If you’d like to receive updates straight to your inbox, sign up here.
This month, the ramarketing review explores the most important topics hitting the headlines in September, including the news of the FDA looking for ways to combat the predicted winter surge in COVID-19 cases and hospitalizations, as well as updates to interchangeability statements for interchangeable biosimilars…
FDA greenlights updated COVID-19 shots, making fall booster rollout imminent
In a pivotal development in the pharmaceutical landscape, the FDA’s approval of updated COVID-19 booster shots from Pfizer/BioNTech and Moderna marks a significant milestone in the post-pandemic era. This move follows the FDA’s rigorous evaluation of the vaccines’ safety, effectiveness and manufacturing quality.
The green light for updated shots allows for their rollout in the upcoming fall season, with the pharma community awaiting the recommendation of these boosters by the CDC’s vaccine advisors.
Notably absent from the FDA’s announcement was the Novavax vaccine, despite the company’s asserted readiness for distribution. The exclusion of Novavax from the FDA’s actions remains unexplained.
Moderna recently released compelling data demonstrating the efficacy of their updated booster against the BA.2.86 variant, also known as Pirola. This variant has shown the potential to evade immunity from prior vaccination or infection. Pfizer and BioNTech’s updated booster, on the other hand, has been approved for individuals aged 12 and older, regardless of their prior vaccination status. It is important to note that their vaccine for children aged 6 months to 11 years received emergency use authorization, which is a lower regulatory requirement compared with full approval.
Both Pfizer CEO Albert Bourla and BioNTech CEO Uğur Şahin expressed their commitment to adapting vaccines to evolving variants to provide global populations with COVID-19 vaccines that are effective against any circulating virus strains. Encouraging the uptake of these boosters is likely to pose a challenge, despite health officials’ prior efforts. However, experts expect increased acceptance over time.
FDA reverses plans to pull interchangeability statement from labels of interchangeable biosimilars
In a recent update, the FDA has shed light on the evolving landscape of biosimilar labeling through its Purple Book guidance. Notably, interchangeability information about biosimilars will now be found in the Purple Book, not on labels. This move is set to impact not only patients and prescribers but also many companies in the pharma space.
The Purple Book can help patients and prescribers “easily identify” approved biosimilars and interchangeable biosimilars. The FDA suggests key changes for biosimilar labels, including using a biosimilarity statement beneath the initial U.S. approval and incorporating relevant data from the reference product’s label, with necessary modifications, including immunogenicity data.
This shift has ignited debate in Congress, with Amgen opposing the removal of interchangeability designation to maintain FDA flexibility and market confidence. The focus is now on the Senate, with discussions in November aiming to cover interchangeability removal, two-tier biosimilar and clinical efficacy requirements. Any decisions made are likely to impact the pharma industry in the future.
Stay tuned for next month’s ramarketing insights instalment — who will be September’s guest expert? Remember, you need to be subscribed to our mailing list to find out…
18th July, 2023
Mergers and acquisitions are nothing new, but the rise of social media over the...Read more
2nd February, 2023
Learn more about how our ramfam helps each other maintain good mental health. Get...Read more