Bruce A. Feinberg, DO: Would you still want to be doing pharmacovigilance postmarket release for the Mylan product if, and when, it comes to market?
Hope S. Rugo, MD: There’s no question that pharmacovigilance is incredibly important for all agents. I always tell people, “This is a biosimilar, so it’s very different from using another drug.” But, when you think about it, when any drug goes on the market, pharmacovigilance is incredibly important. In something as simple as a nonsteroidal, we saw a drug go off the market, Vioxx, because of postmarketing vigilance. So, I think that this is very important for all agents, when you have a new product going on the market. And a biosimilar is a new product, so pharmacovigilance is going to be critical. That is part of the regulatory direction for these agents, so pharmacovigilance will be part of this.
In terms of whether the Mylan product will go on the market or not, I think the study met all of the criteria set forth by the regulatory agents. So, it’s more of an issue of production and how production will happen in terms of approval or not. I don’t think there’s any question that these drugs will move forward. And, in the Oncology Drugs Advisory Committee meeting, recently, which was the first to evaluate oncology therapeutics, for both oncology therapeutics that were reviewed— bevacizumab in the morning and our trastuzumab product in the afternoon—there was a 100% vote of “Yes.”
Review: Product Attributes Relevant to Injection-Site Pain, Adalimumab Treatment
May 4th 2024A review article summarized the product attributes of reference and biosimilar adalimumab products, such as formulation with or without citrate, delivery volume, and needle gauge, relevant to patients’ experience of injection-site pain.
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.
Biosimilars Rheumatology Roundup for February 2024—Podcast Edition
March 3rd 2024On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.