Prerakkumar Parikh, PharmD, director of specialty clinical solutions at Magellan Rx Management, reacts to recent FDA approvals for the first natalizumab and tocilizumab biosimilars.
Prerakkumar Parikh, PharmD, director of specialty clinical solutions at Magellan Rx Management, gives insight into the growing world of biosimilars and the role formulary placement plays in biosimilar adoption.
In the second half of 2023, the FDA approved the first natalizumab biosimilar, which is also the first neurology and first biosimilar indicated for multiple sclerosis, as well as the first tocilizumab biosimilar. Additionally, the FDA approved the first subcutaneous infliximab product and the first ustekinumab biosimilar.
Transcript
From a PBM's perspective, what was your reaction to the FDA approvals of the first MS biosimilar and the first tocilizumab biosimilar?
Yeah, [these are] exciting times as more biosimilars are flowing to the market, especially for newer categories like multiple sclerosis. I'm pretty sure we will see some market shifts happening in that category. Interesting, both [the natalizumab and tocilizumab products] are under the medical benefit right now. So, I think it will probably follow the same success stories of the oncology biosimilars.
Can you explain the role of formulary placement and tiering by PBMs and how these decisions affect the cost-sharing burden for patients who choose biosimilars over reference biologics?
Absolutely. The tiering for some of the biosimilars that have came out are on the specialty tier. So far on the on the pharmacy benefit side, we are seeing the adalimumab biosimilar on that specialty tier along with the brand name product, Humira. So, what that will do is it will allow for access. At the same time, if you have a low-WAC [wholesale acquisition cost] biosimilar at the same level as Humira and if a patient is paying a percentage co-insurance on that specialty tier, a low-WAC biosimilar is going to reduce that cost for the patient as well.
Addressing Patent Abuse, Reimbursement Models Key to Sustainable Biosimilar Market
April 25th 2025Sonia T. Oskouei, PharmD, emphasized strategies to streamline regulations and evolve to overcome barriers and expand the availability of cost-effective biosimilar treatments across more therapeutic areas.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Decade of Biosimilars Yields $36 Billion in Savings and Strengthens Supply Chain
April 24th 2025Dracey Poore, MS, director of biosimilars and emerging therapies at Cardinal Health, highlighted that biosimilars saved $36 billion over the last decade by improving patient access and the supply chain, but continued education and a robust pipeline are crucial for future growth.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.