2017 Clinical Trial Strategies & Trends in Biosimilar Drug Development: A higher proportion of bioisimilar development projects is targeted towards regulated markets

Dublin, Jan. 12, 2018 -- The "Clinical Trial Strategies in Biosimilar Drug Development" report has been added to ResearchAndMarkets.com's offering.

As the patent cliff for many blockbuster biologic therapies is approaching, clinical development programs for biosimilar options to those therapies are emerging at a rapid pace. Among the key areas of development is biologics in the autoimmune/inflammation, oncology, and endocrinology/nephrology space. Sponsors of biosimilar projects are carefully designing their trials, assessing the most suitable target populations, and geography.

The concept of interchangeability in the US, where a reference product and a biosimilar are considered freely interchangeable, is not seen in Europe or other developed regions. By gaining an interchangeability status, a biosimilar may greatly enhance its uptake, however the FDA requires that the applicant should strictly adhere to the recently issued Guidelines on Interchangeability. The guideline asks sponsors to conduct a tailored clinical investigation containing multiple elements of switching between the brand and biosimilar as a proof that switching is a safe practice. This report outlines the approaches to switching that various sponsors have adopted prior to the availability of the FDA guidance, and after its publication.

Key Topics Covered:

1 EXECUTIVE SUMMARY

• The volume of biosimilar clinical trials initiated globally is growing
• Autoimmune/inflammation is the top targeted area for biosimilar development
• Oncology biosimilars come as a second choice for biosimilar developers
• Biosimilars in endocrinology/nephrology are progressing through the pipeline
• Some biosimilar sponsors also target therapy areas such as ophthalmology, reproductive health, and multiple sclerosis
• Biosimilar sponsors may employ switching designs in their Phase III trials to demonstrate interchangeability

2 OVERVIEW OF CLINICAL TRIAL STRATEGIES

• Biosimilar development is associated with many risks, but potential high returns
• Comparison of biosimilar approval pathways
• Views on indication extrapolation differ among regulatory authorities
• The FDA outlined requirements for biosimilar sponsors seeking interchangeability status
• Bibliography

3 GLOBAL TRENDS IN BIOSIMILAR CLINICAL TRIALS

• The total number of clinical trials for biosimilar candidates has been incrementally increasing
• The growth in biosimilar clinical trial volume is driven by the expiration of branded drug patents
• A higher proportion of bioisimilar development projects is targeted towards regulated markets
• A diverse range of industry sponsors are involved in biosimilar clinical development
• Biosimilar sponsors carefully choose trial location regions
• The top three therapy areas for the development of biosimilars are autoimmune and inflammation, oncology, and endocrinology/nephrology
• Biosimilar sponsors carefully choose which disease indications to study in clinical trials
• Bibliography

4 AUTOIMMUNE/INFLAMMATION BIOSIMILAR TRIAL TRENDS

• Autoimmune/inflammation is the therapeutic area most often targeted by biosimilar developers
• The most often targeted molecules in regulated markets are anti-TNF therapies
• Biosimilar sponsors initiating trials in A/I indications are joining a highly competitive space
• Analysis of tested A/I indications for biosimilars
• Europe is the most active clinical trial hub for A/I biosimilar clinical development
• Bibliography

5 ONCOLOGY BIOSIMILAR TRIAL TRENDS

• Oncology is the second most often targeted therapeutic area by biosimilar developers
• Sponsors developing biosimilars in oncology are targeting three blockbuster MAbs
• Analysis of biosimilar sponsors conducting clinical trials in oncology indications
• Choosing an appropriate target population for oncology biosimilar trials is essential
• Europe has the highest number of clinical trial sites for oncology biosimilars
• Bibliography

6 ENDOCRINOLOGY/NEPHROLOGY BIOSIMILAR TRIAL TRENDS

• Endocrinology/nephrology is the third most often targeted therapeutic area by biosimilar developers
• Insulin products and erythropoetin stimulating agents are among the top reference choices for developers of biosimilars in endocrinology/nephrology
• Analysis of biosimilar sponsors conducting clinical trials in endocrinology/nephrology indications
• The US is the most active region chosen for the clinical development of endocrinology/nephrology biosimilars
• Bibliography

7 BIOSIMILAR TRIAL TRENDS IN OTHER THERAPEUTIC AREAS

• A key biosimilar target in ophthalmology is the monoclonal antibody ranibizumab
• A key biosimilar target in reproductive health is follitropin alfa
• Biosimilar sponsors also develop biosimilars in hematology, hepatitis C, and multiple sclerosis
• Bibliography

8 PHASE III SWITCHING STUDY DESIGNS AND BIOSIMILAR INTERCHANGEABILITY

• There is a need for data from switching studies
• The FDA has issued draft interchangeability guidelines to shed some light on the issue of interchangeability
• Biosimilar sponsors may conduct switching studies to assess safety and effectiveness of switching between the brand and
• biosimilar
• Bibliography

9 APPENDIX

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