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Datamonitor Biosimilars Market Access in the US (2016)

February 29, 2016

Datamonitor's independent research and analysis provides extensive coverage of major disease areas, companies and strategic issues, giving you the perspective to identify opportunities and threats arising from shifting market dynamics and the insights to respond with faster, more effective decision-making. This strategy report focuses Biosimilars Market Access in the US including the need for biosimilars, regulatory pathways, substitution and naming policy, legal issues, pricing, reimbursement, and market access.

Highlights

The US has lagged behind the EU in developing a regulatory process for biosimilars.
Biosimilars are expected to deliver considerable cost savings for the US healthcare system.
There are still several uncertainties around the regulatory pathway in the US.
Biosimilars naming is a contentious issue yet to be resolved.
The innovative industry lobby secured a long period of exclusivity for biologics
Patent litigation is being pursued by many originator companies.
Biosimilars are expected to offer at least 20% discounts relative to the brand.
Payers’ drive to promote biosimilar use depends on the indication.

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Disease Group Covered:

Allergy
Autoimmune/immunology
Cardiovascular
Dermatology
Endocrine
ENT/Dental
Gastroenterology (Non Inflammatory Bowel Disease)
Hematology
Infectious Disease
Metabolic
Neurology
Not Specified
Obstetrics/Gynecology
Oncology
Ophthalmology
Orthopedics
Psychiatry
Renal
Respiratory
Rheumatology (Non Autoimmune)
Urology

Additional Resources: