receive 5 years of exclusivity, and biologics receive 12 years; patents can still block approval or launch. In the European Union, the standard “8+2+1” framework applies—8 years of data exclusivity followed by 2 years of market exclusivity, with a possible additional year for a new indication that provides clinical benefit—and patent rights must still be respected. Either way, once competition is permitted, the launch of a generic product provides more affordable alternatives for patients and healthcare systems. For companies looking to develop new generic medicines, early and careful development and planning can mean that the product is ready to enter the market as soon as it is permitted, and give commercial advantages over competitors. Safety and efficacy of drugs is crucial, whether they are innovator drugs or generics. Through careful bioequivalence studies and adherence to regulatory requirements, companies can bring safe and effective generics to patients, and with experienced and integrated partners, the process can be streamlined to reduce the time and cost, allowing patients to have access to reliable and affordable healthcare options. Reference 1. Comparing Generic Drug Markets in Europe and the United States: Prices, Volumes, and Spending https://pubmed.ncbi.nlm.nih.gov/28895227/ ADRAGOS PHARMA JOHN KYTARIOLOS Head of Clinical & Scientific Affairs Adragos Pharma 84 TWENTYFOURSEVENBIOPHARMA Issue 3 / October 2025
RkJQdWJsaXNoZXIy MjY2OTA4MA==