Korea Repriced 36 Fewer Items This Year and Took Out the Same ₩33.9 Billion
Thirty-six fewer items produced the same saving. Nothing about efficacy changed. The medicines that grew paid for it.
Biosimilars
Biocon Makes It, a Consultancy Holds the Licence, and Sandoz Sells It
Three parties, three functions, and Biocon holds only the middle one. Treat the caretaker MAH structure as the Japanese default, not the exception.
In Ustekinumab Biosimilars, Approval Stopped Being the Hard Part
A biosimilar licence used to be the scarce asset. In ustekinumab it is the entry ticket, and the returns go to whoever solves supply and device.
The EPO Revoked BMS’s 480mg Opdivo Patent Because the Trial Behind It Dosed by Weight
BMS claimed a 480mg flat dose. The only clinical example in its filed application dosed by weight. The EPO revoked the patent on added matter.
Dr. Reddy’s Developed, Made and Filed the Rituximab. Fresenius Only Sells It.
Fresenius describes an end to end biopharma business. Dr. Reddy’s developed, made and filed this rituximab. Fresenius is only the channel.
The Biosimilar Was Too Cheap to Sell. So the Price Went Up Fourfold.
Byooviz relaunched in the US at an average sales price of $1,190, roughly four times its previous level and above the originator it references.
Accord’s Denosumab Biosimilars Launch With Cigna Preferred Status Already Secured
Accord made two interchangeable denosumab biosimilars commercially available with Cigna preferred status already secured on the pharmacy benefit since 1 July.
Spain rewrites its drug-pricing rulebook, and the price of a generic will now fall as it sells more
Spain’s new draft Medicines Law will cut the price of generics and biosimilars automatically as their market share grows, replacing a system where prices froze after one initial discount.
Reimbursement Series: CMS and Europe Reimbursement Pathway Accelerates Innovation
In a transformative week for market access, the CMS and Europe reimbursement pathway expansion delivered several pivotal coverage and pricing decisions reshaping patient access across cardiovascular, hepatic, and oncology therapies. From CMS’s national determinations on breakthrough devices to European HTA approvals in rare disease and cancer, these developments underscore a growing transatlantic alignment between regulators … Read more
FDA’s BsUFA III Framework: What It Means for Biosimilar Sponsors
FDA defines biosimilar PAS & CBE under BsUFA III