Biosimilars Archives

Draft Guidance Issued on Device Presentations for Biosimilar and Interchangeable Biosimilar Products

By Bob Pollock Aug 03, 2026 Biologics Biosimilars Regulatory Affairs

On July 30, 2026, FDA issued a draft guidance (here) titled Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts Guidance for Industry. FDA goes into detail regarding what they term “presentation” (container closure systems (e.g., vials) and device constituent parts of combination products) and describes how firms should address […]

Jul

FDA Announces Biosimilar User Fee Rates for FY 2027

By Bob Pollock Jul 30, 2026 Biosimilars Regulatory Affairs User Fees

The Federal Register published FY 2027 user fee rates (here) for the biosimilar program, (known as BsUFA). In an unusual twist for various FDA user fees, the BsUFA fees either stayed constant or went down for FY 2027 relative to the FY 2026 fees. It is likely the success of the BsUFA program that has […]

Jul

Get Your Reading Glasses On – CDER Guidance Plans for 2026 Cite 85 Documents

By Bob Pollock Jul 17, 2026 ANDAs Bioequivalence Biologics Biosimilars BLA Compounding Generics Labeling NDA OGD PSGs Regulatory Affairs Unapproved Drugs

With four and a half months remaining in fiscal year 2026, the Center for Drug Evaluation and Research (CDER) has published the list of 85 new or revised guidance documents that it plans to release this year! The document (here) categories along with the number of anticipated guidances are as follows: Administrative/Procedural – 8 Artificial […]

Jul

CDMO Growth Creates Data Integrity Risks Across Company Boundaries

By Patrick Day Jul 09, 2026 ANDAs Biosimilars BLA Compliance IND NDA Supply chain

The pharmaceutical supply chain is no longer just a chain of physical materials, but rather a complex series of data, data-based decisions, and delegated responsibilities for that data. FDA’s CDER FY2024 Site Catalog reported 4,619 manufacturing sites globally, reflecting the broad scale of the regulated manufacturing network supporting the U.S. drug supply. Within that network, […]

Jul

HHS Unified Rule Agenda for 2026

By Bob Pollock Jul 08, 2026 ANDAs Biologics Biosimilars BLA Compounding Devices Dietary Supplements Labeling NDA Regulatory Affairs

The list is long (here) and there are some interesting regulatory items found in the agenda for FDA. Take some time and peruse them all as I will just highlight a few items of interest in this post. Here are some of the proposed rules that caught my attention: Current Good Manufacturing Practice for Outsourcing […]

Jun

Compliance With Clinical Trials Posting – Understanding the Requirements

By Bob Pollock Jun 23, 2026 Biologics Biosimilars Compliance Devices IND NDA Regulatory Affairs

Over the last six to eight months, the FDA’s activity regarding compliance with the required posting of ongoing and completed clinical trials has significantly increased, as evidenced by the issuance of multiple warning letters and letters of non-compliance to sponsors and/or principal investigators. To assist responsible parties in complying with the requirement to post on […]

Jun

If a Product Is Found to Be Safe, Should We Just Forget About Efficacy? Not On My Watch!

By Bob Pollock Jun 03, 2026 Approvals Biologics Biosimilars BLA NDA Regulatory Affairs

On June 2, 2026 in The Wall Street Journal, Charles L. Hooper and David R. Henderson wrote “…Remove efficacy from the FDA’s approval process and focus on safety alone. That would improve doctors’ ability to match patients with the best drugs and help Americans live longer, healthier lives. Medicine is a matchmaking exercise in which potentially beneficial drugs […]

May

An Interesting Issue That May Impact FDA and Industry

By Bob Pollock May 27, 2026 ANDAs Biologics Biosimilars BLA Confidentiality Device NDA

A Federal Register (FR) notice that appeared on today’s pre-publication page discusses a request for comments on a draft nondisclosure agreement (NDA) for federal employees. The notice (here) discusses the proposed NDA to affirm “[f]ederal employees’ acknowledgment of, and agreement to comply with, current legal obligations to safeguard non-public, confidential, or proprietary information, created or […]

May

Taking a close look at prescription labeling

FDLI Session Recap: Do You Copy? Biosimilars, Generics, Fast Tracks, and Fine Print

By Martin Shimer May 12, 2026 ANDAs Biosimilars Generics Regulatory Affairs

I had the good fortune to attend the FDLI Annual Meeting held on May 6th and 7th. The FDLI Annual Meeting is always a good conference where attendees are able to hear many great updates from the FDA and insights on issues related to our industry. This year was no exception, and the FDA had a […]

Mar

Prasad Out Again as the Camel’s Back Breaks

By Bob Pollock Mar 09, 2026 Biologics Biosimilars FDA

Just one too much controversies, just too many career FDAers’ decisions overridden, just too much change to vaccine recommendations, and, apparently, just one too many changes in previously agreed-upon requirements have led to the second departure of Vinay Prasad from the position of Director, Center for Biologics Evaluation and Research. Commissioner Makary announced that Prasad […]

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