September 20th 2023
By Sarfaraz K. Niazi, PhD
In 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.
September 18th 2023
By Skylar Jeremias
Although 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.
September 4th 2023
Sarfaraz K. Niazi, PhD, reacts to CMS' list of the first 10 drugs chosen for price negotiation under the Inflation Reduction Act (IRA), including 3 biologics with no biosimilar competition.
August 25th 2023
The FDA approved its first biosimilar indicated for multiple sclerosis (MS), Sandoz’ Tyruko (natalizumab-sztn), a biosimilar referencing Tysabi (natalizumab).
August 24th 2023
By Justina Petrullo
Biosimilar teriparatide improves bone mineral density (BMD) when patients with osteoporosis are treated for a year or more.
August 21st 2023
Sarfaraz K. Niazi, PhD, recapped his answers to a recent interview where he discussed his predictions on the future of the biosimilar industry in the United States.
August 20th 2023
On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, expanded on ways to make biosimilar development faster and cheaper without compromising on safety and efficacy and how these practices can ensure a sustainable market for the future.
August 9th 2023
Streamlining 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.
August 7th 2023
Sarfaraz 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.
August 5th 2023
Despite 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.
