November 25th 2023
A phase 1 analysis confirms that romiplostim biosimilar candidate GP40141 has comparable pharmacokinetic (PK) and pharmacodynamic (PD) parameters in healthy volunteers compared with the reference product.
BioRationality: FDA Launches a New Opportunity to Remove Redundant Trials of Biosimilars
November 6th 2023The FDA introduced a plan to improve clinical trials, including a provision to possibly eliminate clinical efficacy testing for biologic products, which evidence has suggested may not be necessary, according to Sarfaraz K. Niazi, PhD.
Eye on Pharma: New GI Data and Byooviz Interchangeability Propel Biosimilars Into the Future
October 25th 2023As Celltrion releases new data on its subcutaneous infliximab product in gastroenterology conditions, Samsung Bioepis secures an interchangeability designation for Byooviz, making it the second ranibizumab biosimilar to be deemed interchangeable with the reference product.
BioRationality—A DMF Route to Biosimilars: CDMOs Can Make Biosimilars Accessible and Affordable
October 16th 2023Sarfaraz K. Niazi, PhD, chronicles how drug master files (DMF) can be used in the biosimilar approval process and the role contract development and manufacturing organizations (CDMOs) can play in improving biosimilar accessibility.
Webinar: Experts Discuss Avenues to Improve Biosimilar Development Efficiency
October 4th 2023A recent webinar featured an in-depth discussion on the impacts that updated guidelines, a reduction in clinical efficacy testing, and biomarker analyses can have on the efficiency of biosimilar development.
BioRationality: Calling on Developers to Help Address Remaining Biosimilar Issues
October 3rd 2023Sarfaraz K. Niazi, PhD, summarized the citizen petitions he's filed to the FDA as well as changes he believes are needed to propel the biosimilar industry into the future, including calling on biosimilar manufacturers to help.
Part 3: BioRationality—FDA Webinar on Biosimilars Efficacy Testing Marks Major Step Forward
September 20th 2023In the final part of a 3-part series, Sarfaraz K. Niazi, PhD, gives his take on the FDA's recent workshop dedicated to streamlining biosimilar development and his opinion on what the industry can learn from the webinar presenters.
Part 2: FDA Workshop Shares Manufacturer Perspective on the Value of Clinical Efficacy Testing
September 18th 2023Although removing the requirement for clinical efficacy testing for biosimilar approval would reduce development costs of biosimilars, representatives from several biosimilar manufacturers argued in the second day of the FDA’s development workshop that clinical outcomes will not be affected.
Authors Suggest Major Policy Shifts to Boost Biosimilar Development, Accessibility
August 9th 2023Streamlining biosimilar development would permit biosimilar development of more and a wider variety of biological drugs, fast-tracking biosimilar development without impacting patient safety or effectiveness, according to an opinion piece.
BioRationality: The Adulthood of Biosimilars—Global Status and Future of Biosimilars
August 7th 2023Sarfaraz K. Niazi, PhD, gives an overview of the global biosimilar landscape, noting why some countries have biosimilars, including follow-on biologics and unbranded biologics, for certain products and why others do not.
Despite Global Increase in Amjevita Sales, US Sales Dropped 63%
August 5th 2023Despite global sales for Amjevita (adalimumab-atto) growing by 29% year-over-year and the agent being the first adalimumab biosimilar on the US market, sales in the United States dropped 63% from the first quarter to the second quarter of 2023.
Eye on Pharma: Omalizumab Results; Korean Insulin Launch; Quebec to Cover Byooviz
July 12th 2023Kashiv Biosciences announced positive phase 1 results for its omalizumab biosimilar; Dongkook Pharmaceutical shared the launch of an insulin glargine biosimilar (Glargia); and Quebec, a province in Canada, said it’s adding a ranibizumab biosimilar (Byooviz) to its reimbursement list.
The Age of Adalimumab Is Upon Us: How Stakeholders Can Prepare
June 28th 2023The Center for Biosimilars® provides an updated look on the adalimumab biosimilars that are coming down the US pipeline as well as what stakeholders need to know and how they can prepare ahead of the US launch of 8 adalimumab biosimilars in July 2023.
BioRationality: Biosimilars Are Not Doing Well—Time for a Change in Perspective
June 26th 2023In his latest column, Sarfaraz K. Niazi, PhD, takes a look at common misconceptions about biosimilar development and expresses how companies can seize new opportunities to save the US biosimilar market and generate profit.
BioRationality: New FDA Guideline Invites Biosimilar Developers to Reduce the Cost of Testing
June 12th 2023Sarfaraz K. Niazi, PhD, examined the new FDA guideline that acts as an invitation to biosimilar developers to decrease the cost of testing, potentially opening the door for companies to reduce nonclinical testing of biosimilars entirely.
Biorationality: Advice for the FDA, Biosimilar Developers on Reducing the Cost of Clinical Testing
May 15th 2023Although the FDA has consistently edited its testing guidelines for biosimilar developers over the years, clinical testing is still very expensive and time-consuming. Sarfaraz K. Niazi, PhD, offers the FDA and companies a plan of action for reducing clinical testing expenses for biosimilar products.