Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Drug Pricing Initiatives During the Trump Presidency
A changing competitive landscape: the role of the ITC in the biosimilars space
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
On June 10, 2025, Health Canada initiated a public consultation on proposed revisions to its Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. A notable update is the proposal to remove...more
As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023. Below are some of the top regulatory developments from 2023....more
The U.S. Supreme Court’s May 2023 decision in Amgen, Inc. v. Sanofi (Amgen) sent shock waves through the patent world, particularly in the chemical and biotech segments, due to its invalidation of Amgen patents based on a...more
On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued an initial guidance regarding the Medicare Drug Price Negotiation Program (Negotiation Program) established by the Inflation Reduction Act of 2022...more
2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more
There has been much discussion about FDA’s recently-issued guidance regarding the development and review of abbreviated new drug applications (“ANDAs”) during the COVID-19 pandemic. The guidance, “Development of Abbreviated...more
This month, a working group within the Pharmacy Directors Forum of the National Comprehensive Cancer Network (NCCN) has reviewed and highlighted “some of the potential challenges regarding adopting biosimilars into clinical...more
The FDA has released a draft guidance for industry entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act.” According to the FDA, the draft guidance is “intended to...more
Here are our picks for the most significant U.S. regulatory developments related to biosimilars in 2018: 1. FDA Releases Biosimilars Action Plan - In July, FDA released the Biosimilar Action Plan (BAP), which outlines...more
Yesterday, FDA released a series of guidances that aim to advance the agency’s biosimilars policy framework, along with a proposed rule on the definition of a “biological product,” which incorporates changes made by the...more
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...more
PMPRB News - PMPRB releases scoping paper relating to proposed amended Regulations - As previously reported, on December 2, 2017, Canada’s Governor-in-Council published proposed Regulations Amending the Patented...more
On November 15, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017. The Biosimilar User Fee Amendments of 2017 (BsUFA II)...more
On May 19, 2017, the period for submitting public comments on the FDA draft guidance on biosimilar interchangeability closed (for a discussion of the FDA draft guidance click here). The draft guidance was published on...more
In December 2016, the FDA published an industry guidance related to the Biologics Price Competition and Innovation Act. This guidance offers suggestions to sponsors on the design and use of clinical pharmacology studies to...more
On December 29, 2016, the FDA issued guidance to assist applicants seeking FDA approval of a proposed biosimilar product under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). To obtain such approval, an...more
FDA just released a final Guidance for Industry, “Nonproprietary Naming of Biological Products.” The guidance provides that naming for originator biological products, related biological products, and biosimilars should...more
The following are highlights of developments in Canadian life sciences intellectual property and regulatory law in 2016, updating our 2016 mid-year highlights. 1. Substantive patent law developments - Utility and...more
The FDA issued a new Guidance today, titled “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.” The Guidance is intended to “assist sponsors with the design and use of clinical...more
A recent court ruling and a new publication on guidelines for biosimilars in India may offer further guidance on what biosimilar and biologic stakeholders can expect from Indian regulatory authorities. In late March,...more
One of the FDA’s recent biosimilar guidance documents has drawn criticism for eliminating labeling information necessary for physicians to make prescribing decisions. The guidance document, titled, “Scientific Considerations...more
After finalizing three key guidance documents on biosimilars at the end of April (reported on our blog here), yesterday FDA released another “Question and Answer” guidance in draft form. The draft guidance is called...more
Biosimilars Are Generally Treated as Single Source Drugs - On March 30, 2015, in the wake of the first biosimilar product licensed by the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services...more
Guidance Issued on Payment for Biosimilars – On March 30, 2015, CMS released three guidance documents detailing the policies that will govern FDA-approved biosimilars under the Medicare Part B and Part D benefits, and how...more
On March 30, 2015, CMS released guidance addressing Medicare and Medicaid coverage for biosimilar drug products. The Medicare/Medicaid coverage guidance comes on the heels of the FDA’s landmark approval of a biosimilar...more