April 29th 2025
Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
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.
IQVIA Webinar: Enhancing Regulatory Strategies for Biosimilars and Generics
October 14th 2024During a recent webinar, experts discussed critical regulatory aspects for generics and biosimilars, highlighting strategies for navigating complex approval processes, the importance of local market understanding, and the role of technology in enhancing submission efficiency.
BioRationality—The Evolution of the BPCIA and the Bright Future of Biosimilars in the US
October 7th 2024The Biologics Price Competition and Innovation Act (BPCIA) of 2010 initially posed significant barriers to biosimilar development, but regulatory reforms over the years have drastically reduced costs and approval times, with further advancements expected by 2025 that will foster competition and drive down prices.
BioRationality—The Missing Rationality in Biosimilar Discussions and the Path Forward
September 23rd 2024The article by Sarfaraz K. Niazi, PhD, critiques the irrationality surrounding biosimilars, suggesting that regulatory changes and cost reductions in manufacturing could make biosimilars as affordable as generic drugs.
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.
BioRationality: FDA Opens Up Biosimilar Inquiries on Reddit
August 26th 2024Sarfaraz K. Niazi, PhD, urges stakeholders to engage with the FDA on its Reddit forum—where a representative will answer complex biosimilar questions—encourages clearing misconceptions, and advocates for updates to the Biologics Price Competition and Innovation Act guidelines.
Eye on Pharma: Celltrion, Costco Partnership; Amgen Sues Samsung Bioepis; Denosumab Results
August 21st 2024Celltrion's adalimumab-aaty biosimilar is now accessible for all Costco members, while Amgen sues Samsung Bioepis over the latter’s denosumab biosimilar candidate, and GlycoNex progresses its denosumab biosimilar SPD8 to phase 3 trials.
EHA Poster Shows Transfusion Avoidance Rates Were Comparable Between Eculizumab Biosimilar, Soliris
Published: June 15th 2024 | Updated: June 14th 2024A poster from the European Hematology Association’s (EHA) 2024 annual meeting in Madrid, Spain, showed similar rates of transfusion avoidance between patients with paroxysmal nocturnal hemoglobinuria who were administered reference eculizumab (Soliris) and those administered an eculizumab biosimilar (SB12).
DDW 2024 Posters Evaluate Safety, Efficacy, Impact of BMI on Zymfentra Use
May 21st 2024Posters from Digestive Disease Week (DDW) on the ongoing LIBERTY-CD trial assessing Zymfentra, a subcutaneous infliximab product, compared with intravenous infliximab treatment in Crohn disease show the safety and efficacy of the product, as well as the impact of body mass index (BMI) on clinical outcomes.
Partnering for Biosimilar Security: India's Role in US Health Care Savings, Supply Chain Stability
May 9th 2024As Indian pharmaceutical companies supplied 4 of every 10 prescriptions in the US in 2022, generating $1.3 trillion in health care savings, a new IQVIA report highlights concerns about supply chain risks and advocates for partnerships to bolster biosimilar security and overall supply chain resilience.
The Role of Biosimilars: Advancing Access, Financial Health, and System Sustainability
March 11th 2024Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care, a member of the Community Oncology Alliance, and member of The Center for Biosimilars® Advisory Board, glances back at the development of the biosimilar industry and the last 5 years of progress.
BioRationality: EMA Announces Readiness to Waive Comparative Efficacy Studies of Biosimilars
March 4th 2024Sarfaraz K. Niazi, PhD, takes a look at the European Medicines Agency's (EMA) announcement that it will investigate whether comparative efficacy tests should be needed for a biosimilar to receive regulatory approval.
Celltrion, Samsung Bioepis Unveil New Biosimilar Data in CD, UC at ECCO 2024
February 23rd 2024At the Congress of European Crohn’s and Colitis Organisation (ECCO), Celltrion and Samsung Bioepis presented new finding from their respective biosimilar analyses, demonstrating positive safety and efficacy measures for the biosimilars as treatments for Crohn disease (CD) and ulcerative colitis (UC).
Biosimilar Candidate CT-P43 Shows Biosimilarity With Ustekinumab Originator in Plaque Psoriasis
February 13th 2024Similar efficacy, safety, pharmacokinetics, and immunogenicity were found when comparing Stelara, originator ustekinumab, and CT-P43, an ustekinumab biosimilar candidate, in patients with moderate to severe plaque psoriasis.
BioRationality: Bringing the FDA and the USP Together to Revolutionize Biosimilars
February 5th 2024In his latest column, Sarfaraz K. Niazi, PhD, highlights challenges in biosimilar development, emphasizing the crucial role of US Pharmacopeia (USP) and advocating for collaboration and standardized guidelines to expedite cost-effective development without compromising safety or efficacy.