Brazilian Regulator Consults On Improving Rules For Registering Biosimilars
Executive Summary
ANVISA, Brazil’s medicines regulator, is asking for feedback on the regulatory pathway for biosimilars.
You may also be interested in...
Regulatory Reliance Key To Cancer Drug Access in Lower-Income Countries
Regulatory reliance will be vital in improving access to oncology medicines in low- and lower-middle income countries, delegates at a recent regulatory conference were told.
New German Law Tightens Volume Agreements & Links Prices To Wastage
New cost saving measures in Germany include mandatory volume agreements that will prompt companies to take more account of the size of the populations targeted by their products. Meanwhile, a new link between product wastage and prices should encourage some companies to think about their pack sizes.
New German Law Gives Payers More Power Over Drug Pricing
A new law aimed at limiting drug spending in Germany will mean that only companies with new products that offer high levels of added benefit will have full flexibility to negotiate prices.