October 11th 2021
By Skylar Jeremias
Ivo Abraham, PhD, a professor with University of Arizona Health Sciences in the Department of Pharmacy Practice, outlines the current trajectory and savings potential for granulocyte-colony stimulating factor (G-CSF) biosimilars and Neulasta Onpro (pegfilgrastim).
October 9th 2021
Biosimilar development companies report an approval in Canada and positive phase 3 findings in China for their bevaciumab biosimilars.
October 7th 2021
By Tony Hagen
A US District Court in Illinois has ruled that although trade secret theft may have occurred over an adalimumab biosimilar candidate, it happened far from the state. With only a very "attenuated" connection, there are no grounds to bring action against Alvotech in the case of purloined manufacturing data, the judge stated.
October 6th 2021
The court battle between AbbVie and Alvotech could be a defining victory in the struggle to bring biosimilar versions of adalimumab to market, but a yearlong court process must play out first.
October 2nd 2021
By Sarfaraz K. Niazi, PhD
The Center for Biosimilars® Advisory Board member Sarfaraz K. Niazi, PhD, explains an “against the grain” approach to tapping unmet need and revenue potential in biosimilars.
September 25th 2021
Biosimilar User Fee Act reviews have been slowed by the pandemic and the FDA has opened a public comment period as it plots the course through 2027.
September 23rd 2021
The Center for Biosimilars® spoke with George Williams, MD, clinical spokesperson for the American Academy of Ophthalmology (AAO), about the FDA’s recent approval of Byooviz (ranibizumab), the first biosimilar specifically approved for treatment of eye diseases.
September 21st 2021
Reykjavik, Iceland company Alvotech said the FDA review of its adalimumab candidate is held up by pandemic-related curbs on overseas inspections.
September 20th 2021
Investigators said TX05 met pathologic complete response criteria for equivalence to the originator product, Herceptin. The biosimilar candidate also fell within objective response rate, immunogenicity, safety, and tolerability margins for similarity.
September 19th 2021
Kirollos Hanna, PharmD, from the University of Minnesota Medical Center, discusses some of the tactics that biosimilar companies are employing in order to level the playing field and better compete against originator companies.
