February 14th 2023
By Skylar Jeremias
Biocon Biologics and its partner Viatris received a complete response letter (CRL) for their biosimilar referencing Avastin (bevacizumab), the second CRL for the companies in 2023. The news comes as Biocon publishes increased revenues for biosimilars and generics.
February 13th 2023
By Sarfaraz K. Niazi, PhD
Sarfaraz 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.
February 6th 2023
Sandoz announced that the FDA has accepted the company’s biologics license application (BLA) for its denosumab biosimilar candidate for review.
February 2nd 2023
The 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.
January 30th 2023
Sarfaraz K. Niazi, PhD, explains the FDA's changes to the drug review process, the significance of each change, and the published pieces of work that helped inform the FDA's decisions.
January 29th 2023
On this episode of Not So Different, the FDA’s Sarah Yim, MD, discusses how the FDA is working to improve public trust in ophthalmology biosimilars and interchangeable products as part of a 3-part multimedia interview series.
January 26th 2023
Saudi Arabia approved an adalimumab biosimilar, a denosumab biosimilar entered the market in the Republic of Korea, and Dr. Reddy’s Laboratories announced the completion of a phase 3 study for its rituximab biosimilar.
January 24th 2023
By Sophia Z. Humphreys, PharmD, MHA
Sophia 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.
January 22nd 2023
Alteogen and Alvotech announce updates for their respective license partnerships; Samsung Bioepis speeds up interchangeability study for its adalimumab biosimilar; Dong-A ST shares positive phase 3 results for its ustekinumab biosimilar.
January 17th 2023
The United Kingdom has approved STADA Arzneimittel and Xbrane Biopharma’s Ximluci, a ranibizumab biosimilar referencing Lucentis, for the treatment of retinal conditions.
