- Bone Health
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Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
On 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.
In today's episode, we'll be diving deep into the crystal ball, exploring predictions for how advancements from the past year will shape the biosimilar market in 2024 and beyond. With approvals, advancements, and regulatory shifts, the landscape of biosimilars is constantly evolving. And who better to provide us with insights into these changes than our returning guest, Julie Reed, executive director of the Biosimilars Forum?
We'll be delving into the impact of recent developments on market dynamics, discussing how these advancements are reshaping strategies, influencing investment decisions, and ultimately, transforming patient care. From the first on-body pegfilgrastim biosimilar to the growing acceptance of adalimumab biosimilars, we'll dissect the key trends and their implications for the future. But it's not just about looking back; it's about looking forward. Julie will be sharing her predictions for what lies ahead in the biosimilar market. What regulatory challenges can we anticipate? How will market access evolve? And what role will innovation play in driving the next wave of biosimilar adoption?
With Julie's expertise and insights, we'll gain a deeper understanding of the forces shaping the biosimilar landscape and uncover strategies for navigating the opportunities and challenges that lie ahead.
For more information on the Biosimilar User Fee Amendments III (BsUFA III), click here.
For more information on the 1-year anniversary of adalimumab biosimilars in the US, click here.
To listen to more of Julie Reed's thoughts on the US biosimilar industry and streamlining development, click here.
To learn more about the Biosimilars Forum, click here.
BioRationality: Withdrawal of Proposed Terminal Disclaimer Rule Spells Major Setback for Biosimilars
December 10th 2024The United States Patent and Trademark Office (USPTO)’s withdrawal of its proposed terminal disclaimer rule is seen as a setback for biosimilar developers, as it preserves patent prosecution practices that favor originator companies and increases costs for biosimilar competition, according to Sarfaraz K. Niazi, PhD.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
Pertuzumab Biosimilar Shows Promise in HER2-Positive Breast Cancer Treatment
December 9th 2024The proposed pertuzumab biosimilar QL1209 demonstrated equivalent efficacy and safety to reference pertuzumab (Perjeta) in neoadjuvant treatment of HER2-positive, ER/PR-negative early or locally advanced breast cancer, offering a cost-effective alternative with comparable clinical outcomes.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Aflibercept Biosimilar MYL-1701P Provides Equivalence in DME Therapy
November 27th 2024The study findings demonstrate that the aflibercept biosimilar MYL-1701P is as effective and safe as the reference aflibercept in treating diabetic macular edema (DME), offering a promising option for reducing treatment costs and improving global access to care for patients with DME.
Ocrelizumab Biosimilar Shows Equivalent Efficacy as Multiple Sclerosis Treatment
November 26th 2024The phase 3 trial (NCT04966338) found that a biosimilar ocrelizumab candidate (Xacrel) was equivalent to Ocrevus in reducing the annualized relapse rate and showed comparable safety and efficacy in treating relapsing multiple sclerosis over 96 weeks.
