Here are the top 5 biosimilar articles for the week of September 20, 2021.
Hi, I’m Skylar Jeremias for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.
Here are the top 5 biosimilar articles for the week of September 20, 2021.
Number 5: Investigators in China reported positive equivalence findings from a phase 3 trial of a bevacizumab biosimilar candidate (MIL60) and platinum-based chemotherapy as first-line treatment in Chinese patients with recurrent or advanced non–small cell lung cancer (NSCLC).
Number 4: A phase 3 study of a trastuzumab biosimilar candidate and the reference product (Herceptin) has demonstrated equivalence in patients with human epidermal growth factor receptor 2 (HER2)-positive early stage breast cancer, according to findings presented at the European Society for Medical Oncology (ESMO) Congress 2021.
Number 3: Alvotech gained an EU marketing recommendation for AVT02, a proposed adalimumab biosimilar; New Zealand may give preferential status to Amgen's adalimumab biosimilar; and BioFactura looks to deliver ustekinumab via a robotic pill.
Number 2: Alvotech said the FDA review of its high concentration, citrate-free adalimumab biosimilar candidate (AVT02) is held up by pandemic-related curbs on overseas inspections.
Number 1: The FDA has approved the first ranibizumab biosimilar (Byooviz, SB11) for multiple ophthalmologic conditions, although market launch is at least 9 months away, owing to patent protections on the originator product.
To read all of these articles and more, visit centerforbiosimilars.com.
BioRationality: Should mRNA Copies Be Filed as NDAs or Biosimilars?
November 4th 2024The article by Sarfaraz K. Niazi, PhD, argues that the FDA’s classification of future copies of messenger RNA (mRNA) products could be reconsidered, suggesting they might be eligible for new drug applications (NDAs) or a hybrid biosimilar category due to their unique characteristics and increasing prevalence.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Panelists Stress Stakeholder Education to Build Confidence in Biosimilars
October 31st 2024By expanding educational initiatives to clarify biosimilar safety, efficacy, and interchangeability, stakeholders can foster trust, improve access, and ensure that biosimilars are widely accepted as high-quality, cost-effective alternatives to originator biologics.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Enhancing Adoption of Infused Biosimilars for a Sustainable Future
October 30th 2024An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.
Competitive Pricing in Biosimilars: How Adalimumab Could Shape the Industry
Published: October 29th 2024 | Updated: October 29th 2024Sophia Humphreys, PharmD, MHA, BCBBS, of Sutter Health notes that although initial adoption of adalimumab biosimilars remained low in 2023, competitive pricing pressures have already benefited patients and the health care sector.