The Center for Biosimilars® recaps the top news for the week of August 27, 2018.
Transcript:
Hi, I’m Samantha DiGrande for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.
Here are the top 5 biosimilars articles for the week of August 27.
Number 5: The Canadian province of British Columbia will begin reimbursing for a second biosimilar infliximab.
Number 4: Carlos Sattler, head of clinical development and medical affairs at Sandoz, spoke with The Center for Biosimilars® about the biosimilar development process and the regulatory landscape that lies ahead.
Number 3: The World Health Organization says that promoting the uptake of lower-priced medicines such as generics and biosimilars will “facilitate efficiency gains without disadvantaging patients.”
Number 2: Gillian Woollett of Avalere Health says many phase 3 trials of biosimilars lack scientific and ethical validity.
Number 1: Pfizer has submitted a citizen petition to the FDA that asks for guidance that clarifies how drug sponsors may communicate about biosimilars.
Finally, last week, our e-newsletter asked whether you think that a new CVS Caremark policy that will allow health plans to exclude high-cost drugs will result in better negotiation on drug prices.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
AAM Report: Generics and Biosimilars Savings Reach $445 Billion in 2023, Part 1
September 18th 2024Savings from generic and biosimilar drugs totaled $445 billion in 2023, showing promise for the growth of both markets and highlighting the success of expansion policies for these products, according to a new report from the Association for Accessible Medicines (AAM).
Expanding Biosimilar Adoption: Insights and Strategies With Dr Sophia Humphreys
September 16th 2024Sophia Humphreys, PharmD, MHA, BCBBS, director of system formulary management at Sutter Health, discusses the challenges of expanding biosimilars into new therapeutic areas and highlights the role of education, competitive pricing, and integrated delivery networks in improving adoption and market growth.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
The Future of Biosimilar Gene Therapies: Key Issues and Potential
September 11th 2024While biosimilars could potentially lower costs and improve access to gene therapies, significant hurdles in regulation, manufacturing, intellectual property, and market size pose challenges to their development and market entry.
BioRationality: FDA Clarification Provides New Indications and Process Change for Biosimilars
September 9th 2024Sarfaraz K. Niazi, PhD, explains the FDA's new guidelines on post-approval changes for biosimilars, emphasizing the processes for reporting modifications, comparability assessments, and the potential for biosimilars to introduce new indications or formulation changes, which could significantly impact their market competitiveness and accessibility.