Follow-on biologics, reference-product erosion, payer switching, launch sequencing, and specialty-channel uptake.
Six FDA-approved biosimilars now compete with Eylea (aflibercept) in ophthalmology, two with interchangeable designation. This reference-product dossier maps every...
Six FDA-approved biosimilars now compete with Herceptin (trastuzumab) in oncology. This reference-product dossier maps every approved product, payer formulary...
Ten FDA-approved biosimilars now compete with Humira (adalimumab). This reference-product dossier maps every approved product, interchangeability status, payer adoption,...
Humira (adalimumab) was once the world's best-selling drug, but its access landscape has transformed. With ten biosimilars now FDA-approved and all three major PBMs...
Rinvoq (upadacitinib) and Humira (adalimumab) represent two fundamentally different approaches to treating rheumatoid arthritis, psoriatic arthritis, and other...
Skyrizi (risankizumab) and Stelara (ustekinumab) are both IL-23 pathway inhibitors used in plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis...
Stelara (ustekinumab) is an IL-12/23 inhibitor approved for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. With nine biosimilars now...
Interchangeability is a real FDA designation, but it is not a commercial launch plan. Here is what the Purple Book status does, what state substitution controls, and...
Orange Book and Purple Book answer different regulatory questions. Mixing them up creates bad generic, biosimilar, exclusivity, and substitution assumptions.