There is great strength in numbers, and joining forces with some of the world’s most influential companies in the biosimilar industry will position Biorasi to have a more significant impact on biosimilar drug development. To this end, Biorasi is proud to announce that the company is now a member organization of the GPhA Biosimilars Council, a division of the Generic Pharmaceuticals Association (GPhA). This newly minted alliance provides Biorasi with the opportunity to work with the world’s leading-edge biosimilar entities — and help to influence policies, form best practices, and promote science-based research and findings about biosimilar drugs.
“By interacting with other member organizations — including the U.S. Food and Drug Administration (FDA), regulatory agencies, pharmaceutical and biotech companies, and legislators — our team can have an impact on legislation and regulation around clinical developments to foster the rapid approval of biosimilars,” said Stephanie Finnegan, President, Divisional Operations for Biorasi. “We are honored to be included in this esteemed group, and we hope to be able to contribute and add value around the clinical development of these molecules.”
The Impetus for the Council
GPhA formed the Council in order to strengthen its presence in the biosimilar industry and promote patient access to biosimilar medicines. Compared with the generics industry, which has been around for about 50 years, the biosimilar industry is relatively new. Biosimilars launched in Europe in 2005, and in the United States, the FDA began legislating drug approvals in 2010, formally approving the first biosimilar in 2014. Finnegan explained that because biosimilar drugs are evolving in the way generic drugs did, the creation of the GPhA’s biosimilar group and the Council is a logical progression.
“Everyone within the GPhA Biosimilars Council is benefitting from the experience of others. Biosimilars are a new area and we are forging new paths. There are no clear-cut rules to getting these drugs approved,” Finnegan added. “As the only clinical research organization in the group, we have the tremendous opportunity to give back to the regulators by offering a new perspective from those of us on the ground-floor of biosimilar clinical development. Hopefully this thought leadership around program design and bringing to light the major issues currently faced by biosimilar developers will benefit not only our own clients, but the industry as a whole.
Learn more about the emerging opportunities of biosimilars, and how Biorasi is managing the complexities of biosimilar drug developments.