Another busy schedule for another virtual meeting. AAM has indicated that it will be back to in-person meetings with the February 2022 annual meeting. We are all looking forward to being able to shake hands, see each other in person, and chat face-to-face. Don’t know about you but, for me, virtual meetings just don’t have the same impact that getting together in person does. That said, hope to see you all at the annual AAM meeting.
Getting back to the sessions on day one of the GRx+Biosims meeting, Dan Leonard, President and CEO of AAM, gave the state of the association, speaking about all of the issues of the day and the challenges that the generics and biosimilars industries are currently addressing. Supply chain demands, GDUFA and BSUFA negotiations and commitments, as well as the pressure on the Agency regarding inspections, and the impact that COVID has had on the entire world were among the issues covered. Dr. Woodcock, Acting Commissioner, spoke about compliance issues related to the inability to perform most on-site inspections during the pandemic and the alternate methods being employed to assist in clearing some of the routine and pre-approval inspections, while some mission-critical inspections are being conducted in person. She also discussed the general movement to evaluate and validate alternate bioequivalence methods for complex products.
Jacqueline Corrigan-Curay, J.D., M.D., Principal Deputy Center Director, CDER, spoke about some of the firsts for the year, including the first complex generic of glucagon for treating severe hypoglycemia. This synthetic peptide’s approval was possible because of FDA research on analytical methods for peptides and immunogenicity testing for peptides; the first complex generic parenteral iron product was made possible by scientific advancements in characterization techniques and advanced bioequivalence study designs. Approval for a generic loteprednol etabonate ophthalmic suspension was bolstered by investments in particle‑size characterization and eye models to support a more efficient in vitro bioequivalence method.
She also spoke about the ongoing GDUFA regulatory priority issues and the impact they will have on shaping the ability to approve other complex drug products that had not even existed (or been contemplated) at the time of Hatch-Waxman’s passage.
Dr. Corrigan-Curay also spoke about an issue in GDUFA III that I have frequently blogged about – efficiency in the review and approval processes, as well as the transparency of the ANDA reviews, which will hopefully lead to faster approvals. Three specific areas that the GDUFA III commitment letter focused on were:
- Advancing earlier approval through enhanced communication and the review process.
- Enhancing the development, assessment, and approval of complex generic products; and
- Assuring a sound financial footing through GDUFA III.
During most of the rest of the morning, various speakers concentrated on biosimilars by noting that there have been thirty-one biosimilar approvals to date for eleven different reference products, with twenty biosimilars currently being marketed; the other ten biosimilars approved are still dealing with patent or exclusivity issues prior to being able to be launched. There have been a number of firsts this year, including approvals of the first interchangeable biosimilar insulin glargine (Semlee), as well as the first interchangeable adalimumab (Cyltezo, the second interchangeable biosimilar to be approved since the program was first authorized), and the first ophthalmic biosimilar (Byooviz). The speaker also noted that, while there is increasing market uptake of biosimilars, particularly in the area of oncology, there are also challenges, such as limited uptake outside of the oncology field, and the biosimilar product development process is still costly and lengthy.