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States Continue to Pass Biosimilar Substitution Laws in 2018
“The Biosimilars Forum is encouraged that so far this year, five more states – Michigan, South Dakota, West Virginia, Wisconsin and Wyoming – have enacted legislation that will help their residents and health care systems benefit from the promise of biosimilars. With 41 states now having passed biosimilar laws allowing substitution of biosimilars designated as interchangeable, patients and doctors can be encouraged that in most states, pathways which support access to these affordable and effective treatment options are taking shape.
“We look forward to policymakers at both the state and federal level continuing to play a role in developing a vibrant biosimilars market, which could lead to a transformation in the way Americans manage serious diseases including cancer, diabetes, rheumatoid arthritis and other chronic conditions.” - Juliana M. Reed, President, Biosimilars Forum.
FDA Information on Prescribing Biosimilars
FDA information regarding the prescribing of biosimilars
State Laws and Biosimilars
Find out about state laws and legislation related to biologic medications and substitution of biosimilars.
Biologics Price Competition and Innovation Act of 2009
The abbreviated FDA licensure pathway law
Biosimilars: More Treatment Choices and Innovation
FDA article on the impact of biosimilars on access and health
FDA Guidance: Scientific Considerations in Demonstrating Biosimilarity
Final guidance to assist biosimilars makers in demonstrating biosimilarity of proposed product to the reference product
FDA Guidance: Quality Considerations for Demonstrating Biosimilarity
Final guidance describes FDA’s recommended factors to consider when demonstrating biosimilarity
FDA Draft Guidance: Clinical Pharmacology Data Use
Draft FDA guidance to assist with design and use of clinical pharmacology studies to support determination that proposed product is biosimilar to the reference product
FDA Draft Guidance: Reference Product Exclusivity
Draft guidance for sponsors developing biological products to help FDA determine date of first licensure for reference product
FDA Guidance: Q&A Regarding Implementation of the BPCIA (2015)
Answers to common questions from manufacturers or applicants interested in developing proposed biosimilar products
FDA Guidance: Additional Q&A Regarding Implementation of the BPCIA (2015)
Answers to common questions from manufacturers or applicants interested in developing proposed biosimilar products (revised from 2012)