The Pharma Data

JUNE 6, 2025

Biosimilars and Generics : Where cost competition necessitates strategic brand differentiation and efficient coverage. OTC and Consumer Health Products : Brands in this segment benefit from lean, geographically dispersed sales forces that focus on brand visibility and pharmacy-level engagement.

Pharmaceutical Companies

BioPharma Drive: Drug Pricing

JULY 22, 2025

The Food and Drug Administration on Tuesday rejected a melanoma drug developed by Replimune. Ben Fidler Cancer drug developer iTeos Therapeutics will sell itself to Concentra Biosciences as part of a plan to wind down and disburse cash to its shareholders. Omega has raised more than $2.5

FDA

BioPharma Drive: Drug Pricing

JULY 21, 2025

After the fierce competition between Humira (adalimumab) biosimilars, manufacturers are keeping a close eye on adoption dynamics for biosimilars of Johnson & Johnson’s autoimmune drug, Stelara (ustekinumab). What is the impact of vertical integration, the IRA and other factors on biosimilar adoption?

Biosimilars

Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

Biosimilars

Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area. If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

FDA

Agency IQ

OCTOBER 27, 2023

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B.

FDA

Agency IQ

SEPTEMBER 29, 2023

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B.

FDA