Biosimilars

Fuller definition of Biosimilars, also known as Follow-on Biologics (FOB) or Biogenerics:

A biopharmaceutical that applies the same mechanism of action and has been accepted to possess equivalent efficacy and a similar safety profile to a marketed biopharmaceutical based on a comparative program investigating all relevant properties including a thorough physicochemical comparability, biological activity, pharmacokinetics, pharmacological effect and an appropriate level of efficacy and safety data generated in representative populations.

Key facts to know:

• Between 2009 and 2019 21 blockbuster biopharmaceuticals with a total market value of over $50 billion (US) will lose patent protection
• Development of biosimilars costs $20-80M versus several million for generic drugs, and selling prices will likely be less than innovator products
• There are 150 marketed biologic products worldwide, with over 370 additional products under development
• The highest number of biologicals will lose their patent protection in the areas of oncology, inflammatory and cardiovascular diseases

PAREXEL Consulting, the pharmaceutical consultants are leaders in the development of biosimilars / follow-on biologics, having played an integral role in bringing the first biosimilars to the EU market. To help propel your advantage on the cutting edge of this market, PAREXEL Consulting provides unparalleled expertise from renowned medical doctors, scientists covering all key disciplines, regulatory experts including former FDA and EU regulators, market and reimbursement specialists, and statisticians and clinical research experts.

Based on our leadership position, PAREXEL understands the complex scientific and business challenges you face in this emerging field.  We can also draw on the extensive experience of PAREXEL Clinical Research, which has conducted biosimilar trials involving more than 3,500 patients.

With our strong global presence, we can help you capitalize with a comprehensive, program for the selection, development and approval of any type of biosimilars / follow-on biologics product, any where in the world.

The economic, political and healthcare environments are ripe for development of biosimilars / follow-on biologics with the US Congress currently working on an approval pathway for these cutting edge products. Some predict passage in some shape or form in 2009/2010. Given the complexity and estimated cost of developing and commercializing biosimilars / follow-on biologics as compared to classic drug generics, companies will need to fully understand where their products fall in the biologics continuum, and develop sound strategies and partnerships if they plan to compete successfully in the biosimilars / follow-on biologics landscape. PAREXEL Consulting has the expertise and experience needed to help formulate a successful biosimilars / follow-on biologics program and can bring together regulatory, product development, pharmacology, medical, clinical research, statistical and medical marketing experts to create a tailored comprehensive, effective and efficient development program for development and approval of any biosimilars / follow-on biologics.

Key Offerings

Candidate Selection, Development Strategy and Execution, including:

• Due Diligence of Acquisition Candidates
• Product Development Strategy
• Global Regulatory Scientific Advice Support
• Process Development Support (Qbd)
• Expert Advice on Physicochemical and Biological Comparability Testing
• Expert Advice on Non-Clinical Comparability Program
• Design Clinical Safety and Efficacy Program
• Clinical Program Costs and Timelines
• Conduct Clinical Trials
• Comparative and Cost Effectiveness Strategy and Research
• GCP/GMP Compliance and Pre-Approval Inspection Readiness
• Provide eClinical Technology and Services Support
• Build and Submit Regulatory Applications (E-Submissions)
• Serve as Liaison to Regulatory Authorities
• Market Assessment, Market Saturation Considerations
• Global Market Expansion Services
• Reimbursement and Market Access
• Medical Communications
  
  
  • And, seamlessly take advantage of the fully integrated services of PAREXEL for your biosimilars / follow-on biologics development including: all phases of Clinical Research and enabling eClinical Technologies (IVRS/IWRS, CTMS, EDC, Imaging) to drive efficiency and informed decision-making throughout the product lifecycle.

Value Proposition

Biosimilars / follow-on biologics development requires a highly specialized cross-disciplinary team effort. We apply our fusion of expertise to help ensure your product's success through:

• Selection of viable and vetted candidates for sound investment and development efforts
• Expert-guided development strategies with approval and access in mind that aim to minimize costs and delay and help ensure product lifecycle quality and safety
• Development of your company's biosimilars / follow-on biologics with RMA and profitability in mind
• Effective program management that helps your company meet critical milestones and target approval dates

Contact Us

For further information and to get in touch with our experts, please  use our contact us form and type "Biosimilars" in the comment field so we can assign the right expertise for further discussion. Thank you!