GRx+Biosims

By expanding educational initiatives to clarify biosimilar safety, efficacy, and interchangeability, stakeholders can foster trust, improve access, and ensure that biosimilars are widely accepted as high-quality, cost-effective alternatives to originator biologics.

Panelists emphasized the need for transparency and policy reforms in pharmacy benefit management (PBM) to improve accessibility, affordability, and fair competition for adalimumab biosimilars.

At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, stressed the urgent need for data transparency in the global supply chain and the role of collaboration and artificial intelligence in ensuring the resilience of biosimilar and generic drug production.

At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.

At the GRx+Biosims conference, a fireside chat highlighted the need to streamline biosimilar development and strengthen industry collaboration, with Sarah Yim, MD, of the FDA, emphasizing education's key role in building trust and adoption.

At the 2024 GRx+Biosims conference, industry leaders and regulatory experts underscored the urgency of unifying global standards and simplifying the biosimilar development process, sharing insights on recent advancements and the necessity for greater collaboration between manufacturers and regulatory agencies.

At the GRx+Biosims 2024 conference, panelists explored challenges and progress in biosimilar interchangeability regulations in the US, discussing the FDA's new draft guidance, the removal of switching study requirements, and the need for more education to reduce misinformation and improve biosimilar uptake.

A trio of regulatory experts discuss the current standing of biosimilar policy in the United States and expectations going forward.

Sarah Yim, MD, provided a point-by-point overview of the FDA's efforts to clarify the role of the interchangeable biosimilar designation, improve communication with manufacturers, and pay for biosimilar regulatory reviews.

Janet Woodcock, MD, acting commissioner of the FDA, said the agency is meeting with biosimilar developers for biosimilars for 46 reference products.

At a panel at the GRx+Biosims 2018, Molly Burich, MS, director of public policy for biosimilars and reimbursement at Boehringer Ingelheim, and Melissa Andel, MPP, vice president of health policy at Applied Policy, discussed the impact that US policy developments are having and will continue to have on the biosimilars market.

Alex Brill, CEO of Matrix Global Advisors, gave a presentation during the GRx+Biosims 2018 conference in Baltimore, Maryland that discussed the barriers to increased uptake of biosimilars in the United States, and how to address those issues.

In a session held at the GRx+Biosims 2018 conference in Baltimore, Maryland, Gillian Woollett, MD, DPhil, senior vice president of Avalere Health, and Michelle Lee-Bourner, head of regulatory affairs for biologics and respiratory products at Mylan, discussed experience with and expectations for biosimilar regulation.

Contrary to experience in the United States thus far, Europe has also seen what Marc-Alexander Mahl, MD, describes as “widespread support for switching biosimilars medicines under the supervision of a healthcare provider.” In fact, regulatory bodies in the EU have spoken out stating that “In our opinion, switching patients from the originator to a biosimilar medicine or vice versa can be considered safe.”

While the “FDA deservers tremendous credit to enhance and expedite [biosimilars]… there is also a reluctance or hesitation to provide a full account that while the rate of approvals has picked up, the amount of biosimilars on the market [remains low]. Approval is not a synonym for competition," said Chester Davis of the Association for Accessible Medicines.