WASHINGTON, DC (March 21, 2013) — “The law signed today in Virginia (SB 1285/HB 1422) to allow for the substitution of biosimilars in that state, while well intentioned, is pre-emptive, and carries burdensome administrative ‘red tape’ that threatens the positive impact biosimilars will have in Virginia.
No one understands the unique nature of biosimilars better than GPhA, whose members have been manufacturing and providing these complex medicines to patients in Europe for more than eight years. GPhA believes, however, that the time to pass this legislation is after FDA guidance has been issued; and that laws put in place should not create barriers between patients and needed medicines.
FDA Commissioner Margaret Hamburg made the point explicitly in a recent speech, stating ‘The high standards for approval of biosimilar and interchangeable products mean that patients and health care professionals can be assured that when those products go to market, they will meet the standards of safety, efficacy and high quality that everyone expects and counts on. Efforts to undermine trust in these products are worrisome and represent a disservice to patients who could benefit from these lower-cost treatments.’
While GPhA strenuously objects to any bill that includes barriers to biosimilar use that preempts FDA guidance, we welcome the Virginia state legislature’s understanding of the need to limit this legislation by including a two-year ‘sunset’ clause. This clause means that the bill will expire in 2015, likely before an interchangeable biologic is approved and available in the United States. This provision reflects the need to fully understand FDA guidance before instituting long-term regulations affecting biosimilar use.
While the final bill with sunset provisions did pass unanimously, it reflected months of discussion and debate that remains ongoing in other states across the country. GPhA urges state legislators to reject biosimilar substitution legislation that preempts the FDA.”