Roche’s Lucentis saw US sales roughly halve in 2023, from about $1.06 bn to $512m, but not because of the biosimilars that had just entered. So who did the damage? Therapeutic Thursday. Read it here... capsul.news/therapeutic-thur…

Humira biosimilars sat at low single-digit share for a year, until CVS Caremark pulled Humira from major commercial formularies in April 2024. Erosion speed is a payer decision. Stelara’s path was different. Therapeutic Thursday. Read it here... capsul.news/therapeutic-thur…

Pembrolizumab launched in 2014 with a single accelerated melanoma approval. Keytruda now carries 40-plus US indications and brought in $31.7 bn in 2025. Static scenarios can’t capture that path dependence. What else moves the ground? Therapeutic Thursday. Read it here... capsul.news/therapeutic-thur…

The hard part of a biosimilar isn’t making it. It’s deciding which molecule to copy, a choice made eight to ten years before launch. What happens when the industry treats two separate questions as one? Therapeutic Thursday. Read it here... capsul.news/therapeutic-thur…

MHRA’s proposed fee waiver scheme would cover the full fee for new active substance applications, scientific advice and clinical trials, with a £2m annual cap and a requirement for a substantive UK presence. Who is it meant for? Watchdog Wednesday. Read it here... capsul.news/watchdog-wednesd…

MHRA’s new active substance guarantee covers a first assessment within 90 days, not an approval. A missed deadline returns only part of the targeted fee increase. So what is the rebate, really? Watchdog Wednesday. Read it here... capsul.news/watchdog-wednesd…

Most MHRA statutory fees (180 of them) would rise 8.93%. Another 25 “higher-value” fees would climb about 27%. Which figure belongs in your UK budget? Watchdog Wednesday. Read it here... capsul.news/watchdog-wednesd…

MHRA’s fee proposal offers sponsors a menu: scientific advice in half the time at double the price, or a priority slot for new active substance reviews for an extra £100,000. What is your time worth? Watchdog Wednesday. Read it here... capsul.news/watchdog-wednesd…

Amgen’s Imdelltra: first-line maintenance SCLC with Imfinzi, topline met OS, PFS and ORR. Monitoring window of 1–2 hours vs the label’s 22–24. Only ~40% of patients reach second-line. What could that change? Trial Tuesday. Read it here... capsul.news/trial-tuesday-ey…

Moderna/Merck’s individualized mRNA vaccine, built from a patient’s own tumor and coding up to 34 neoantigens, showed significant RFS and DMFS gains vs Keytruda alone in resected melanoma. Why does the size of the benefit matter? Trial Tuesday. Read it here... capsul.news/trial-tuesday-ey…