MPP's Guide To Cutting Biosimilar Approval Times, Costs By Third Or More
Keytruda Biosim Could Cost 44% Less To Develop
Executive Summary
The Medicines Patent Pool has conducted a study on the impact of licensing and technology transfer on the timeline and costs of developing five biosimilars, including Merck’s Keytruda. While a licensing deal for pembrolizumab might not be a near-term possibility, the findings could help licensors, licensees and regulators increase access to medicines.
You may also be interested in...
Data Exclusivity Demand In EFTA-India Deal: Access, Licensing, Other Implications
The contentious issue of data exclusivity came to the fore during the European Free Trade Association's negotiations with India for a Free Trade Agreement. What are the arguments in support and against, including impact on compulsory and voluntary licensing?
Stelara Biosimilars In Wings, Will Proposed Red Tape Elimination Act Aid Biosimilars Push?
As Stelara biosimilars wait in the wings, proposed legislation in the US could ease the path to commercialization. The Draft Red Tape Elimination Act aims to remove a requirement for switching studies. Opposition to the bill is expected, but if passed how much will the Act move the biosimilars needle in the country? Scrip spoke to experts to gauge its likely impact.
Amid US Cough Syrup Findings, Regulators Feel India Needs To Work On Perceptions But Also Make Improvements
In wake of the furore caused by OTC cough syrups made by two small Indian companies, former and current US FDA and MHRA officials say quality-related issues are not specific to India. However, while image management needs some work, manufacturers in the country also need to make further improvements to ensure quality.