On June 25, 2026, the U.S. Food and Drug Administration (FDA) announced the availability of revised draft guidance titled “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products.” The original draft guidance was issued in December 2019. When finalized, the revised draft guidance will replace the FDA’s 1998…
This month, FDA issued its new final guidance to replace a draft guidance that issued on May 22, 2019 titled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry”. This final guidance outlines the FDA’s “recommendations on the design and evaluation of comparative analytical…
In March 2023, the FDA issued a final guidance, titled “Q13 Continuous Manufacturing of Drug Substances and Drug Products” that describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM).” CM refers to “the continuous feeding of input materials into, the transformation of…
In May 2022, Xbrane announced that it had withdrawn its biologics license application (BLA) for its ranibizumab biosimilar of LUCENTIS®. On July 4, 2022, Xbrane announced that based on comments and recommendations in a General Advice letter received from FDA, “Xbrane plans to resubmit the [ranibizumab] BLA during 2022,” and that…
As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year: 1. President Biden Signs Orange Book Transparency Act In January, we reported that President Biden signed H.R. 1503 (the Orange Book Transparency Act of 2020). The Orange Book Transparency Act requires NDA holders to…
On September 20, 2021, the FDA issued a revised final guidance for industry entitled “Questions and Answers on Biosimilar Development and the BPCI Act” and a third revision to its draft guidance entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act.” According to FDA, the guidance…
The FDA has released a draft guidance for industry entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act.” According to the FDA, the draft guidance is “intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable products, as well as…
The FDA issued a draft guidance today titled “Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed.” In this guidance, the FDA addresses the following issues: Submission of an application seeking licensure of a proposed biosimilar or proposed interchangeable…
Last week, the FDA compiled a preliminary list of NDAs that will be converted to BLAs in view of the new interpretation of the terms “protein” and “biological product” in the FDA’s “Deemed To Be A License” draft guidance, which was released in December 2018. In the draft guidance, the…
This month the FDA published its Guidance for Industry titled “Considerations in Demonstrating Interchangeability With a Reference Product”. The guidance is “intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under…