A collection of associations for higher education wrote to FDA Commissioner Margaret Hamburg urging a requirement for biosimilar applicants to certify that they have complied with the information exchange and patent dispute resolution provisions of the BPCIA. The concern raised is that: “biosmilar sponsors can effectively circumvent every patent litigation provision of the statute simply… Continue Reading
Tag Archives: biosimilars
EMA takes steps toward facilitating global clinical trials for biosimilars
Applicants for marketing authorisation for biosimilars in the European Union (“EU”), under certain conditions, will be able in the near future to use batches of reference biological medicinal products sourced from outside the European Economic Area (“EEA”) in pre-clinical and clinical studies that are part of the comparability exercise preceding authorisation of biosimilars. On 28… Continue Reading