Gillian Woollett, MA, DPhil, vice president and head of regulatory strategy and policy at Samsung Bioepis, outlines how concerns over the safety and efficacy of biosimilars has shifted and what new concerns the industry is focusing on.
During an interview from the Festival of Biologics, Gillian Woollett, MA, DPhil, vice president and head of regulatory strategy and policy at Samsung Bioepis, outlines how concerns over the safety and efficacy of biosimilars has shifted and what new concerns the industry is focusing on.
Transcript
How has the conversation surrounding biosimilars evolved since the US introduction of biosimilars in 2015?
Woollett: I think one thing that we saw had been somewhat put to rest in recent discussions is any questions around quality of the biosimilars or any unusual or unexpected adverse events, such that those that are experienced in their use are increasingly comfortable as further biosimilars come along.
But in that sense, it's slightly dependent on therapeutic area because say you've had experience with oncology biosimilars, you're comfortable with future oncology biosimilars. So, I think there was a discussion that the business model is more, perhaps, governed by therapeutic area than it is either a more generic model or a more brand model.
So, I think that was one important point, but it does come down to: the science is the bedrock of everything. That if you're consistent as a regulatory authority, it's important for both the confidence in the biosimilars but also the confidence in the regulators, that they're consistent and science-based.
There's an opportunity for much, much greater regulatory efficiency. And that came up, again, as a global issue, perhaps in part due to some of the experiences from COVID-19 but also a general agreement that the science is worldwide. And if we can show some regulatory efficiency, we can get more competitive products more quickly and more affordably. But also we may keep more competitors in this space. So, that was really important, too.
And then there was amongst some, not amongst everybody, the view that, of course, we need biosimilars to allow room in the health care dollar for the next tranche of innovator products, too. And that affordability across the board is as important as anything else to do with biosimilars insofar as everybody wants the originator biologics coming through. And of course, they're the future reference products for biosimilars. So, there was a little bit more optimism around the sort of virtuous cycle of ideas rather than being solely about specific products and some companies feeling a threat to their portfolios.
Coherus Biosciences Cites Biosimilars as Main Drivers of 2023 Revenue Growth
March 14th 2024In its earnings report for the fourth quarter and full year of 2023, Coherus Biosciences detailed its rising revenue growth, which it partly attributed to increased sales for its pegfilgrastim and ranibizumab biosimilars.
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 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.
Filgrastim Biosimilars in Europe: 15 Years of Real-World Evidence for Zarxio
March 13th 2024A review looking back at the last 15 years of experience with the first filgrastim biosimilar (Zarxio) provides a detailed overview on how filgrastim biosimilars came to be and the evidence behind why oncologists have come to accept them as standard practice.
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.
Review: Real-World Evidence Confirms Effectiveness and Safety of Adalimumab Biosimilar SB5
March 9th 2024The adalimumab biosimilar SB5 was reported to be as safe and effective as the reference product in a review of randomized controlled trials and real-world studies on immune-mediated inflammatory diseases.
Eye on Pharma: Canadian Aflibercept Settlement; Sandoz Acquires Cimerli; Payer Chooses Cyltezo
March 6th 2024Biocon Biologics settled with the maker of Eylea (aflibercept), announcing a launch date for its biosimilar competitor in Canada; Sandoz has officially acquired Cimerli, a ranibizumab biosimilar; AARP Medicare Rx from United Healthcare has added Cyltezo (adalimumab-adbm) and removed the originator (Humira) from its formulary.