GRx+Biosims

Panelists Discuss Regulatory Perspective on Biosimilars

December 20th 2021

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

FDA Official Addresses Unanswered Questions About Interchangeable Biosimilars

November 10th 2021

Article

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.

FDA’s Woodcock Says Agency Has Resumed Normal Review Pace for Biosimilars, Generics

November 8th 2021

Article

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

Experts See Progress, Not Perfection, in the Biosimilar Reimbursement Landscape

September 9th 2018

Article

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.

A Holistic Approach is Crucial for Biosimilar Uptake

September 8th 2018

Article

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.

FDA Has a Duty to Instill Confidence in Biosimilars, Experts Say

September 7th 2018

Article

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.

EU and US Stakeholders Discuss Experience With Switching

September 6th 2018

Article

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.”

More Biosimilar Approvals Are Not Equal to Increased Competition, Stakeholders Say

September 5th 2018

Article

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.