The Pharma Data

DECEMBER 28, 2020

Amphastar’s newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin. Additionally, the Company sells insulin API products. ” According to IQVIA, the U.S.

Bioequivalency 52

Bioequivalency Production Sales Marketing 52

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. Cheaper options are meanwhile becoming available.

Insulin 52

Insulin Production Generic Drugs FDA Approval 52

XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. The FDA approved the drug over a decade ago in September 2009.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

Pharmaceutical Technology

DECEMBER 4, 2022

While small molecule drugs can be remade into identical generics, biologics are more complex. There are seven FDA-approved Humira biosimilars, of which Amgen’s Amjevita will be launched in January. For example, the first-to-market status was beneficial when it came to insulin biosimilars. Free Report.

Marketing 262

Marketing Pharmacy Production Branding 262

Pharmacy Checkers

MARCH 11, 2020

While the NPRM recognizes the importance to Americans of buying more affordable drugs outside the U.S., the FDA seems to defer actions that are not only permissible but encouraged under Section 804(J) to expand access to personally imported FDA-approved and foreign versions of FDA-approved drugs.

Pharmacy 41

Pharmacy Drugs FDA Approval Licensing 41