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for industry entitled “Questions and Answers on Biosimilar Development and the BPCI Act” and a third revision to its draft guidance entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act.”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The FDA has released a draft guidance for industry entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act.” According to the FDA, the draft guidance is “intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable products, as well as…
The FDA issued a draft guidance today titled “Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed.”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in view of the new interpretation of the terms “protein” and “biological product” in the FDA’s “Deemed To Be A License” draft guidance, which was released in December 2018. In the draft guidance, the…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…
Today, the FDA issued four new biosimilar guidances, as well as a proposed rule. According to a statement by FDA Commissioner Scott Gottlieb, two of the guidance documents—the draft guidance titled “The ‘Deemed to be a License’ Provision of the BPCI Act Questions and Answers” and the final guidance “Interpretation…
The Association for Accessible Medicines (AAM) and Biosimilars Council submitted comments to FDA two weeks ago regarding “the biosimilars action plan and ways to facilitate competition” in the biosimilars industry. Collectively referred to in the comments as AAM, and the “sole association representing America’s generic pharmaceutical sector in the United States,”…
Last week, FDA published its draft guidance on civil money penalties relating to the ClinicalTrials.gov data bank to the federal register. The guidance addresses how the FDA Centers (CDER, CBER, and CDRH, for drug, biological, and device products, respectively) identify whether parties have failed to submit required clinical trial registrations, results,…
Recently, the FDA released industry guidance regarding biosimilar product labeling, which is entitled “Labeling for Biosimilar Products” (“Biosimilars Labeling Guidance”). The Biosimilars Labeling Guidance provides recommendations for biosimilar product labeling, specifically for the proposed package insert, and is intended to help applicants in drafting labels for an aBLA. Some highlights…