April 17th 2024
Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Contributor: The US Biosimilar Market Outlook for 2023
January 24th 2023Sophia Z. Humphreys, PharmD, MHA, BCBBS, of Sutter Health in Sacramento, California, details the regulatory decisions from 2022, what's to come in 2023, and how the US biosimilars market is expected to shift over the next 5 years.
Eye on Pharma: New Partnerships; Samsung Adalimumab Updates; Phase 3 Ustekinumab Results
January 22nd 2023Alteogen and Alvotech announce updates for their respective license partnerships; Samsung Bioepis speeds up interchangeability study for its adalimumab biosimilar; Dong-A ST shares positive phase 3 results for its ustekinumab biosimilar.
Dr Ivo Abraham Column: Biologics and Biosimilars—Harnessing Regulatory Data for Value, Access
January 9th 2023Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, demonstrates why regulatory bodies in the United States shouldn't look at economic evaluations when reviewing regulatory data for biosimilars in his latest column.
FDA Accepts BLA for Alvotech Ustekinumab Biosimilar
January 6th 2023Alvotech, an Iceland-based company, announced that the FDA accepted its biologics license application (BLA) for its proposed ustekinumab biosimilar referencing Stelara. The company said it expects the FDA’s decision in the second half of 2023.
BioRationality—A Dr. Sarfaraz Niazi Column: Lessons From 2022 Biosimilar Events
January 4th 2023Sarfaraz K. Niazi, PhD, summarizes some of the lessons that the entire biosimilar industry can take away from 2022, including what new legislation and policy changes could mean for future biosimilar development.
Prescribers’ Perspectives on Strategies for Increasing Biosimilar Adoption
December 17th 2022Despite recent steps taken by the FDA to streamline approvals and increase availability for biosimilars, biosimilar adoption has been slow and primarily driven by payers in the United States, signaling that more needs to be done to encourage adoption, according to experts at a virtual workshop hosted by the FDA and the University of Maryland.
Dr Joseph Alvarnas Highlights the Current State of the Oncology Biosimilar Market
November 9th 2022Joseph Alvarnas, MD, vice president of government affairs at City of Hope and chief clinical adviser of AccessHope, explains what the recent FDA approvals of Stimufend and Vegzelma, 2 oncology biosimilars, says about the current state of the oncology biosimilar space.
BioRationality: A Dr Sarfaraz Niazi Column—FDA Launches Biosimilar Regulatory Science Program
November 7th 2022Sarfaraz K. Niazi, PhD, dived into the benefits of the FDA's recently announced Biosimilar Regulatory Science Program, which is expected to help progress biosimilar development and simplify evaluations for interchangeability status.
Saskatchewan Becomes Sixth Canadian Province to Implement a Biosimilar Switching Policy
October 20th 2022Saskatchewan joined 5 provinces and 1 territory in implementing a biosimilar switching policy, allowing for reference products to be switched out for biosimilars and lowering drug costs for the province’s public health plan.
Amgen Report: Biosimilars Have Saved $21 Billion in 6 Years
October 19th 2022Amgen’s ninth edition of its Biosimilar Trends Report explores the evolution of the US biosimilar industry, including current trends, predictions for the next few years, advice for stakeholders going forward, and insight into how reimbursement and other policies could develop.
Advocacy Organization Calls for Ontario to Switch Patients to Biosimilars
October 11th 2022Biosimilars Canada, a national association representing the Canadian biosimilar industry, held a press conference calling on Ontario, the province containing the nation’s capital, to institute a biosimilars switching policy.
BioRationality: a Dr Sarfaraz Niazi Column—The EMA Declares Biosimilars Interchangeable
October 3rd 2022Sarfaraz K. Niazi, PhD, explains the significance of the European Medicines Agency (EMA) declaring that biosimilars are interchangeable with their reference products and calls for the United States to do the same in the first installment of his new monthly column.