Empowering Biosimilar Advancements for a Better Future
As the landscape of biologics evolves, Geistek Pharmaceuticals is at the forefront of biosimilar development, offering healthcare organizations, physicians, and patients greater choice and cost-effective alternatives.
With a rich history of supporting biosimilar development, Geistek Pharmaceuticals brings deep subject matter expertise in essential functions such as drug development, clinical study design, regulatory strategy, biostatistics, and regulatory CMC. Our contributions to pivotal trials and key support services have led to global approvals for numerous products across therapeutic areas, including some of the earliest biosimilars.
At Geistek Pharmaceuticals, we offer a fully integrated approach to biosimilar development. Our experts guide you in selecting the appropriate target molecule and developing optimal strategies for commercialization. With insights into drug development, regulatory conditions, and operational capabilities, we ensure timely and budget-conscious program delivery.
Our dedicated Biosimilar Team provides comprehensive support throughout the development process. We assist in the design and execution of global biosimilar clinical plans, collaborate closely with study teams for high-quality outcomes, conduct comparative analytical similarity assessments, and offer supplemental resources to execute and oversee programs. Additionally, we provide strategic consulting, clinical pharmacology expertise, bioanalytical laboratory services, regulatory services, and market access solutions to demonstrate the value of your biosimilar product.
Geistek Pharmaceuticals adheres to stringent regulatory requirements to ensure the highest standard of quality, non-clinical, and clinical comparability data. Our biosimilar development programs are tailored to each specific case, considering the complexity of the molecule, surrogate endpoints, and safety concerns of the reference product or substance class.
Join Geistek Pharmaceuticals on the journey of biosimilar advancements, making a difference in healthcare by expanding choices and improving affordability for patients worldwide.
INTRODUCTION Tecartus is a new advanced therapy approved to treat adults with mantle cell lymphoma (MCL)¹. This disease is a lymphatic system cancer. Specifically, it
INTRODUCTION Kymriah (Novartis) is an advanced therapy medicine that belongs to the gene therapyproduct category. It is approved for B-cell acute lymphoblastic leukemia (ALL) in
INTRODUCTION ¹. CARVYKTI™ (ciltacabtagene autoleucel – Johnson & Johnson) was approved by the U.S. Food and Drug Administration (FDA) in February 2022 for the treatment
