Pharmaceutical and biotech companies are spending years and millions of dollars developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients the better.
The FDA approved 48 novel drugs in 2019, the third highest number of approvals in over two decades. Of the products approved, 17 were designated as fast track, 13 were breakthrough therapies, 28 were priority review and another 9 received accelerated approval (Figure 1). Sixty percent of the 48 novel drug approvals were designated in one or more of the four expedited categories. With additional novel drug products planned for approval over the next few years along with new and emerging modalities, it is imperative that companies invest adequate time and resources in strategic planning and preparation activities to ensure the best chances for a successful commercial launch.
“Ensuring that the sponsor company and manufacturing partner are aligned is absolutely a key to the success of a product launch. Catalent, having touched nearly 50% of FDA approvals in the last 10 years, has the expertise to bring biologics, small molecules, vaccines, and more to market for drug sponsors,” says Jason Spacek, Vice President, Commercial Operations, North America at Catalent Biologics.