BERWYN, PA — AscellaHealth has unveiled its latest edition of the Specialty & Rare Pipeline Digest™, a vital digital resource that tracks developments in specialty and rare disease medications, including cell and gene therapies (CGTs) and biosimilars. This quarterly publication aims to inform stakeholders and decision-makers about the latest pipeline updates in the specialty drug market.
Recent data from AscellaHealth shows a notable increase in the approval of biosimilars by the FDA, rising from 47 in the first quarter to 60 by the third quarter. This growth provides more affordable healthcare options and improves patient access. The number of interchangeable biosimilars, which can be substituted at pharmacies without prescriber intervention, also rose from 8 to 14, offering significant cost-saving opportunities.
However, the progress in CGT approvals has been slower, with the number of approved gene therapies decreasing from seven in the second quarter to five in the third, while cell therapies remained constant at three approvals each quarter. Andy Szczotka, PharmD, AscellaHealth’s chief pharmacy officer, highlights the challenges faced in this area: “The number of approved gene therapies fell from seven in Q2 to five in Q3, while cell therapies stayed steady at three approvals for both quarters. This data underscores the complexities involved in the development, manufacturing and regulatory approval of these advanced treatments.”
Dea Belazi, CEO of AscellaHealth, emphasizes the growing impact of biosimilars in the market: “With biosimilar options continuing to grow, providers and healthcare systems will gain more tools for maintaining pricing sustainability.” He also acknowledges the hurdles faced by CGTs, noting that despite their potential, these therapies require complex clinical trials and face rigorous regulatory scrutiny.
AscellaHealth continues to support the commercialization of new therapies and enhance patient access through its comprehensive solutions, partnering with life science companies to navigate the pharmaceutical landscape. The continued advancements in biosimilars and CGTs are expected to play a critical role in shaping the future of personalized medicine.
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