causes stir

The Pharma Data

MAY 6, 2021

Nevro raises outlook as neuromodulation market recovers from COVID-19 crisis ( MedtechDive ). Lilly inks smart insulin pen deals with Roche, Dexcom and more ( Fierce ). million to resolve claims it paid drug kickbacks through charity ( STAT ). Government, Regulatory & Legal.

Sales

Sales Vaccination Vaccine Gene Therapy

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. 2022 Revenue: Pfizer reported an annual revenue of $100.33 Pfizer Inc.

Sales

Sales Manufacturing FDA Approval Life Science

Clinical Research Informer

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

FDA okays Mylan insulin drug as first ‘interchangeable’ biosimilar

Trending Sources

Insulin price caps on the horizon as Senate leader plans vote

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

FDA approves first interchangeable biosimilar insulin product for treatment of diabetes

A Short-Term Gain for a Long-Term Loss? The Build Back Better Act’s Medicare Drug Price Negotiation Program Ignores Hatch-Waxman/BPCIA Realities. and that May Mean Big Bad Business for Generic Drug/Biosimilar Manufacturers

Humira biosimilars set the stage for long-awaited 2023 US launches

Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

Amazon’s Pharmacy Doesn’t Break Big Pharma’s Hold of America’s Neck

Amphastar Announces Approval for Glucagon for Injection Kit, 1mg

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

Recon: Moderna lifts guidance on COVID vaccine sales; US backing of patent waiver causes stir

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

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