AscellaHealth Releases Q3 2024 Specialty & Rare Pipeline Digest™: FDA-Approved Biosimilars Outpaces Cell and Gene Therapy Amid Complex Regulatory Challenges

BERWYN, Pa., Oct. 22, 2024 (GLOBE NEWSWIRE) — AscellaHealth, a global partner delivering customizable solutions to support the specialty pharmaceutical industry, today released its latest Specialty & Rare Pipeline Digest™, the industry’s most comprehensive digital resource of new, pending and upcoming specialty and rare disease drug launches, cell and gene therapies (CGTs) and biosimilars. This complimentary quarterly publication provides timely product updates to support the specialty drug market needs of stakeholders and decision-makers. “The latest data reveals continual growth in biosimilar approvals, while newly approved CGTs have seen only modest increases due to ongoing regulatory and manufacturing challenges,” says Andy Szczotka, PharmD, chief pharmacy officer, AscellaHealth. “Although these advanced therapies can be transformative for individuals with chronic conditions or rare disease lacking treatment options, the approval and expansion rates for CGTs remain slow.” According to the data, FDA-approved biosimilars increased from 47 in Q1 to 60 by Q3, providing additional choices for more affordable healthcare treatment options. The rise in interchangeable biosimilars, from 8 to 14, emphasizes the value of biologics that can be substituted at the pharmacy, where state laws permit, for the reference product without the need for a prescriber’s intervention. Interchangeable biosimilars offer opportunities to enhance patient access and lower healthcare costs, similar to the way generic drugs are routinely substituted for brand-name drugs. Szczotka explains, “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. Although CGTs have transformative potential, the approval process remains lengthy and resource intensive.” Dea Belazi, CEO, AscellaHealth, notes that biosimilars are gaining momentum in the market, providing significant cost-saving opportunities and increasing patient access to essential treatments: “With biosimilar options continuing to grow, providers and healthcare systems will gain more tools for maintaining pricing sustainability,” he says. “The modest progress in CGT approvals reflects the unique challenges these therapies face, including complex clinical trials, regulatory scrutiny and the intricate nature of the manufacturing process. However, every new approval is a vital step forward in advancing personalized medicine for patients with unmet medical needs.” AscellaHealth facilitates drug commercialization and broadens patient access with a range of innovative end-to-end solutions that support every phase of the product lifecycle. From clinical trials to ensuring smooth patient transitions onto approved therapies, AscellaHealth partners with global life science companies to navigate the complexities of bringing specialty pharmaceuticals to market and improving patient care throughout the entire care continuum. Access the latest Specialty & Rare Pipeline Digest™ here. About AscellaHealth LLCAscellaHealth is a global partner that delivers proven end-to-end solutions to both life sciences and healthcare companies to enhance the quality of life for patients with complex, chronic conditions. A dedicated team gets critical healthcare products from manufacturers to patients while ensuring an efficient flow of funds between payers and pharma. Visit www.AscellaHealth.com. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/a348a29e-eab9-4437-a799-0205007d1ba8 This press release was published by a CLEAR® Verified individual.CONTACT: Media:
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