- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
EMA Launching Pilot to Support Biosimilars Development
The European Union’s European Medicines Agency (EMA) is launching a tailored scientific advice pilot project in February 2017 to support step-by-step development of new biosimilars.
The procedure will advise biosimilar developers on the studies they should conduct, based on a review of the quality, analytical, and functional data they already have available. Standard advice does not include the assessment of existing data, the EMA states.
The pilot is expected to run until it has completed six scientific advice requests, with a maximum of one scientific advice request accepted per month. The program is available to all types of biosimilars, and includes a pre-submission meeting to review the suitability of the data package. The EMA advises biosimilar developers that the data package to be reviewed should be mature in order to fully benefit from the pilot. Data submitted should be directly related to the comparability exercise between the biosimilar and the reference medicinal product and statistical methods used for the comparison of quality data should be presented.
Applicants for the project should provide an overview of the full development plan and include questions related to quality development as well as questions related to the proposed nonclinical and/or clinical development so that the EMA’s Committee for Medicinal Products for Human Use (CHMP) can provide appropriate advice on the next steps of the development based on the quality data available.
The EMA’s Scientific Advice Working Party requires an extra month in addition to normal scientific advice timelines to review applications. A maximum of one Scientific Advice per month can be accepted.
Click here for a link to the EMA’s website showing an up-to-date list of the biosimilars approved in the EU.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Real-World Data Confirm Safety of Switching Between Ranibizumab Biosimilars
March 19th 2025Patients with diabetic macular edema previously treated with a ranibizumab biosimilar in India experience comparable safety and efficacy after being switched to another ranibizumab biosimilar, demonstrating real-world safety of biosimilar-to-biosimilar switching.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Review Calls for Path to Global Harmonization of Biosimilar Development Regulations
March 17th 2025Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.
Retina Specialists’ Evolving View on Biosimilars in AMD Treatment
March 16th 2025The introduction of biosimilars in the treatment of age-related macular degeneration (AMD) is raising concerns among physicians about cost-driven mandates and the autonomy to choose the best therapies for their patients, according to Paul Hahn, MD, PhD, FASRS, a retina specialist at NJ Retina.
