The top 5 most-read conference stories of 2023 recapped some of big biosimilar takeaways from this year’s conferences, including insight into how geopolitics will impact the industry, efforts from government agencies, and strategies to increase biosimilar uptake.
The top 5 most-read conference stories of 2023 recapped some of big biosimilar takeaways from this year’s conferences, including insight into how geopolitics will impact the industry, efforts from government agencies, and strategies to increase biosimilar uptake.
Here are the most-read conference stories of 2023.
5. IGBA 2023: Dr Monique Mansoura Highlights the Intersection of Geopolitical Issues, Biopharma
At the International Generic and Biosimilar Medicines Association (IGBA) meeting, Monique Mansoura, executive director at MITRE Corporation, discussed the impact of geopolitical issues, especially the COVID-19 pandemic, impact drug supply shortages. She stressed the crucial role of pharmaceuticals in national security and highlighted a broader global awareness of key technology access. Mansoura noted a heightened sensitivity to ensuring the resiliency and security of critical assets, reflected in legislative and policy shifts.
4. Dr Michael Chiang: How the National Eye Institute Is Building Confidence in Ophthalmology Biosimilars
Michael Chiang, MD, director of the National Eye Institute (NEI), underscores the NEI's role in addressing retinal specialists' hesitancy toward ophthalmology biosimilars. The NEI aims to support research studies on biosimilars' safety, clinical effectiveness, and cost-effectiveness. Chiang emphasized collaboration with community researchers to gather data that addresses ophthalmologists' specific concerns and advances clinical care, fostering trust in biosimilar usage in ophthalmology.
3. Uptake Barriers Will Deter Future Competitors From Investing in Biosimilars, Julie Reed Warns
At the Festival of Biologics, Julie Reed, executive director of the Biosimilars Forum, warned of barriers like pharmacy benefit manager interference and patents potentially discouraging biosimilar investments. Reed highlighted the financial risks, urging streamlined development by reducing preclinical trials. She stressed the need for updated policies as the biosimilar market matures and proposed increased competition to lower prices. Reed expressed concerns about oversaturation, citing insulin biosimilars' pricing strategies. She suggested strategic pricing structures to navigate formulary challenges, emphasizing the importance of swift changes for long-term market sustainability.
2. Favorable Equivalency Studies of Candidate Biosimilar AVT04 and Reference Ustekinumab
At the 2023 American Academy of Dermatology meeting, Alvotech presented posters on their biosimilar AVT04, showing bioequivalence and therapeutic equivalence to ustekinumab. The bioequivalence study with 298 participants demonstrated comparable pharmacokinetic parameters, supporting AVT04's safety profile. A therapeutic equivalence study with 581 subjects in a double-blind, 2-arm design showed equivalence in Psoriasis Area and Severity Index improvement at week 12 between AVT04 and reference ustekinumab. Safety and immunogenicity profiles were similar in both studies. AVT04's potential as a biosimilar for treating chronic plaque psoriasis was highlighted, with positive outcomes in terms of efficacy and safety.
1. Access 2023: Panelists Weigh In on the Many Factors Influencing Biosimilar Uptake Patterns
At the Access 2023 meeting, IQVIA's Doug Long and Michael Kleinrock presented data estimating $180 billion in US savings over 5 years from biosimilars. Factors influencing adoption, such as manufacturing challenges and payer preferences, were discussed. Kleinrock emphasized biosimilars' role in addressing global challenges like the COVID-19 pandemic. In a panel discussion, concerns were raised about biosimilar utilization under the Inflation Reduction Act. Michelle Holm highlighted issues with average sales price instability. Brenda Motheral stressed the lack of transparency around rebates hindering employer awareness of biosimilar savings and recommended employer-targeted education on approaching pharmacy benefit managers and payers.
Panelists Stress Stakeholder Education to Build Confidence in Biosimilars
October 31st 2024By expanding educational initiatives to clarify biosimilar safety, efficacy, and interchangeability, stakeholders can foster trust, improve access, and ensure that biosimilars are widely accepted as high-quality, cost-effective alternatives to originator biologics.
Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
Strengthening the Supply Chain: Key Insights From FDA Commissioner Dr Robert Califf
October 25th 2024At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, stressed the urgent need for data transparency in the global supply chain and the role of collaboration and artificial intelligence in ensuring the resilience of biosimilar and generic drug production.
What AmerisourceBergen's Report Reveals About Payers, Biosimilar Pricing Trends
May 28th 2023On this episode of Not So Different, Tasmina Hydery and Brian Biehn from AmerisourceBergen discussed results from a recent survey, that were also presented at Asembia 2023, diving into the payer perspective on biosimilars and current pricing trends across the US biosimilar industry.
Calling for Unified Biosimilar Standards, Stronger Education at GRx+Biosims
October 23rd 2024At the GRx+Biosims conference, a fireside chat highlighted the need to streamline biosimilar development and strengthen industry collaboration, with Sarah Yim, MD, of the FDA, emphasizing education's key role in building trust and adoption.
Unifying Standards: The Need for Streamlined Biosimilar Development
October 22nd 2024At the 2024 GRx+Biosims conference, industry leaders and regulatory experts underscored the urgency of unifying global standards and simplifying the biosimilar development process, sharing insights on recent advancements and the necessity for greater collaboration between manufacturers and regulatory agencies.