Sweden Subsidised Phesgo in Both Early and Metastatic Breast Cancer as Pertuzumab Biosimilars Approach
A general subsidy in both settings is a clean result for Roche’s subcutaneous strategy, landing before pertuzumab biosimilars.
Biosimilars
EU Pharma Package Sets Nine Years’ Default Protection and Rewards Comparative Trials With a Tenth
The default gets shorter, and the route back to the maximum runs through comparative trials and filing early in Europe.
Tuznue Won Brazil Approval a Month After Its Plant Passed Anvisa Inspection, Nearly 20 Months After Filing
In Brazil the constraint on Prestige’s Herceptin biosimilar was not the dossier. It was the factory inspection.
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.
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.