Last year, biosimilar developer Pfizer submitted a citizen petition to the FDA in which it called on the agency to issue guidance clarifying how drug sponsors can communicate about biosimilars. After the petition was filed, The Center for Biosimilars® invited an expert group of stakeholders to discuss misinformation about biosimilars as well as what steps are necessary to root out and address the misinformation.
Last year, biosimilar developer Pfizer submitted a citizen petition to the FDA in which it called on the agency to issue guidance clarifying how drug sponsors can communicate about biosimilars. According to Pfizer, misleading statements were creating create undue confusion about these products. After the petition was filed, The Center for Biosimilars® invited an expert group of stakeholders to discuss misinformation about biosimilars as well as what steps are necessary to root out and address the misinformation.
This time on the podcast, we’re sharing a portion of that discussion with our listeners.
Want to hear more of the discussion? Click here for video of the full panel.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion
April 10th 2024A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.