FDA Law Blog: Biosimilars

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year. covered insulin product or vaccine).

Compliance 104

Compliance Drugs Pharmacy Licensing 104

The Pharma Data

JULY 29, 2021

100% Efficacy Observed in Phase 2b Trial of RSV Adult Vaccine Candidate; Provides New Data Updates on its COVID-19 Vaccine Booster and Oral COVID-19 Antiviral Programs As Part of a Broader Review of 8 Potentially First-in-Class Compounds NEW YORK, NY, Wednesday, July 28, 2021 – Pfizer Inc. Second-Quarter 2021 Revenues of $19.0

Biosimilars 52

Biosimilars Vaccine Production International 52

Agency IQ

AUGUST 2, 2024

All clinical trials still ongoing must transition to the Clinical Trials Regulation by January 31, 2025 to ensure continuity. Positive August 2024 Eurneffy (epinephrine) Ars Pharmaceuticals Irl Limited Positive August 2024 MResvia (Respiratory Syncytial Virus mRNA vaccine) Moderna Biotech Spain S.L.

Regulations 40

Regulations Clinical Trials Production Trials 40

Agency IQ

DECEMBER 1, 2023

If all changes are accepted, the date of application is set to be January 1, 2025. Positive *Biosimilar **Generic Notable comment periods closing in December Below are various deadlines regarding E.U. The changes to the EMA’s Fee Regulation (Regulation (EC) No 297/95) could be adopted during this month’s planned plenary meeting.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Agency IQ

JULY 8, 2024

Positive August 2024 Eurneffy (epinephrine) Ars Pharmaceuticals Irl Limited Positive August 2024 MResvia (Respiratory Syncytial Virus mRNA vaccine) Moderna Biotech Spain S.L. Positive August 2024 Enzalutamide Viatris (enzalutamide)** Viatris Limited Positive August 2024 Nilotinib Accord (nilotinib)** Accord Healthcare S.L.U.

Regulations 40

Regulations Pharmaceuticals Production Vaccine 40

Agency IQ

MAY 31, 2024

There will also be a number of noteworthy conferences taking place this month pertaining to the vaccine and medical technology industries. Many of these webinars and trainings sessions are geared towards medical devices and in vitro diagnostics (IVDs). s Medicines and Healthcare products Regulatory Agency (MHRA).

Regulations 40

Regulations Production Compliance Pharmaceuticals 40

Agency IQ

MARCH 29, 2024

Title Type Deadline Guideline on clinical investigation of medicinal products in the treatment of depression [EMA] Scientific guideline 3/31/2024 Concept paper on the establishment of a Guideline on the development and manufacture of human medicinal products specifically designed for phage therapy [EMA] Concept paper 3/31/2024 Pharmeuropa 36.1

Regulations 40

Regulations Production Clinical Trials Biosimilars 40