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 13th 2023
An FDA workshop featuring regulators from around the world provided the regulatory perspective on how each government determines whether a biosimilar is clinically equivalent to their reference product, highlighting the science behind their development guidelines.
September 10th 2023
Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, explains the value of interchangeability in the adalimumab space and predicts whether interchangeable biosimilars will become leaders in adoption.
September 9th 2023
An approval in Australia and positive recommendations for 2 biosimilars in Europe bring hope for more affordable biologics around the world. However, another settlement for a US ustekinumab biosimilar showcases that some barriers remain.
September 7th 2023
By Luke Halpern
Perhaps the most significant development in the pharmaceutical industry in decades, crops of biosimilars are being approved and are ready for distribution. What lies next, in terms of legislation and the impact on pharmacists, remains to be seen.
August 29th 2023
Stelara (ustekinumab) and Enbrel (etanercept), 2 originator medications that will face biosimilar competition within the next decade, were among the 10 preliminary drugs chosen for Medicare price negotiation under the Inflation Reduction Act (IRA).
August 25th 2023
The FDA approved its first biosimilar indicated for multiple sclerosis (MS), Sandoz’ Tyruko (natalizumab-sztn), a biosimilar referencing Tysabi (natalizumab).
August 9th 2023
By Justina Petrullo
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.
July 26th 2023
Formycon and Celltrion announced the FDA submissions for their aflibercept biosimilars; the European Medicines Agency accepted a marketing authorization application for an ustekinumab biosimilar; and Roche filed suit against Biogen over a tocilizumab biosimilar.
