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Vivian Bykerk, MD: Using Biosimilars in Treating Patients
Vivian Bykerk, MD, associate attending rheumatologist at the Hospital for Special Surgery, associate professor of medicine at Weill Cornell Medical College, describes her level of comfort with using biosimilars in practice.
Transcript:
Are you comfortable with using a biosimilar for your patient?
I’m comfortable in starting my patient on a biosimilar versus its originator, assuming that it works equally well, that there are no glitches in access, and that the federal government has inspected the makers of that biosimilar as much as they inspect the originators, because I know there is a whole process of compliance and specifications that needs to happen.
I worry that they’re able to do that if they’re made in India or Korea or wherever. I’m not so worried about the biosimilars that are made in this country by the companies that are already making them in this country, because we know there are differences, so I would want to see very careful inspection of the company or manufacturing plants that are making them.
So, let’s assume all of that is the case and the process of accessing the biosimilar is equal to the process of accessing the originator, so you don’t end up with short falls—the needle works as well, the boxes are similar, all of the practical considerations—I think it would be fine.
What I do not want to see is people being forced off of their drug that works, or multiple switching. Even worse, I don’t want to see multiple switching where I’m not told or the patient is not told. For that matter, I don’t want to see [any] switches [at all] where I’m not told or the patient isn’t told.
Q&A With Dr Chelsee Jensen: Navigating FDA Approvals, Challenges in the Biosimilar Landscape
January 14th 2024Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, reacts to the biggest FDA approvals of 2023 and how she sees the adalimumab, natalizumab, and tocilizumab spaces playing out.
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.
IGBA 2023: Dr Monique Mansoura Highlights the Intersection of Geopolitical Issues, Biopharma
February 19th 2023COVID-19 allowed governments to critically examine the biopharma space to increase access to vaccines, but there's still a way to go, according to Monique Mansoura, PhD, MBA, executive director of global health security and biotechnology at the MITRE Corporation, at the International Generic and Biosimilar Medicines Association’s annual meeting.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
