July 27th 2023
By Justina Petrullo
Reference bevacizumab and proposed biosimilar (BAT1706) demonstrate high similarity to each other.
July 24th 2023
By Sarfaraz K. Niazi, PhD
Sarfaraz K. Niazi, PhD, details his efforts to encourage congressional leaders to draft legislation that would remove interchangeability requirements and animal toxicology studies for biosimilars.
July 12th 2023
By Skylar Jeremias
Kashiv 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.
July 10th 2023
Sarfaraz K. Niazi, PhD, flagged an upcoming FDA meeting where stakeholders can make public comment on whether clinical efficacy testing for biosimilars is necessary for regulatory approval.
June 28th 2023
The 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.
June 26th 2023
In 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.
June 23rd 2023
By Deana Ferreri, PhD
The ranibizumab biosimilar XSB-001 (Ximluci) demonstrated biosimilarity to the originator (Lucentis) in a phase 3 trial in neovascular age-related macular degeneration (nAMD).
June 12th 2023
Sarfaraz 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.
May 30th 2023
In his latest column, Sarfaraz K. Niazi, PhD, went over some best practices for implementing innovative solutions for the purposes of streamlining biosimilar development.
May 20th 2023
Authors of a new in vitro study said Sanofi’s biosimilar SAR341402, approved in June 2020 by the European Medicines Agency for use in insulin pumps, had similar stability compared with the originator under stress conditions in their experiments.
