December 4th 2023
Sarfaraz K. Niazi, PhD, comments on a poll he conducted revealing that many are still hesitant to remove clinical efficacy study requirements for biosimilars in his latest column.
BioRationality: A Dr Sarfaraz Niazi Column—Avoid Delays in Biosimilar Approvals Due to CRLs
February 27th 2023Although a complete response letter (CRL) is not an official rejection letter, it can result in approval delays by listing out shortcomings in an application and giving companies an opportunity to respond. In his latest column, Sarfaraz K. Niazi, PhD, goes over how companies can avoid these approval postponements.
IGBA Panelists Discuss the Global Reputation of Biosimilars, Generics
February 21st 2023Panelists at the annual meeting of the International Generic and Biosimilar Medicines Association (IGBA) offered insight into the current state of the global biosimilar and generic markets and why government agencies need to leverage these medicines to address challenges in the pharmaceutical space.
Contributor: The Promise of Biosimilars and the Harsh Reality of the US Market
February 20th 2023In theory, by offering a lower-cost treatment option, biosimilars would help drive access for countless patients who simply could not afford the brand-name biologic. However, biosimilars have also encountered the harsh realities of the US health care system and its market forces.
IGBA 2023: Dr Monique Mansoura Highlights the Intersection of Geopolitical Issues, Biopharma
February 19th 2023COVID-19 allowed governments to critically examine the biopharma space to increase access to vaccines, but there's still a way to go, according to Monique Mansoura, PhD, MBA, executive director of global health security and biotechnology at the MITRE Corporation, at the International Generic and Biosimilar Medicines Association’s annual meeting.
Access 2023: Panelists Weigh In on the Many Factors Influencing Biosimilar Uptake Patterns
February 16th 2023Two presentations and a panel discussion at the annual meeting of the Association for Accessible Medicines (Access 2023) went over the current state of biosimilar uptake and the factors that help determine whether a biosimilar will experience good adoption rates.
BioRationality: A Dr Sarfaraz Niazi Column—Misconceptions in the Adoption of Biosimilars
February 13th 2023Sarfaraz K. Niazi, PhD, goes over some misconceptions surrounding biosimilar adoption as well as some national efforts to make biosimilar uptake easier and biosimilar development more economically efficient.
Q&A: Patent Attorney Provides Insight Into Biosimilar Legal Challenges
February 7th 2023Geoff Biegler, JD, a principal at Fish & Richardson, an intellectual property law firm, expands on his presentation on biosimilar legal challenges throughout 2022, providing insight on the inner workings of the patent dance and how a Supreme Court decision could have an impact on future cases.
High Treatment Retention Following Biosimilar-to-Biosimilar Switch in Denmark
February 4th 2023A real-world study assessing the aftermath of Denmark implementing a nationwide mandatory switch from one infliximab to another found strong treatment retention rates, demonstrating the safety and tolerability of biosimilar-to-biosimilar switching.
FDA Updates Biosimilar Regulatory Research Program With Roadmap
February 2nd 2023The FDA published its research roadmap as part of the Biosimilars User Fee Act III regulatory research pilot program. The roadmap will allow stakeholders to see how the program will help the FDA enhance regulatory decision-making surrounding biosimilar development.
IRA Insulin Cap Could Have Saved Medicare Beneficiaries Millions in 2020
January 24th 2023A new report from HHS has revealed that if the Inflation Reduction Act (IRA) had been implemented in 2020, Medicare Part D beneficiaries could have saved a total of $734 million, averaging out to about $500 per member.
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.
Legal Experts Provide Updates on Biosimilar Patent Disputes in 2022
January 19th 2023Patent litigators from Fish & Richardson, an intellectual property law firm, regaled audiences during a webinar covering all the big biosimilar regulatory and legal decisions throughout 2022, including updates on patent disputes and antitrust investigations.
Study Compares Uptake, Prices of Biosimilars in US vs 2 European Countries
January 12th 2023A study assessing uptake rates and prices of biosimilars found that while the United States had significantly higher prices, the uptake in Germany and Switzerland, 2 European countries with national mechanisms for drug price negotiation, was slower.
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.
Dr Ivo Abraham Column: 1 Billion People Can Access Biosimilars; What About the Other 7 Billion?
November 30th 2022Now that the world population has reached 8 billion, Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, took a look at how high-income countries can increase accessibility to livesaving medicines to the 7 billion people who have limited access to biosimilars.
VOLTAIRE-X Findings in Patients With Chronic Plaque Psoriasis Supported Interchangeability
November 26th 2022The VOLTAIRE-X randomized controlled trial determined the adalimumab biosimilar BI 695501 (adalimumab-adbm, Cyltezo; Boehringer Ingelheim) met the FDA’s criteria to be designated as interchangeable with the reference product (Humira).
AAM's Craig Burton: Is the Biden Administration Doing Enough to Help Biosimilars?
November 13th 2022Craig Burton, senior vice president of policy and strategic alliances at the Association for Accessible Medicines and executive director of the Biosimilars Council, gives insight into the many health policies that the Biden administration has implemented in 2022 as well as their possible impact on biosimilar adoption.
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.