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Eye on Pharma: Sandoz Launches Infliximab Biosimilar in Germany
Sandoz, a subsidiary division of Novartis, has launched its infliximab biosimilar, Zessly, in Germany. The launch brings the number of infliximab biosimilars available in Germany to 3.
Sandoz, a subsidiary division of Novartis, recently launched its infliximab biosimilar, Zessly, in Germany. The launch brings the number of infliximab biosimilars available in Germany to 3.
In May 2018, the European Commission authorized the biosimilar for sale in the European Union (EU). Germany will be the first European market where the drug will be available for all indications of the reference product: rheumatoid arthritis (RA), adult Crohn disease, pediatric Crohn disease, adult ulcerative colitis, pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
The approval was based on a review of the data that demonstrated the infliximab biosimilar was equivalent to the reference product in terms of both safety and efficacy. The data included a phase 3 confirmatory study in RA that met its primary endpoint of achieving the American College of Rheumatology’s criteria for a 20% improvement (ACR20) response at week 14.
Reference infliximab, sold as Remicade and developed by Johnson & Johnson (J&J), earned an estimated $6.3 billion globally in 2017. However, increased competition from biosimilars is starting to eat away at its market share. During an investor call earlier this year that discussed fourth quarter sales from 2017, it was announced that Remicade sales fell by 9.7% worldwide.
In the United States, Remicade faces biosimilar competition from 2 products: Celltrion and Pfizer’s Inflectra, and Samsung Bioepis and Merck’s Renflexis. In the European Unoin, J&J’s reference infliximab fights for market share from the same products, though Renflexis is marketed under the brand name Flixabi, and Inflectra is marketed under 2 names: Inflectra and Remsima.
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).
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.
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.
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.
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.
The Role of Coverage Strategies in Biosimilar Market Impact and Cost Savings
September 4th 2024A recent study highlights that although biosimilars have led to significant price reductions, originator products with sole preferred coverage strategies have maintained market share, suggesting that increased biosimilar uptake alone may not fully leverage the market's competitive and cost-saving potential.
