Biosimilars Disease Packaging Therapies 
Drug Discovery World
MAY 1, 2023
The Commission states that, currently, there are significant gaps in addressing unmet medical needs, rare diseases and antimicrobial resistance (AMR). The EC also says that earlier availability of generic and biosimilar medicines will be facilitated, and market authorisation procedures simplified.
The Pharma Data
APRIL 4, 2023
The approval includes all indications covered by the reference medicine*: rheumatic diseases, Crohn’s disease, ulcerative colitis, plaque psoriasis, uveitis and hidradenitis suppurativa. 1 “Living with a chronic disease can take a significant toll on a patient’s quality of life.
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Drug Discovery World
MARCH 29, 2023
UMNs have been defined in the context of the draft as diseases where there’s a lack of good treatments, and which have a high burden 3. For rare disease drugs, a variable RDP period of five, nine, or ten years, depending on the novelty of the drug. He pointed out that Europe was the first region to approve biosimilars.
The Pharma Data
FEBRUARY 25, 2022
Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An
Agency IQ
JULY 8, 2024
12/29/2023 FDORA, Section 3202 Rare Diseases: GAO to release a report to Congress assessing the policies, practices, and programs of the FDA with respect to the review of applications for approval of drugs and biologics intended to treat rare disease, with a focus on the effectiveness of FDA’s policies and challenges encountered by sponsors.
The Pharma Data
MAY 2, 2022
Data from the completed studies of zuranolone in the LANDSCAPE and NEST clinical development programs, including data from the ongoing open-label SHORELINE Study in MDD, as well as data from the completed clinical pharmacology studies, will comprise the full submission package. Food & Drug Administration.
Agency IQ
MAY 3, 2024
Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)
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