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Biosimilar Update: Senate Hearing With FDA & Legislation in California

The Senate HELP Subcommittee on Primary Health and Retirement Security held a hearing this month titled "Biosimilar Implementation: A Progress Report from FDA." Janet Woodcock, MD, director for the Center for Drug Evaluation and Research at the FDA, was called to testify before the committee to provide insight into interchangeability, the pathway for approval, and reimbursement of biosimilar products by CMS.

Sen. Christopher Murphy (D-Conn.) asked Director Woodcock about the department's ability to produce interchangeability and labeling guidelines this year. Unfortunately, Woodcock was unwilling to confirm the date when these guidelines can be expected. However, she did confirm that the FDA will be primarily responsible for educating the community about the biosimilar market in a manner comparable to what is being done for subspecialty generics.

The Committee also inquired about Europe's ability to establish a biosimilar pathway in 2003, followed by production in 2006.

Thirty-one states have considered biosimilar legislation to date. ASPS-supported biosimilar legislation in California is currently awaiting consideration by Governor Brown. ASPS has been actively involved with this legislation through the Alliance of Specialty Medicine.

In March 2015, the Alliance requested that the California state legislature revise the biosimilar legislation to further define "reasonable time" for prescriber notification if a biosimilar is substituted. This detailed definition has been a key element to our support/opposition of numerous state biosimilar bills.

The California State Assembly was amenable to our requests and defined the period as no later than 5 days. In addition, the bill allows physicians to require the script to be filled as written (no substitution) and ensures that patients are notified of any substitution. Governor Brown has until October 11 to sign this legislation.