Speaker: Manufacturing process may be ‘long journey’ for biologics
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Key takeaways:
- Human cell and tissue products pass through either a biologic or device regulatory pathway.
- Homologous, minimally manipulated tissue-based products may qualify for a 361 exemption.
WASHINGTON — According to a presenter, the manufacturing process for orthobiologics is a long journey of acquiring sufficient data, an appropriately manufactured supply, approval from the FDA and reimbursement before going to market.
“There is a lot of work that has to go into getting to the place where you’re testing these [products] clinically, and then you have to get regulatory approval and, ultimately, reimbursement,” Scott P. Bruder, MD, PhD, said in his presentation at the American Academy of Orthopaedic Surgeons Next Generation of Biologics Symposium. The symposium was presented in collaboration with the Biologic Association.
Human cell and tissue products pass through either a biologic or device regulatory pathway, with cells or growth factors regulated through a biologic license application, and the preparation devices regulated through premarket approval or 510(k) application, according to Bruder.
However, tissue-based products that satisfy criteria of homologous use and minimal manipulation may qualify for a 361 exemption.
“What that means is it is a tissue-based product that is exempt from premarket review by the FDA,” Bruder said.
Although products eligible for 510(k) approval can get on the market, Bruder said there may not be an “opportunity to have substantial clinical evidence to get reimbursed through the pathway.” According to Bruder, while products that go through premarket approval or a biologic license application may be covered by third-party payers, products that do not have robust clinical evidence may not be covered.
“I’m afraid to say that there’s not a bright future for reimbursement on [platelet-rich plasma] PRP, [bone marrow aspirate concentrate] BMAC and 510(k)-cleared products for the preparation of point of care tissue,” Bruder said.
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Bruder SP. Understanding the FDA regulatory pathways for approval of orthobiologic products. Presented at: American Academy of Orthopaedic Surgeons Next Generation of Biologics Symposium; July 12, 2023; Washington, D.C.
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