FDA Law Blog: Biosimilars

JUNE 16, 2023

We expect the Minnesota law to face Commerce Clause, vagueness, and possibly other constitutional challenges, similar to those brought against a generic price gouging prohibition in Maryland that was struck down by the Fourth Circuit in 2018 (see our post here ).

Drug Pricing 45

Drug Pricing Biosimilars Dosage Documentation 45

FDA Law Blog: Biosimilars

JULY 10, 2023

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 For labeling documents and the 510(k) summary, FDA often requests both clean and redlined versions. Average Number of Industry Days to MDUFA IV Decision 54.69 Average Number of Total Days to MDUFA IV Decision 127.31

Documentation 75

Documentation Packaging Communication Labelling 75

PharmaShots

MAY 3, 2023

Our team at PharmaShots has summarized 15 key events of the biosimilar space of April 2023 1. Celltrion Reports 24 Week P-III Trial Results of CT-P42 (biosimilar, aflibercept) for Wet Age-Related Macular Degeneration and Diabetic Macular Edema Date- April 03, 2023 Product: CT-P42 (biosimilar, aflibercept) The company highlighted the 24wk.

Biosimilars 56

Biosimilars Labelling Diabetes 56

PharmaShots

APRIL 13, 2023

The company experienced significant challenges with patent expiration in 2018 Pfizer recorded substantial advancements in 2016 with the approval of five drugs and $52.8 as compared to 2018 Novartis recorded sales of $52B, Sandoz division contributed 19% of the group's total net sales. The consumer health business growth was 6.1%

Biosimilars 40

Biosimilars Vaccines Pharmaceutical Companies Pharmaceutical Companies 40

PharmaShots

APRIL 3, 2023

multiple indications such as RA & Crohn's disease Hyrimoz was originally approved by the EC in 2018 with a concentration of 50mg/mL. multiple indications such as RA & Crohn's disease Hyrimoz was originally approved by the EC in 2018 with a concentration of 50mg/mL. The authorization incl. The authorization incl.

Biosimilars 40

Biosimilars Diabetes Compounding Hospitals 40

FDA Law Blog: Biosimilars

JANUARY 13, 2025

Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act This final guidance replaces previous draft and final guidance documents on food allergen labeling that FDA issued in November 2022, which we discussed in a previous post.

Documentation 105

Documentation Labelling 105

RX Note

FEBRUARY 23, 2023

Terazosin - Off-label use in ureteral stone(s) expulsion Topical Corticosteroids - Apply thinly on the skin using fingertip unit. Statins - Not all statins need to be taken at night.

HIV Treatment and Prevention Agents 58

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

FDA Law Blog: Biosimilars

NOVEMBER 20, 2024

of ISO 10993-1:2018, but is extremely burdensome and not referenced in the related ISO 10993-18. FDA’s suggestion to test the maximum reprocessing cycles for reusable devices is aligned with the recommendations in clause 4.8

Compounding 59

Compounding Labelling 59

pharmaphorum

FEBRUARY 5, 2021

The FDA did go on to add warning labels in the following years and eventually decided to require a class-wide monitoring programme, with training for doctors. Immediately before she took her job at the FDA, Abernethy worked for the electronic health records firm Flatiron Health, which was bought by Roche in 2018. Dr Janet Woodcock.

Vaccines 119

Vaccines Biosimilars Labelling 119