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Biosimilars Development |
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Biologics have revolutionized treatment of life threatening disease, but remained elusive, as it is not covered by reimbursement in most countries. During this decade several of these wonder drugs are going out of patent and hence a high interest to develop biosimilars to make the drug affordable and accessible.
We bring the benefit of
- Contributing CRO service to ten biosimilar Ph III studies in Asia, Europe and Americas, recruiting over 2000 patients from 120 sites, leading to marketing authorization in national and regional markets.
- Experience on consultative committees for national biosimilar guidelines.
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Experience in Biologics Development for Innovator Companies
During the last decade we have completed clinical trials in Europe for several monoclonal antibodies for Innovator companies leading to marketing registration. This experience of enrolling 4000 patients at 450 sites in Ph II, Ph III and follow on studies have given us knowledge of the standard of treatment and a close relationship with investigators and sites. Seveal monoclonal antibody Innovator biologics are going out of patent in next decade and EMAs regulatory pathway for biosimilars is the most predictable. Most biosimilar programs are planning Ph III studies in Europe for EMA submission. EAs experience becomes valuable in this context.
Experience in Biosimilar Studies by Indication
- Cancer: Solid Tumours
- Rheumatoid Arthritis
- Multiple Sclerosis
- Percutaneous Coronary Intervention, Deep Vein Thrombosis
- Chronic Renal Insufficiency
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Experience by Biosimilar Type
- Recombinant Growth Hormone
- Human GCSF
- Interferon
- Heparin
- Anti Cytokine
- Monoclonal Antibody
Experience by Biosimilar Regulatory Pathway
- EMA
- ANVISA
- KFDA
- DCGI
Consulting Experience
With several sponsors launching studies simultaneously in biosimilars to beat the patent expiry date, it is expected there will be several studies competing for the same sites and investigators. Relevant experience and a long presence in the right countries gives us an advantage over other CROs in developing an appropriate clinical development strategy to take your biosimilar to market on time
Initial consultations are free and we welcome your call. |
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